PHARMACEUTICAL & BIOTECHNOLOGY
UPDATE
July 2010
McIlvaine Company
TABLE OF CONTENTS
UNITED STATES PROJECTS
Vermillion Moving Headquarters to Texas
Hopkins APL Breaks Ground on Facility
Jackson Lab Enters Partnership with USF
Emergent Boosts Baltimore Capacity, Plans Lancing Expansion
AAIPharma Partners With CritiTech Over Nanotech
Emergent Opens Baltimore Manufacturing Facility
Absorption Systems Receives Accreditation Renewal
PerkinElmer Radiochemical Solution
Hospira One 2 One to Provide Fill/Finish for Genzyme
Xcellerex Announces Groundbreaking for FlexFactory Biomanufacturing
Millipore Achieves Gold LEED Certification
Shire Buys New Campus in Massachusetts
California Plans New Stem Cell Facilities
Tanabe Research Labs Reopens San Diego Facility
Enavail Opens cGMP Facility in Texas
Almac to Build Cold Storage Units at Headquarters
Proteus Packaging Adds Equipment
Land Acquired for Cancer Treatment Center in San Diego
Work Starts on Brooklyn Bioscience Facility
TRL Refocuses New U.S. Site on Biologic Drugs
Mason University’s Biomed Research Lab Advances Disease Prevention
Max Planck Florida Institute Breaks Ground in Florida
Stanford Gets $5.4 Million for Stem Cell Research
Merck, China's Sinopharm Form Joint Venture
QPS Buys Xendo to Expand in EU
Colorcon Expands Coating Business
Thermo Fisher Plans Japan Biomarker Centre
GPSG Brazil Installs LIMS-Chromatography System
Cisbio Bioassays Has New China Demo Lab
ISCO Partners with IBVI to Set Up Indian Facility
Irish COE May Create 4,800 Jobs
Lab Research Lands Pharma Clients
Irish Pharmaceutical Company Plans Center
CSL to Build $235 Million Manufacturing Facility
Quintiles Partners with the University Malaya Medical Centre
Tekmira Pharmaceuticals Awarded Funding
Millipore and BioOutsource to Collaborate
CSL to Construct New Biotech Facility
Mylan to Buy Ireland-based Bioniche
Mylan Enters U.S. Injectables Market with Bioniche
Tekni-Plex Pharma Packaging Products and Services
Pfizer and Samsung Medical Center to Collaborate
Merck to Close Eight Production Facilities, Eight R&D Labs
Quintiles Setting Up in Malaysia
Synexus Expands Polish Presence
Axxess Pharma's Manufacturing Operations Pass Inspection
Pfizer Invests $100 Million in Singapore Plant
SAFC Plans to Expand Manufacturing
Eurofarma Expands Capacity with Laborátorios Gautier
NextPharma Adds Bottle Filling Line in Germany
Okinawa Institute Starts Second Lab Building Construction
Sanofi to Set Up New Facility in Saudi Arabia
Aptuit to Acquire GSK’s Research Operations in Italy
Almac to Build Cold Storage Units at Headquarters
Saltigo Successfully Completes FDA Audit
Millipore Expands BioPharma CRO Services
Abbott Get India Generics Business
Vermillion said that is moving its headquarters from Fremont, CA, to Austin, TX.
The molecular diagnostics firm, which emerged from bankruptcy protection earlier this year, said that it will continue to perform R&D, regulatory, and quality operations at its facilities in California. All other functions will be conducted in Austin, where the firm has signed a two-year lease on its new principal place of business.
"This move allows us to take advantage of Austin's strong talent pool and cost-effective environment," Vermillion CEO and Chair of the Board of Directors Gail Page said in a statement. "Austin's central location also facilitates more efficient and effective interaction with our national sales force and our strategic partners on the East Coast, such as Quest Diagnostics and Johns Hopkins University, as well as our colleagues on the West Coast, such as PrecisionMed and Stanford University."
Vermillion expects to complete the move in September 2010.
The Johns Hopkins University Applied Physics Laboratory, along with government and construction industry representatives, has broken ground on a new $30 million spacecraft assembly and testing facility.
The facility, dubbed Building 30, is located at the Applied Physics Laboratory campus in Laurel. The building is slated to open in fall 2012. The 47,500-square-foot facility will include optics laboratories, mechanical assembly areas and a high-bay clean room that will be able to support classified or unclassified integration and test operations.
Through its space department, the Applied Physics Laboratory creates systems for NASA and space-related Defense Department missions.
The Applied Physics Laboratory has applied for Leadership in Energy and Environmental Design (LEED) certification for the new building. The new facility will be constructed with recycled materials from the 50-year-old structure that was demolished to clear the way for Building 30.
The Applied Physics Laboratory is a nonprofit division of Johns Hopkins University. It has an annual funding level of about $980 million. The lab has 4,600 employees and a 336-acre campus.
The Jackson Laboratory joined the University of South Florida in announcing a personalized medicine partnership that will include research collaborations, professional training programs, and a clinical initiative, days before a controversial vote by officials in Florida's Collier County on whether to join the Sunshine State in subsidizing the lab's proposed campus near Naples.
The announcement was made on the day an advisory panel of county residents was set to meet to discuss its draft analysis questioning the economic benefit claims made on behalf of the project by a consultant to the public-private Economic Development Council of Collier County. The Collier County Government Productivity Committee, will make recommendations on the project to Collier's five-member Board of County Commissioners.
The commissioners are expected on July 27 to decide whether the county will contribute a $130 million subsidy to Jackson Lab matching a subsidy already approved by Gov. Charlie Crist, now seeking election to the US Senate, and state lawmakers. Jackson Lab has committed $120 million of its own funds, to be raised through a philanthropic campaign.
Jackson Lab and other supporters of the project have said the project will benefit Collier County by bringing their professionals with above-average incomes, and positioning the county as a key player in the state's emerging life-sciences industry — jumpstarted by more than $1 billion in economic incentives to a half-dozen research institutes from the state and local governments.
"Although not quantifiable, it is important to stress that this facility [Jackson Laboratory] will solidify Collier County's position as a leader in the 21st Century life sciences cluster of the entire State of Florida," EDC consultant Washington Economics Group of Coral Gables, Fla., stated in its report.
Supporters hope their arguments will be reinforced through the partnership announced by Jackson Lab and USF. In a memorandum of understanding, both institutions agreed to have their researchers collaborate on computational biology and bioinformatics projects, as well as studies into disorders that include cancer, Alzheimer's disease and the neurosciences, and metabolic diseases.
Michael Hyde, Jackson Lab's vice president for advancement and external relations said USF's resources include a large Alzheimer's research center "which we think promises some synergy with our neuroscience people," and a data-sharing operation focused on diabetes that could mesh with Jackson Lab's diabetes research effort.
Jackson Lab is home to the Type 1 Diabetes Resource, which collects and cryopreserves 20-30 mouse stocks per year that are deemed important to research in type 1 diabetes. The T1DR is funded by the NIH's National Institute of Diabetes and Digestive and Kidney Diseases.
"Here's an organization (USF) with a medical school and a health sciences center located right on the western coast of Florida. It makes great sense for us to become partners and to see where this can go," Hyde said. "We see an awful lot of places where research collaborations could happen."
Research is expected to take place both at Jackson Lab's Florida campus and at USF. Details of the research, and on the number of PIs from both institutions expected to collaborate, have yet to be worked out, Hyde said, adding, "It's pretty early to tell where it will go. What we've done so far is to explore the possibilities. At the administrative level, it looks like things could happen, and now we're going to have to start bringing our people together and exploring the particulars."
Also not yet known, he said, is which other health care organizations might join with Jackson Lab and USF for research and clinical initiatives. "We're not restricting our conversations entirely to local healthcare organizations," Hyde said.
"Researchers and clinicians will work together to bring the latest discoveries into clinical practice, with an emphasis on new medicine that is tailored to respond to the individual," Jackson Lab and USF said in their statement announcing the partnership.
To that end, USF and Jackson Lab also agreed to join with other health care organizations in developing a "clinical campus" to provide personalized medicine and other healthcare to patients from Collier County and beyond. "The partnership will be ideally positioned to provide personalized medicine across a continuum of care, from home therapies to outpatient and inpatient services," the institutions said.
Since the scientific program has yet to be finalized, Hyde told GWDN, "it is difficult to envision what the result of that science would be."
Stephen Klasko, dean of the USF College of Medicine and CEO of USF Health, said in the statement, "We want to give our students and residents an education that will help them become leaders in the new era of genomics-based personalized medicine. The possibilities for collaboration are limited only by our own imaginations."
USF Health consists of USF's Colleges of Medicine, Nursing and Public Health. USF Health and Jackson said they will develop education programs in personalized health, pharmacogenomics, and bioinformatics for professionals in medicine, nursing, pharmacy and emerging health professions. The partnership also said it expects to develop continuing medical education programs to help teach doctors and other practicing health professionals about these new areas of medicine.
Assessing Economic Impact and Cost
The institutions projected that their partnership will enhance economic activity within the "biomedical research and education village" to be created starting with the Jackson Lab project. In a report made public earlier this month, a consultant to the EDC projected that the village and Jackson Lab would generate a total 4,913 jobs by 2020 and 11,490 jobs by 2032.
Jackson Lab projects it will base 244 jobs at its Florida campus by 2020 — though the WEG report says the campus will account for a total 563 jobs throughout Collier County by 2020 and 621 by 2032, apparently reflecting indirect and induced employment attributable to the project.
Concerns over the project's cost and viability have been echoed by the productivity committee. In its economic analysis, it cited projections from Jackson Lab that over its first 10 years, it would generate $552 million in total income. In addition to $130 million each from the state and county, the laboratory estimated it would collect $151 million from donations, $71 million in service and collaborative revenues, $63 million in grants, and $7 million in investment income.
Jackson Lab's Florida campus expects net operating losses each year from 2014 through 2022 to be reduced through donations and investment income, the economic analysis stated.
"The state and county's willingness to provide $260 million to stimulate and diversify Collier County, and a loyalty by Jackson Lab to try to make the project work, is not necessarily the formula for a good business decision," the committee concluded in a draft report analyzing the Jackson Lab project's economic viability.
The committee recommended that "every effort should be made to secure additional revenue from other sources to reduce county tax outlays," including some of the revenues anticipated from royalties generated through the Jackson Lab/USF partnership.
Emergent BioSolutions says additional biomanufacturing space at its Baltimore, Maryland plant could help reduce expenditure through use of new timesaving manufacturing tech.
The US drugmaker said the 55,000 sq.ft. expansion “will allow for the utilization of disposable manufacturing technology to potentially result in lower capital investments, lower operating costs, and accelerated process development timelines.”
At present the facility, which was acquired late last year , produces Emergent’s anthrax monoclonal antibody, BioThrax, the only one approved by the US Food and Drug Administration. However, according to media reports, the firm plans to use the extra capacity to expand its business.
Company director of manufacturing operations told the Washington Post that while the new plant secures Emergent’s position in the anthrax market, it will also enables the firm “to move outside the biodefense realm and into more commercial segments."
And, while details of these “commercial segments” were not disclosed, the paper reported that construction plans indicate that the five existing laboratories at the plant will be combined into two separate units for vial and non-viral vaccines.
This capability would fit with the firm’s product pipeline, which already includes vaccines for the treatment of tuberculosis, typhoid, chlamydia and a universal influenza treatment.
However, while the new Baltimore capacity is an indication of Emergent’s business development plans, BioThrax maintains its position at the heart of the firm’s portfolio as a result of a recent $107m (€83m) manufacturing contract.
The deal, announced to coincide with the opening ceremony at Baltimore, will see Emergent increase BioThrax manufacturing capacity at its plant in Lancing, Michigan to 26m doses.
At present the facility produces a maximum of 8m doses a year, meaning that it will require substantial refurbishment and expansion.
Emergent has outlined plans to demonstrate comparability between the current manufacturing process and the large-scale manufacturing process for BioThrax, and will use part of the funding for process validation, fill/finish and additional studies if required.
The contract was awarded by the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS) as part of an effort to build up its strategic national stockpile.
Commenting on the new contract Emergent CEO Fuad El-Hibri said: "We applaud HHS for its unwavering commitment to strengthen the country's biodefense infrastructure and to protect our military and civilian populations."
Emergent anticipates the production of consistency lots by the end of 2011.
AAIPharma Services Corp., a biopharmaceutical drug product development and contract manufacturing company, and CritiTech, Inc., a nanotechnology company that improves the delivery of therapeutic molecules, have announced a strategic alliance to expand the reach of the CritiTech technology.
This alliance will allow pharmaceutical and biotech companies to choose a novel drug delivery option in early animal toxicology and clinical studies where there is a drug delivery challenge that cannot be solved through conventional approaches. Drug product development and manufacturing will be performed by AAIPharma Services, and drug product intermediate manufacturing will be performed by CritiTech. The two companies will be connected through AAIPharma Services’ best-in-class project management expertise.
AAIPharma Services Corp already offers both its own proprietary drug delivery technologies as well as other technologies through its alliance partners, such as Emisphere Inc. The alliance with CritiTech provides a new drug delivery option for parenteral administration to complement AAIPharma Services already established oral drug delivery franchise. CritiTech’s technology aims to improve the delivery of therapeutic molecules with low aqueous solubility or poor bioavailability. The key benefit of the CritiTech technology is the body’s improved ability to absorb these difficult to formulate drugs. One key differentiator of the Crititech technology is it allows for parenteral administration of drugs which previously could not be administered via this route.
Chief Executive Officer of CritiTech Inc. David Johnston said, “The Alliance with AAI Pharma services allows us to share the established CritiTech technology, used in our Nanotax product currently in development, with a broad range of potential customers. The collaboration with AAI Pharma services and their outstanding product development and manufacturing capability allows us to provide additional drug delivery options throughout the drug product development cycle and to more fully exploit CritiTech technology.”
Chief Executive Officer of AAIPharma's Services L. Lee Karras added, "The alliance with CritiTech allows us to add a breakthrough drug delivery option for our pharmaceutical and biotech customers, whether they are developing a new product or improving an existing product already on the market. The combination of the CritiTech technology and AAIPharma Service's best- in- class drug product development and contract manufacturing services will be of tremendous value to customers. This new offering is in line with our strategy to become the leading provider of complex drug development services to the pharmaceutical and biotechnology industries."
Emergent BioSolutions Inc. held a ribbon cutting ceremony, led by Governor Martin O’Malley and Fuad El-Hibri, Emergent’s chairman and chief executive officer, to mark the formal opening of Emergent Manufacturing Operations Baltimore. Emergent’s new facility consists of 56,000 square feet of manufacturing and office space, and includes multiple manufacturing suites designed to support clinical and commercial manufacture of the company’s rPA, anthrax monoclonal, and tuberculosis product candidates, among others.
The Baltimore facility symbolizes Emergent’s continued investment in manufacturing as one of its core competencies and competitive advantages, said Mr. El-Hibri. It is also a testament to Emergent’s commitment to the State of Maryland, where we are proud to be a key contributor to economic development and job growth.
Maryland has a reputation of being a haven for thriving life sciences and biotechnology companies, thanks to industry leaders like Emergent BioSolutions, said Governor O’Malley. Emergent’s expansion into Baltimore, through the purchase and re-commissioning of this facility, enables significant investment in the biotech infrastructure already in place and ensures that high-paying, highly-skilled jobs are created and remain in Maryland.
Emergent employs over 680 employees across the globe, with 180 employees located in Maryland, where, aside from the Baltimore manufacturing facility, its corporate headquarters and one of its product development sites are located. The opening of this new facility could create an
additional 120 jobs in the next five years.
The company is currently working on modifying and re-commissioning the facility. Planned facility modifications will allow for the utilization of disposable manufacturing technology to potentially result in lower capital investments, lower operating costs, and accelerated process
development timelines. The facility previously operated as a Food and Drug Administration (FDA) licensed facility used by an experienced contract manufacturing organization to produce a number of products approved by the FDA and the European Medicines Agency.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body's immune system to prevent or treat disease. Emergent's marketed product, BioThrax (Anthrax
Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent's product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia.
Absorption Systems, a leader in testing drugs for ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity), announced that its GLP facility in San Diego, Calif., for preclinical testing of drugs, biologics and medical devices received full accreditation from the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC). The company's GLP-compliant facility provides clients with a broad range of services, experimental models and surgical capabilities, offering clients access to specialized technical staff and equipment, rapid turnaround time and competitive pricing.
AAALAC is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. Institutions volunteer to participate in AAALAC's program in addition to complying with local, state and federal laws that regulate animal research. After an institution earns accreditation, it must be re-evaluated every three years in order to maintain its accredited status. Following a meticulous on-site inspection, AAALAC determined that Absorption Systems San Diego facility is committed to the highest level of animal care and research practices, resulting in the facility's accreditation renewal.
"Absorption Systems is thrilled that AAALAC has commended our commitment to exceed international standards of animal care," commented Patrick M. Dentinger, president and CEO of Absorption Systems. AAALAC's renewal of our accreditation demonstrates not only our dedication to responsible animal care and use, but also our pledge to provide our clients with superior resources and services in advancing their drugs, biologics, or medical devices toward IND, NDA, BLA, IDE, 510(k) or PMA regulatory filings.
PerkinElmer, Inc., a global leader focused on the health and safety of people and the environment, announced the introduction of a new GMP compliant radiochemical solution, Lu-177 nuclide. The new compound can be used to investigate more than 30 different clinical applications, including targets for the treatment of colon cancer, metastatic bone cancer, non-Hodgkin's lymphoma and lung cancer.
The manufacturing of GMP compliant Lu-177 supports nuclear medicine centers and pharmaceutical companies around the world that are taking active steps to develop new radiopharmaceutical solutions to create potential “Smart Drugs” for targeted cancer therapies.
Recently, PerkinElmer and the University of Missouri Research Reactor (MURR) entered into a collaborative agreement to upgrade the production of Lu-177 from radiochemical grade to achieve compliance with ICH Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August.
Features and Benefits of Lu-177 include:
Low-energy gamma rays for investigating diagnostic imaging and radiotherapy
Short tissue penetration path length for investigating targeted therapy of small tumors
Relatively long half life of 6.71 days
High purity and radiochemical concentration for optimal labeling efficiency
Custom dispensed for added flexibility and convenience
Genzyme and Hospira have entered a new supply agreement under which Hospira’s One 2 One Contract Manufacturing group will fill and package several of Genzyme’s biologics.
In May, the FDA finalized the terms of the consent decree regarding quality issues at Genzyme’s Allston, MA manufacturing plant, under which Genzyme paid an upfront disgorgement of past profits of $175 million. Genzyme is also required to move fill/finish operations out of the Allston plant for Cerezyme, Fabrazyme and Thyrogen sold within the U.S. by November 28, 2010, and by August 31, 2011 for products sold outside of the U.S.
The new agreement between Hospira One 2 One and Genzyme supplants prior agreements between the companies regarding the filling and packaging of drugs, including Cerezyme, Fabrazyme, Thyrogen and Myozyme. Hospira One 2 One will fill and finish manufacturing services for these medicines, as well as Lumizyme, Thymoglobulin, Campath, and certain products currently being developed by Genzyme. Multiple Hospira One 2 One facilities will be involved in the agreement.
Xcellerex, Inc. announced that it has begun construction of a state-of-the-art cGMP FlexFactory biomanufacturing facility at its headquarters location in Marlborough, Massachusetts. Construction will be completed in September 2010. The facility, the second FlexFactory at the company’s headquarters site, will expand Xcellerex’s capacity to provide bridge biomanufacturing services for clients that are planning or building their own FlexFactory facilities. The plant will also support Xcellerex’s contract manufacturing operations.
Xcellerex President and CEO Guy Broadbent commented, “This facility represents an important milestone for Xcellerex. First, it reflects the surge in interest we are seeing in the FlexFactory platform. The new plant will enable our biomanufacturing services group to support the increased demand for transitional biomanufacturing that we offer to help speed client deployments of their new FlexFactory installations. Second, this will provide a working showcase to demonstrate FlexFactory to the many customers who have expressed interest in evaluating the platform for their next capacity investment.” Finally, he noted, “The timeline in which we will bring this cGMP facility online will dramatically underscore the leap in deployment speed that FlexFactory enables.”
Xcellerex founder and Chief Technology Officer Parrish Galliher added, “This new FlexFactory facility in Marlborough will be a great case study, demonstrating the power of the FlexFactory capability. We will achieve new working capacity in less than six months, at a fraction of the cost required for a conventional facility. This will also give us a hands-on educational tool to help prospective customers achieve a deeper understanding of how a FlexFactory operates.”
The new facility will feature 2,000 liter Xcellerex XDR single-use bioreactors and modular single-use downstream unit operations through bulk-product.
Millipore Corporation, a leading provider of technologies, tools and services for the global life science industry, announced that its Danvers, Massachusetts manufacturing facility cleanroom has achieved Gold level certification under the U.S. Green Building Council’s (USGBC) Leadership in Energy and Environmental Design (LEED) building rating system. This certification, one of the highest ratings for building renovation, acknowledges Millipore’s newly remodeled space for its efficient use of water, energy and waste while manufacturing its single-use technologies.
“We are pleased to receive this designation which exemplifies our commitment to reduce Millipore’s environmental impact in both our products and facilities,” says David Newman, Senior Director, Global Sustainability. “This is a critical project which brings us a step closer towards our overall sustainability objectives.”
This is one of the first cleanrooms to be awarded Gold certification by USGBC and is significant given the energy intensiveness of conventional cleanrooms. Among the room’s new, sustainable features are high efficiency motion-sensing lighting, specialized particulate ventilation sensors which reduce airflow when it’s not needed and locally sourced building materials, many of which are derived from sustainably managed forests.
According to Paul Lukitsch, Millipore’s Worldwide Energy Manager, “It was important for us to design a state of the art clean space. By incorporating innovative design and construction elements, we dramatically reduced the energy used to manufacture Mobius single-use technologies – a key goal given the energy efficient capabilities of the solutions themselves.”
In 2008, Millipore launched a formal sustainability initiative to reduce the company’s impact on climate change, reducing waste and changing employee behaviors. Between 2006 and 2011, the company seeks to reduce green house gas emissions by 20%. Currently, Millipore has already cut its emissions by 14 percent.
Shire plc, a global specialty biopharmaceutical company, announced its purchase of the Lexington Technology Park campus in Lexington, Massachusetts. The purchase signifies an investment in the growth of its Human Genetic Therapies (HGT) business, which focuses on the discovery, development, and manufacturing of treatments for rare genetic diseases.
Shire had previously leased three buildings on the 96 acre campus, and owns the parcel of land on the site where its new 200,000 square foot manufacturing plant is located. The purchase agreement is for the remaining land, including the three existing buildings comprising 280,000 square feet. Through the acquisition, Shire gains ownership of an additional 570,000 square feet of expansion potential available under the current permit, including 170,000 square feet already under construction. The purchase is value enhancing compared to the current lease agreement and has no material earnings impact. The $165 million cash purchase price will be settled during Q2 2010.
"We are delighted to increase our presence in Massachusetts, which is one of the world’s foremost centers for the biomedical and biopharmaceutical industry," said Sylvie Grégoire, President of Shire Human Genetic Therapies. “Shire currently employs 1,000 people in the Commonwealth. This strategic purchase will allow our company greater flexibility as we grow, and enable us to remain focused on the research, development and manufacture of therapies for those suffering from rare diseases."
Bay Area universities and research groups are betting they can spawn a new generation of medical breakthroughs and the next growth engine for the region's biotechnology industry.
The University of California, San Francisco, later this year plans to open a $123 million stem-cell lab at the foot of Mt. Sutro. The building follows the March launch of the UC Davis's new stem-cell center. Not to be outdone, Stanford University this month is expected to complete a $200 million stem-cell facility.
Tanabe Research Labs USA, Inc. (TRL) announced commencement of its new operations at the TRL facility in San Diego with a focus on biological drugs for the treatment of autoimmune diseases. TRL began its new activities in May with the appointment of three new senior executives: Masaki Yamada, Ph.D., Chief Executive Officer; Toshihiro Hosaka, Ph.D., Senior Vice President, and Roland Newman, Ph.D., VP and Chief Scientific Officer.
In its new configuration, TRL will focus its efforts on antibody and biological approaches to target specific immune cells and soluble factors, as well as investigating new methods for modulating immune cell functions. Its ultimate goal is to discover and develop potential biological drug candidates for therapy in autoimmune diseases. TRL expects to hire a number of new scientists in the coming months and to be fully functional by Q4 2010.
Commenting on the re-launch of TRL, Dr. Yamada said, "There is a great deal of relevant scientific know-how in the San Diego region and many opportunities to collaborate with others in pursuing success in similar areas of research. We believe the new focus on biologicals will be very rewarding and we look forward to TRL becoming a significant player in this area." Further explaining plans for TRL, Dr. Newman said, "TRL will not only build in-house research programs, but establish collaborative relationships with other companies and academic research organizations to further its goals of identifying preclinical leads for further development. TRL will continue to re-focus its efforts in immunology in the short term and expand into other areas, including oncology, in the future."
TRL is an indirect wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation, one of the largest pharmaceutical companies in Japan.
Enavail, LLC, a particle engineering company founded on pioneering drug delivery research from the University of Texas at Austin, announced the company’s plans for the construction of a new state-of-the-art current Good Manufacturing Practices (cGMP) facility in the Abilene Life Sciences Accelerator (ALSA). The Enavail facility will be the first of its kind in the West Texas region.
Enavail is an Emergent Technologies, Inc. (ETI) portfolio company, headed by Brian Windsor, Ph.D., President and Breca Tracy, Ph.D., Assistant Managing Director. Enavail’s scientific team is led by Chief Scientist Robert O. (Bill) Williams III, Ph.D., Professor of Pharmaceutics in The University of Texas at Austin College of Pharmacy. Enavail’s particle engineering technologies allow for tremendous enhancement of drugs with poor water solubility – a condition that can greatly limit a drug’s effectiveness.
“The strategic decision to build our new cGMP facility in Abilene was based on a thorough review of our options,” said Enavail President Brian Windsor. “The space and the services the Abilene Life Sciences Accelerator have to offer are a perfect fit for us. They will allow for ongoing support for our clients’ clinical and commercial GMP needs. We presently offer phase I cGMP clinical batch production for compounds with applications in pulmonary, parenteral, intranasal and oral delivery. The Abilene facility will allow us to support all clinical phases as well as commercial manufacturing.”
“Having the GMP facility in the ALSA will better help us to fast-track the growth of our client companies, Abilene and West Texas,” David Sougstad, ALSA Executive Director commented. “It represents a substantial new life sciences manufacturing asset in the region.”
Richard Burdine, CEO, Development Corporation of Abilene, said, “Enavail’s cGMP facility is another first for Abilene in the life sciences industry and a first for the whole West Texas region. It is in keeping with our goal to bring innovative technology to the City of Abilene and this area. It furthers our efforts to provide valuable job and innovation led economic development opportunities for Abilene.”
Utilizing its state-of-the-art lab in Austin and the planned cGMP facility in Abilene, Enavail works with collaborative partners in drug development that are interested in improved formulations, product development and clinical scale manufacturing. Co-development projects usually begin with feasibility studies for development of custom-tailored solutions for partners directed to their specific active ingredient.
These are followed by cGMP clinical batch production and licensing of the Enavail technologies for commercialization of products. In addition to client services, Enavail is in development of its own proprietary pharmaceutical products.
The planned 1,800 sq. ft. facility will be built in compliance with the current Good Manufacturing Practices (cGMP) set forth in the FDA’s code of federal regulations, 21 CFR parts 210 and 211, and will support clinical batch production and commercial scale manufacturing. Facility completion is anticipated by September of this year.
Almac's new North American headquarters facility will feature a 271,000 cubic-foot cold storage unit to accommodate clinical supplies, in particular biologics, which have to be stored at cold temperatures.
The cold storage facility will be equipped with four separate temperature zones, two for drugs requiring refrigeration and two for drugs requiring colder temperatures. The zones range from 77°F to -112°F. The building is also equipped with vault storage for controlled substances.
“Much of the recent demand has been for biologics,” said Dave Setley, head of business development at Almac. “By expanding our cold storage capabilities, Almac is meeting the needs of our clients more efficiently and helping to bring popular pharmaceuticals to market faster.”
The company has also increased its cold storage capacity at its world headquarters in Northern Ireland, adding 150,000 cubic feet.
Proteus Packaging, an international supplier of paperboard packaging solutions, has continued its commitment to meet the evolving needs of customers with state-of-the-art equipment and key industry certifications.
Last year, Proteus became the first U.S. business to install the Heidelberg XL 145 press, which furthered the company’s ability to create specialized packaging solutions with short lead times. Among the benefits of this high-speed press are six-color printing capabilities and a unique inline aqueous coater.
The company is also driving excellence through its key industry certifications. In addition to being cGMP and ISO compliant, Proteus has an excellent rating from AIB International, a third-party agency committed to protecting the safety of the food supply chain. This highly sought-after distinction signifies that Proteus has specific procedures in place – from cleaning practices to maintenance – that safeguard the quality of food items throughout the entire packaging and distribution process.
The company’s growth in these areas is part of a long-term push to meet the increasingly complex requirements of its clients, which includes the company’s move in 2006 to a new 245,000-square-foot facility in Franklin, Wis.
“The pursuit of leading-edge equipment and certifications furthers our goal of being a versatile, reliable partner for a wide range of packaging needs,” said Tim Wayman, executive vice president and chief operating officer of Proteus.
Proteus Packaging is an ISO, cGMP and AIB International-certified provider of packaging solutions for pharmaceutical, nutritional, health and beauty and automotive clients. A privately owned company based in southeast Wisconsin, Proteus Packaging has grown from a regional business to an international supplier with expertise meeting the complex needs of high-volume manufacturers
Cargill's U.S. meat business has launched construction of a $14.7 million research and development facility in downtown Wichita, KS.
In addition to R&D, the new 75,000-square-foot Cargill Innovation Center facility on Wichita Street between First and Second streets and 2nd will have culinary, laboratory, pilot plant and distribution capabilities.
Arco National Construction Co., Inc., is building the two-story complex for Cargill by developer and architect GMA Design Group Inc., both headquartered in St. Louis. The project is slated for delivery in June 2011.
The research and development labs focus on food safety and quality. The culinary kitchens are used for the development of new product offerings as well as the utilization of Cargill products by retail and food service customers.
The pilot plant allows Cargill teams to develop new products and to evaluate new meat-producing technologies that could potentially be employed at the company's full-size plants throughout the U.S. and Canada. The project also includes a food distribution center primarily serving smaller grocery stores in the area.
The new facility replaces a 210,000-square-foot building at 2901 North Mead, which is in an industrial area and was once a meat processing plant. That property was acquired by Cargill in 1978, when it entered the meat business, and it was recently sold.
Rainier Medical Investments, a healthcare investment group, selected Perkins+Will as architect and interior designer for River Walk Medical Park, the medical office campus it is developing in Flower Mound, TX, about 30 miles northwest of Dallas.
Phase I will be a three-story, 80,000-square-foot medical office building. The ground break is set for the fall and delivery is scheduled for summer of next year.
RMI agreed to acquire 21 acres of The RiverWalk at Central Park next to the Texas Health Presbyterian Hospital Flower Mound last month. The closing is anticipated for this month.
"With the new Texas Health Presbyterian Hospital Flower Mound just opening, there is great demand by health care professionals for office space. By working closely with key RiverWalk stakeholders, we intend to break ground late summer. We anticipate the building will be ready for occupancy 12 months from that time," Daryn Eudaly, executive vice president/principal of RMI said in a statement.
Building I will connect from the south side to Texas Health Presbyterian, a doctor-owned building that delivered in late April. The owner has signed nearly 70,000 square feet in soft commitments to lease phase I. Phase II, a 60,000-square-foot structure, will break ground by the end of the year.
Advanced Particle Therapy acquired seven acres at Fenton Technology Park at the southwest corner of Camino Santa Fe and Summer Ridge Road in the Sorrento Mesa of San Diego for the Scripps Proton Therapy Center, a state-of-the-art cancer treatment center using proton therapy that will serve Southern California and beyond.
The Proton Therapy Center is scheduled to break ground in mid to late July and construction should take about two and half years. Scripps Clinic Medical Group and Scripps Health, clinical partners of Advanced Particle Therapy, will operate and provide clinical support at the new facility, the first of its kind in San Diego, said Jeff Bordok, President of Advanced Particle Therapy.
Casey Brown and Mike Colarusso of BCL, Inc. are the local managing partners for the $185-million construction project, along with The Haskell Company of Jacksonville, Florida and Signet Enterprises of Akron, Ohio. Duncan Dodd, SIOR, of Cassidy Turley BRE Commercial represented both the buyer and the seller, H.G. Fenton Company, in the $9 million transaction.
Design has begun on BioBAT, a 486,000-square-foot center for commercial bioscience on the waterfront at the 97-acre Brooklyn Army Terminal co-developed by New York City and State University of New York (SUNY).
Mayor Michael R. Bloomberg, New York State Sen. Martin Golden and SUNY Downstate President Dr. John C. LaRosa announced the start of BioBAT, with construction on the first 56,000 square feet of space beginning this year with completion expected in 2011. The total project will create more than 1,000 permanent jobs.
New York City is home to nine major academic medical and research institutions and they produce between 20 and 30 early-stage bioscience companies annually, but unfortunately, as many of those companies start up and grow, they move away because New York doesn't have appropriate commercial lab space available, Bloomberg said. With the development of BioBAT, along with the East River Science Park set to open this fall, "we are building 10 times the amount of commercial lab space that's currently available," Bloomberg added.
HOK, a global architectural firm with expertise in bioscience, is designing BioBAT. At build-out, spaces from 5,000 square feet to more than 100,000 square feet will be available for lease. The International AIDS Vaccine Initiative developed and occupied 36,000 square feet for its AIDS Vaccine Design and Development Laboratory at the Brooklyn Army Terminal in November 2008. Apath LLC, currently a tenant at the SUNY Downstate Incubator in Brooklyn, has announced plans to expand and relocate to BioBAT.
BioBAT, Inc. is a nonprofit corporation made up of the Research Foundation of SUNY on behalf of SUNY Downstate Medical Center and New York City Economic Development Corp. established to foster development of commercial bioscience R&D and manufacturing space in Brooklyn. The city invested $12 million and State Sen. Golden, working with SUNY Downstate and the City, secured an additional $48 million in state funding.
Tanabe Research Labs (TRL) has revealed details of its new San Diego facility in which the revised layout of the site allows a fresh focus on antibody and biological approaches to autoimmune diseases such as diabetes and rheumatoid arthritis.
TRL joins a plethora of biotechnology companies currently involved in drug discovery for autoimmune diseases. With a biologics sales market projected to hit $55bn in 2014, the potential for big pharma to partner with biotechnology firms in developing biologics remains a lucrative proposition.
In its new guise, TRL intend to focus much of its research on specific immune cells and soluble factors, as well as investigating novel methods for modulating immune cell functions.
The hope is this approach will eventually discover and develop biological drug candidates for therapy in autoimmune diseases. TRL said it expects to hire a team of new scientists and to be fully functional by the end of this year.
"There is a great deal of relevant scientific know-how in the San Diego region and many opportunities to collaborate with others in pursuing success in similar areas of research,” said Masaki Yamada, new Chief Executive Officer of TRL.
“We believe the new focus on biologicals will be very rewarding and we look forward to TRL becoming a significant player in this area."
TRL, a subsidiary of Mitsubishi Tanabe Pharma, Japan, represents its overseas discovery research. Currently Mitsubishi Tanabe’s domestic research operations consist of two sites in eastern and western Japan.
In its annual report, Mitsubishi Tanabe Pharma outlined its desire to expand its worldwide research capabilities by aggressively pursuing joint development with pharmaceutical companies in the U.S. and Europe, and in-licensing and out-licensing of development candidates.
Its drug candidate TA-7284 for diabetes has already been licensed to Johnson & Johnson, in the US and Europe while FTY720, its treatment for multiple sclerosis, has been licensed to Novartis in the US and Europe.
TRL revealed its intention to continue this action, commenting that the new site would not only build in-house research programs, but also establish collaborative relationships with other companies and academic research organizations to further identifying preclinical leads for development.
Through TRL, the Group plans to further expand into the renal disease market with MCI-196 for hyperphosphatemia and MP-146, its indication for chronic kidney disease).
San Diego has long been associated as a haven for biotechnology companies. Not only have companies such as Merck, Pfizer, Dow, and Johnson & Johnson set up operations here, but world-class research institutions such as the Scripps Research Institute; the University of California, San Diego; and the Salk Institute all lie within close proximity to each other.
Biotechnology companies like Neurocrine Biosciences and Nventa Biopharmaceuticals have found their place in San Diego as well as companies, such as BD Biosciences, Biogen Idec, Integrated DNA Technologies, Élan, Genzyme, Cytovance, Celgene and Vertex, who all have offices or research facilities in the region.
George Mason Univ. administrators, faculty, staff and students, as well as elected officials and members of the community, recently celebrated the formal dedication of the university’s new Biomedical Research Laboratory (BRL).
This facility provides Mason researchers with tremendous new opportunities to advance their groundbreaking work on the diagnosis, prevention and treatment of infectious diseases and contribute even more to the national effort to fight bioterrorism.
Mason’s BRL is one of only 13 regional biocontainment laboratories that have been or are being built nationwide through competitive grants from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH).
Representing the U.S. mid-Atlantic region for NIAID, the $50 million, 52,000-square-foot stand-alone facility is located on a secure, 10-acre site adjacent to Mason’s Prince William Campus in Manassas, Va., and features more than 20,000 square feet of lab space.
The dedication of the lab was the culmination of a five-year building project that began in 2005 when Mason was awarded a $27.7 million grant from NIAID. The university provided approximately $20.3 million in matching funds, and the Commonwealth of Virginia committed $2.5 million for land acquisition under former Virginia Gov. Mark R. Warner.
The BRL is managed by Mason’s National Center for Biodefense and Infectious Diseases in the College of Science. It contains highly sought-after biosafety level-3 (BSL-3) laboratories where Mason researchers will develop and test the next generation of vaccines, treatments and diagnostics to protect individuals against bioterrorism and infectious diseases.
Research will focus on newly emerging diseases such as Rift Valley Fever and influenza viruses, as well as on pathogens such as anthrax, plague and tularemia, which the U.S. government considers to be potential bioterror threats.
Vikas Chandhoke, dean of Mason’s College of Science, notes that the work Mason researchers will be conducting in the BRL is important not only to the region, but to the country as a whole.
“The national and international significance of the Biomedical Research Laboratory will afford the College of Science and George Mason Univ. a higher level of visibility among the nation’s research institutions that will present new opportunities to compete for federal and private funding,” says Chandhoke.
“The complexity and significance of the research programs to be implemented in the new facility will attract to Mason some of the most acclaimed scientists in the country, who will in turn develop next-generation vaccines and therapies that will benefit people around the globe.”
Mason is already a respected research Univ. — with more than $100 million in external research funding in 2009 — and the BRL provides Mason’s scientists with the highly specialized facility and cutting-edge equipment they need to take their critical investigations to the next level.
While conducting life-saving research is the laboratory’s ultimate goal, one of the top priorities for the Univ. is the safety and security of the new facility. BSL-3 laboratories have been constructed under the most stringent federal guidelines and are explicitly designed to protect scientists, the public and the environment from the small amounts of biological agents used in research.
Extensive operating procedures and protocols have been established to further ensure the safety and security of the facility and its staff. For example, personnel undergo specialized training before working with infectious agents, including everything from wearing special protective clothing to showering after leaving lab spaces to undergoing rigorous federal background checks prior to being employed by Mason.
“Mason is honored to have been awarded this competitive NIAID grant to build the BRL, which is a tribute to our highly regarded team of infectious disease experts and proven track record of biodefense research success,” says Bailey.
“This is groundbreaking work we will be doing, and we feel certain that our BRL-based research will lead to medical breakthroughs that will ultimately help protect the nation from bioterrorism and outbreaks of infectious disease.”
There was an official groundbreaking ceremony for the new 100,000 sq. ft. Max Planck Florida Institute, taking it a step closer to moving into its permanent location on six acres at Florida Atlantic University’s (FAU) John D. MacArthur Campus in Jupiter. Construction on the new building is expected to be completed by early 2012.
The Max Planck Florida Institute will focus on cutting-edge research in the neurosciences and integrative biology. “Basic research is the key driver of innovation,” Dr. Gruss notes. “The knowledge that we will gain from the Max Planck Florida Institute will create a basis for revolutionary innovations, the foundation on which the world of tomorrow will be built. With the support of Palm Beach County and the state of Florida, this new campus will enable us to fulfill our mission of conducting research at the highest level of quality and excellence.”
An economic study anticipates that the Max Planck Florida Institute will support the creation of more than 1,800 jobs, both directly and indirectly, over the next two decades, and generate more than $2 billion in economic activity. The Institute received significant funding from both the Governor’s Office of Tourism, Trade and Economic Development’s Innovation Incentive Fund ($94.1 million) and Palm Beach County ($86.9 million), $60 million of which is dedicated to the construction of the new research facility. In addition, FAU contributed to the project with a 50-year rent-free lease on the six-acre site (valued at $6.3 million) and the Town of Jupiter weighed in with $260,000 in waived impact fees. This dedication of almost $190 million illustrates the community’s commitment to the future of science.
The new research facility for the Max Planck Florida Institute is designed to accommodate nearly 58,000 sq. ft. of laboratory space that will house wet and dry bench research, instrumentation labs, computational research, core imaging facilities and microscope suites, information technology services, and offices for researchers and support staff.
The scientific facilities will be organized into three research wings including six guest labs to facilitate collaborative research. Conference rooms, a 100-seat auditorium, lounges, and administration offices are centrally located around an open lobby that connects all three floor levels. A large atrium is directly connected to an outdoor terrace on the second floor and provides a central gathering space. The Max Planck Florida Institute aims to also set a high standard for sustainable laboratory design in South Florida.
The Max Planck Florida Institute is currently operating in a 40,000 sq. ft facility on the MacArthur Campus. Among research already under way is The Digital Neuroanatomy group, under the direction of 1991 Nobel Laureate in Medicine Bert Sakmann, Ph.D., which is conducting a program dedicated to creating a 3-D map of the normal brain. The Molecular Neurobiology group, under the direction of Samuel M. Young, Jr., M.D., is studying synapses. Additional research groups are reportedly ready to start operations in July and September.
Four Stanford University School of Medicine researchers have been awarded about $5.6 million for stem cell research projects.
Specifically, the California Institute for Regenerative Medicine is funding projects that aim to discover ways to overcome immune system rejection of transplanted stem cells. The institute is the state stem cell agency created by Proposition 71, and on Tuesday it approved $25 million for 19 projects.
According to the institute, using cells derived from stem cells to replace lost or damaged tissue is a major goal of stem cell research, but it is possible the immune system could potentially reject those cells, similar to how an immune system can reject a transplanted organ.
Three-year grants, each of about $1.4 million, were awarded to four Stanford researchers: Chris Contag, an associate professor of pediatrics and of microbiology and immunology; Robert Negrin, a professor of medicine and chief of the university's blood and bone marrow transplant program; Judith Shizuru, associate professor of medicine; and Kenneth Weinberg, a professor of pediatric cancer and blood diseases and member of Stanford's Cancer Center.
Separately, $885,475 was awarded to Husein Hadeiba of the Palo Alto Institute for Research and Education, which facilitates research and education activities at the VA Palo Alto Health Care System.
The California Institute for Regenerative Medicine has provided Stanford University with a total of about $173 million for various projects since the institute was established in November 2004.
Wild Flavors and its subsidiary Pouch and Pack Concepts is installing high speed pouch filling equipment at factories in the US to meet growing demand for spouted pouches.
Developed by the Indag company of Eppelheim, Germany, the filling machines have already been in operation in Europe supporting the Capri Sonne and Capri Sun businesses.
Capri Sonne and Capri Sun drinks have been packed in pouches in Germany and the UK for years but the packaging format has never really made a big impact on the beverage market. That is now expected to change as beverage companies see it as a cost-effective and environmentally friendly format for on-the-go drinks.
Wild Flavors and Pouch and Pack Concepts expect the additional line capacity in the US to become available by the end of the first quarter of 2011.
A recent study conducted by Proactive Worldwide on behalf of Pack Expo organizers PMMI suggested that pouches could double their share of the US beverage packaging market over the next decade. Currently they hold a value of just $545m in the US.
Environmental considerations are expected to be big drivers in the pouch market as the packs are both light and space-efficient, offering big savings in transportation and storage. The PMMI study said the beverage volume transported in a truckload of quart-sized pouches would require nine trucks of glass or plastic bottles.
And it is not just in the beverage market that spouted pouches are being tipped for success. Guala Group, CFD Corporation and Hosokawa Yoko have recently has teamed up to form a joint venture called Cheer Pack North America targeting the emerging spouted flexible packaging market in the US and Canada.
Cheer Pack president Steve Gosling said flexible pouches aimed at healthy and premium products organics, baby food, yoghurt and ice-cream have big potential.
He said: “There isn’t a huge presence in North America for this type of packaging and we believe there is gap in the market that nobody else has yet tapped into,” he said. “Over the next three to four years, we hope to be producing around 100m spouted packages annually.”
Merck and Co. said it will team up with Chinese drugmaker Sinopharm to market vaccines and potentially other drugs.
Merck will form a joint venture with Sinopharm, cooperating on vaccines for diseases like human papillomavirus in China. Human papillomavirus, or HPV, is a sexually transmitted disease that causes most cases of cervical cancer. Merck makes Gardasil, one of two vaccines approved to prevent HPV.
The companies will discuss teaming up to sell Merck's drugs in the country, Merck said. The companies did not disclose terms of their agreement.
Merck, based in Whitehouse Station, N.J., is the world's second-largest drugmaker by revenue. It said doing more business in emerging pharmaceutical markets like China is a key part of its strategy.
In premarket trading, Merck shares rose 39 cents to $35.66.
Bio Nano Consulting (BNC) says University of London School of Pharmacy deal helped land first Ph I trial formulation services contract.
The UK firm, a nanotechnology partnering focused JV between the University of London School of Pharmacy and Imperial College London, will mange development of an orally-available formulation of a candidate cancer treatment for an undisclosed US biotech developer.
The proof-of-concept project, which will be conducted by researchers at the School of Pharmacy, follows signing of a service level agreement (SLA) with the institution and extends the scope of BNC’s trial support expertise according to CEO David Sarphie.
“The SLA significantly expands our established pool of world class scientist that we manage and draw upon for specific life science projects, including cancer research.”
CRO QPS Holdings has completed its acquisition of Xendo Drug Development (XDD), expanding its presence in Europe.
Netherlands-based XDD operates large and small molecule bioanalytical laboratories and a 24-bed clinical pharmacology unit. QPS believes integrating these sites into its network, which spans Asia, Europe and the US, positions it to expand in the increasingly consolidated biopharm market.
US-based QPS now has 300 clinical pharmacology beds across three continents – 24 in the Netherlands, 24 in Taiwan and 240 in the US. QPS claims this is one of the largest networks of Phase I beds operated by a contract research organization (CRO).
Clients outsourcing to the European unit will also benefit from the accelerated start-up time achievable in the Netherlands. QPS believes Phase I trials can be started in four to six weeks, compared to several months for other nations, making it a location of choice for many biopharm.
These time savings are possible because of the Netherlands’ favorable regulatory environment and streamlined protocol approval process. Costs for managing trials are also lower in the Netherlands, according to QPS.
The acquisition also expands QPS bioanalysis capacity, adding laboratories in the Netherlands to its operations in the US and Asia. Using this network QPS will provide complete ADME packages for regulatory submissions from preclinical studies to radiolabelled human mass balance.
QPS also highlighted its capabilities in central nervous system (CNS) drug research and development. The combined company covers patient stratification, in vivo imaging, PK/PD correlation, clinical genotyping and specialized biomarker assay capability.
Ben Chien, chairman and CEO of QPS, said the firm can offer clients “high quality bioanalysis and Phase 1 studies”, coupled to “expertise in ADME, genotyping and drug development process”.
Colorcon will buy Indian group Pharmaceutical Coatings to expand both its tablet film coating business and presence in “rapidly growing” pharmaceutical market.
The acquisition, which is expected to be completed on August 1, includes the Navi Mumbai-headquartered firm’s portfolio of coatings and excipients as well as its in-construction manufacturing facility in Goa.
Colorcon’s general manager of film coatings, Kamlesh Oza said that: “Asia Pacific is a rapidly growing pharmaceutical market,” adding that “[Pharmaceutical Coatings’] customer base in India was somewhat important to the decision.
“However,” he continued: “Colorcon currently has a strong customer base in the region along with a high quality manufacturing site, technical service laboratory and regional technical and customer support.”
Oza explained that Pharmaceutical Coatings’ broad product portfolio, particularly its range of tablet film coating technologies, was a key driver for the acquisition.
He predicted that these new technologies and platforms will augment Colorcon’s formulation offering across its pharmaceutical, vitamin, herbal and nutraceutical industry businesses.
The deal, financial terms of which were not disclosed, marks the latest stage of a busy program of business expansion and development Colorcon has undertaken over the last few months.
The process began in April when the U.S. firm bought NP Pharma to expand its tablet and capsule formulation business with new manufacturing capacity in Bazainville, France.
A few months later, in June, the firm’s focus switched to South America with the opening of additional laboratory and formulation development capacity at its unit in the Brazilian capital Sao Paulo.
More recently Colorcon, in partnership with Dow Wolf Cellulosics, added to its pharmaceutical excipient offering with a new product specifically designed to direct compression tablet production.
Whether Colorcon will maintain this level of geographical and business expansion activity this summer remains to be seen, but clearly the firm wants to increase activity in emerging markets and bolster its technology offering.
Japanese researchers look set to have another option for biomarker analysis, after Thermo Fisher Scientific unveils plans for Tokyo research laboratory unit.
The new centre, being developed at the Tokyo University Medical Hospital, will provide mass spectrometry-based contract biomarker discovery, development and analysis services.
Murray Wigmore, Thermo Fisher’s Japan spokesman explained that: “In Japan there is an urgent need to develop more targeted disease detection and treatments for a rapidly growing patient population.
COPD, lung cancer and cardiovascular disease, the incidence of which is high in Japan will be a research focus, although the hope is that the centre will provide a forum for collaboration between researchers worldwide.
U.S.-based Thermo Fisher has modeled the unit on the Biomarker Research Initiatives in Mass Spectrometry (BRIMS) centre that its Thermo Electron division set in partnership with the Massachusetts General Hospital in 2004.
In June the U.S. BRIMS unit was the subject of a partnership agreement with contract biomarker services provider NextGen Sciences focused on use of the latter firm’s protein expression platform.
In addition to forming similar partnerships, the Tokyo centre will provide storage capacity for tissue and blood samples collections from trials conducted in Europe and elsewhere.
The announcement of the Japanese project follows a few weeks after Thermo Fisher expanded its drug research business with the acquisition of Canadian technology firm Fermentas International for a reported $260m (€199m).
For the three months ended July 3, Thermo Fisher’s operating income was $312m, up nearly 12 per cent on the equivalent period last year.
The firm’s laboratory products and services business, which will run the new Tokyo project, saw operating income increase 14 per cent to $238m, with revenues growing 63.4 per cent to $1.6bn.
CEO Marc Casper said: “We continue to strengthen our depth of capabilities through investments in technology development and complementary acquisitions that position us to better serve our customers in growing markets.”
However despite these positive comments, the firm cut its revenue guidance for the year to $10.60 to $10.75bn from $10.65 to $10.80bn, citing cost of acquisitions and foreign currency impacts as the basis for its move.
The BRIMS Center is the archetype for the coming Tokyo Biomarker Research Center. The goal is to bring to the collaboration Thermo Fisher's expertise in mass spectrometry-based assays, workflow development and technology integration, as well as its extensive network of collaborators engaged in similar research.
"In Japan there is an urgent need to develop more targeted disease detection and treatments for a rapidly growing patient population," said Murray Wigmore, senior director of commercial operations in Japan, Thermo Fisher Scientific. "The Tokyo Biomarker Research Center will be developed as the model to replicate the excellence of BRIMS in international markets."
Thermo Fisher Scientific Inc. announced that Global Pharmaceutical Supply Group (GPSG Brazil), a unit of Janssen-Cilag, which is a pharmaceutical division of Johnson and Johnson, has implemented an integrated informatics solution consisting of a laboratory information management system (LIMS) and a chromatography data system (CDS). The company will use the system to enhance the quality control in its São José dos Campos pharmaceutical production facility in São Paulo Brazil.
Janssen-Cilag selected the Thermo Scientific CONNECTS solution, consisting of LIMS and CDS, to integrate its many instruments and laboratories. GPSG Brazil now uses the informatics solution in its five laboratories (Incoming; Microbiology; Chemical Lab; Analytical Development and Research & Development), and the solution has been integrated with SAP R3, GPSG's enterprise resource planning system and the enterprise documentation system.
Every month, GPSG Brazil's manufacturing plant in São José dos Campos, processes more than 10,000 analyses to ensure the quality of nearly 2000 samples of raw materials, packaging materials, semi-finished and finished products, in addition to water and stability testing. The site is fully equipped with an incoming laboratory plus microbiological, chemical, analytical development and research and development laboratories. The manufacturing plant handles both solids and liquids, including Tylenol 750 mg tablets, Tylex tablets, Nizoral tablets, Tylenol drops, Nizoral cream and shampoo and imported products such as Eprex and Risperdal tablets. In addition to holding a strategic position in the production of solids, liquids, creams and shampoos, GPSG Brazil imports a wide range of products while exporting to many Latin America countries including Argentina, Uruguay, Paraguay, Chile, Peru and Bolivia.
Given the high sample throughput and the high degree of reliability that is required of a pharmaceutical company, proven systems and equipment are vital to ensure maximum productivity and retain a competitive advantage. GPSG Brazil selected Thermo Scientific LIMS to deploy in its laboratories to ensure integration with the corporate enterprise resource planning package SAP R/3. For GPSG Brazil, the incorporation of product quality information from the laboratory within ERP systems was a clear priority. Between the production plant and the laboratory that analyzes data from production, there is a need for regular exchange of information about quality and analysis values. In order to leverage the full benefits of modern ERP solutions, GPSG Brazil needed a solution to interface the LIMS with SAP so that the LIMS feeds data into the ERP. By interfacing the LIMS with its ERP, GPSG Brazil can expedite the data flow between the lab and the manufacturing functions, streamline data handling and integrate data collection and reports.
This integration of a Thermo Scientific LIMS solution with various laboratory instruments, as well as quality management and enterprise systems, is a vivid example of Thermo Scientific CONNECTS in action. Thermo Scientific CONNECTS bridges the gaps between laboratory generated data and the enterprise level information that is required for mission critical management decisions by providing both the integration of instruments and systems and interoperability necessary to transform data into relevant business drivers for companies across the broadest spectrum of industries.
Thermo Scientific CONNECTS is a set of offerings that leverage the company's breadth of LIMS and CDS capabilities, as well as expertise in enterprise systems integration to help streamline and improve the transfer of knowledge between laboratory-generated data and enterprise-level information systems.
CONNECTS assists organizations in integrating application-specific workflows, thereby transforming laboratory data into relevant business information and maximizing a company's enterprise system investments to better support critical management decisions in today's resource-constrained environment.
According to Ronaldo Galvao, quality operations director, GPSG Brazil, "At the time we selected Thermo Fisher as our vendor of choice, we made the decision to consolidate with a company that has proven expertise in the pharmaceutical industry. We needed a validated product that provides us with sufficient flexibility to deliver all the requirements of a pharmaceutical plant such as data security and consistent quality data, a centralized repository for the Quality Management data, fast and accurate data storage and recovery, and all the industry functionality. The overall integration of our connected informatics solutions provides a seamless and secure quality environment at GPSG Brazil."
Dave Champagne, vice president and general manager, Informatics at Thermo Fisher Scientific. Adds: "Thermo Fisher Scientific works with many of the world's leading pharmaceutical companies to support their manufacturing quality and ensure their ongoing success. We are very happy that Janssen-Cilag in Brazil depends upon our Thermo Scientific CONNECTS integrated solutions to ensure the continued quality of its output. Our growing presence in South America providing informatics solutions to a broad range of industries is strengthened by our work with GPSG-Brazil to support their ongoing production schedules and to improve their processes."
Cisbio Bioassays, a member of IBA group and global developer of HTRF® (Homogeneous Time-Resolved Fluorescence) technology and services used in assay development and drug screening, announced that it has established a new technical support and service laboratory (the HTRF demo lab) in Shanghai, China, thereby reinforcing its business operations in one of the world’s fastest emerging pharmaceutical and biotechnology markets.
The HTRF demo lab enables Cisbio Bioassays to provide enhanced drug discovery services to its pharmaceutical, CRO and academic laboratory customers in China and surrounding areas. Services include seminars on the principle of HTRF technology, custom labeling and assay development, troubleshooting and problem solving, particularly in the areas of G-Protein Coupled Receptor (GPCR) and kinase investigation.
Situated at the Zhangjiang High-Tech Park, the hub of the multi-national pharmaceutical industry in China, the HTRF demo lab was set up in collaboration with China’s National Center for Drug Screening (NCDS), one of China’s leading drug screening centers. The NCDS is affiliated with the Shanghai Institute of Materia Medica (SIMM), a leading drug development research institute, and the Chinese Academy of Sciences.
“Developing assays locally, with locally-produced antibodies, minimizes the logistical hurdles researchers would otherwise face during assay development when they must outsource to third parties in the U.S. or Europe,” said Dr. Bing Xie, director, Asia PacRim, Cisbio Bioassays. “Our new HTRF demo lab will eliminate this problematic for our Chinese customers and enable them, in particular ones who do not have appropriate readers, to better understand HTRF technology and develop their own assays through an accelerated access to our platform.”
“Our second step in China marks an important milestone in confirming our mission to be a best-in-class service- and customer-oriented company in every major market,” said François Degorce, director of marketing for Cisbio Bioassays. “Our Shanghai-based HTRF demo lab now enables us to better deploy our HTRF technology platform with top-notch partners in the area, and provide the same caliber services to our new customers in Asia as we already do in the U.S., in Europe and in Japan.”
Meridian Bioscience confirmed the completion of a $23.3 million cash acquisition of molecular biology reagents firm Bioline. Headquartered in the U.K., Bioline has subsidiaries in Germany, Australia, and the U.S. as well as a distributor network in over 30 countries.
The acquired firm specializes in the large-volume production of nucleotides, DNA polymerase enzymes, and other core reagents and expects 2010 revenues to exceed $12 million. With a portfolio of over 300 reagents and kits for molecular biology, cell analysis, and nucleic acid or protein separation and purification, Bioline also claims to be one of the few manufacturers of ultrapure dNTPs. It offers bulk, custom, and OEM dNTP services for large-scale use or for firms looking to distribute Bioline dNTPs under their own label.
Meridian says the acquisition will pad its own life science product line and provide proprietary know-how in the field of high-volume production of nucleotides and PCR enzymes. “Bioline will provide a rapidly expanding portfolio of highly specialized molecular biology reagents,” remarks Richard L. Eberly, Meridian’s president and evp. “Bioline will also add key global operations and direct sales capabilities in the U.K., Germany, and Australia to complement Meridian’s strong U.S. capabilities."
The firm says that the acquisition of Bioline is expected to be accretive to its earnings in late 2011.CEO, Jack Kraeutler, says Meridian will meanwhile also be on the lookout for new alliances and acquisition possibilities.
International Stem Cell (ICSO) is looking to team up with Insight Bioventures India (IBVI) to establish an India-based development and manufacturing facility for its research products and human stem cell therapeutics. The Indian affiliate will manufacture ISCO’s Lifeline Cell Technology® portfolio of research products, and also develop and manufacture the firm’s stem cell-based CytoCor™ human corneal tissue for the treatment of corneal vision impairment. Under terms of a letter of intent signed by ICSO and IBVI, the latter will lead the funding and establishment of ISCO’s affiliate in Hyderabad, including facilities and staff.
Announcement of the planned partnership comes just a couple of weeks after ICSO confirmed the establishment of a collaboration with India’s Sankara Nethralaya ophthalmology research center and hospital to develop CytoCor for corneal vision impairment.
IBVI is a biomedical business facilitator with a dedicated biofund for financing new businesses in India. The organization has established collaborations with India-based institutions including Sankara Nethralaya, the Indian government-funded Centre for Cellular and Molecular Biology, the All-India Institute for Medical Sciences, and the Indian Council for Medical Research. IBVI says it previously worked in collaboration with Sristi Biosciences to facilitate the early submissions and approvals of stem cell therapy guidelines in India.
“IBVI and their corporate, academic, and government network provide ISCO with an unparallel opportunity to tap into the rapidly growing research product market in India and develop CytoCor with a team of experienced scientists and clinicians in the country with most corneal blindness and visual impairment in the world,” comments Brian Lundstrom, ISCO president. “IBVI’s Biofund investors enable us to do so without ISCO capital investment or issuance of equity shares.”
“ISCO offers our investors as well as corporate and academic partners a unique combination of Lifeline marketed research products with near-term revenue potential in India, and CytoCor with potential to change standard of care for the widespread corneal blindness and vision impairment in India and the rest of Asia,” adds Jayaraman Packirisamy, Ph.D., executive director at IBVI. The collaboration will also provide “an opportunity to apply our well-educated work force and industrial-grade facilities to develop and manufacture these and other biomedical products cost efficiently in India.”
ISCO is focused on developing immune-matched human parthenogenetic stem cells (hpSCs) derived from unfertilized oocytes for the treatment of retinal degeneration, diabetes, liver and neurodegenerative diseases, spinal traumas, and other CNS injuries. The firm claims that unlike embryonic or induced pluripotent stem cells, its hpSCs can be created in a homozygous form that would allow each line to be an effective immune match for thousands or millions of patients. The firm’s Lifeline Cell Technology subsidiary produces and markets specialized cells and growth media for therapeutic research.
A group of Irish drug firms and banks plan to set up a “global pharmaceutical centre of excellence” (COE) that they believe will create 4,800 research, development and manufacturing jobs.
The putative project, news of which was widely reported in the Irish media, is said to be worth as much as €4.7bn ($6bn) and to involve the establishment of a new pharmaceutical campus at Tralee in County Kerry.
Although details of the project are yet to emerge, the Irish Examiner said that Cork-based pharmaceutical firm Pharmadel is the key driving force behind it with, according to the Irish Times, Anglo Irish Bank chairman Alan Dukes also involved.
In a short statement sent to the Examiner the group said that: “We would like to confirm we are engaged in ongoing negotiations to secure the Global Pharmaceutical Centre of Excellence for Tralee.
They added that the project is still in its infancy and that: “It is a long and difficult process and it shall be up to three months before we can announce a conclusive outcome."
The Irish Department of Enterprise (DOE) confirmed that it had met with the group in May, but added that it is awaiting the submission of a more detailed plan.
The project, which would be the largest of its kind in Ireland and increase Tralee’s population by 22 per cent, would be welcome news for the country’s drug industry which has begun to be impacted by competition from lower cost manufacturing destinations.
The COE plan also fits with PCI’s proposed solution to this threat, namely that the Irish drug industry needs to differentiate its offering by developing as an R&D hub.
“[The focus should be on] giving global companies new reasons to base major facilities in Ireland, setting the country apart from competitive economies that are chasing the same investments.”
So, whether anything concrete emerges from the COE project remains to be seen, it appears that some industry players are making efforts to develop increased innovation in the Irish pharmaceutical sector.
Preclinical CRO Lab Research says new contracts are a sign of continuing recovery in market as well as firm’s ability to attract broader clientele base.
Canada-headquartered Lab Research has landed a number of initial study deals with, according to CEO Luc Mainville, five new top 35 pharmaceutical industry customers.
And, while Mainville was unable to disclose the names of the firms involved, he did give Outsourcing-pharma an insight into the type of projects the contract research organization (CRO) will undertake.
He explained that: “We are working on several compounds for some of [the new clients] and the test articles include vaccines, protein therapeutics, peptides and small molecules.”
Mainville also set out the rationale for the work from the clients’ perspective, adding that: “Prices range from $15k to $400k so some are clearly using these studies to validate our ability to meet reporting quality and timelines.”
He went on to explain that: “These first studies are part of a ‘Process’ that allows the client to gain comfort about our ability to deliver,” adding that they follow GLP and animal welfare inspections at Lab Research’s facilities.”
In June, the CRO’s 156,000 sq. ft. facility in Laval, Quebec received formal good laboratory practice (GLP) recognition from the Standards Council of Canada, following a successful inspection. This followed similar awards for its laboratories in Denmark and Hungary.
Preclinical recovery
Setting the contracts in a wider preclinical research industry context Mainville also suggested that: “While we are seeing a pick-up in demand, our client gains also reflect our ability to attract a broader clientele following the addition of key staff, and services.”
This fits with the pattern Lab Research highlighted during its most recent financial results presentation in May when it reported the demand for preclinical work was healthier that in the year-earlier comparable quarter.
Indian contractor Terrene Pharma has filed a DMF for hard gelatin capsules with the US FDA, signaling its intention to expand in the world’s most lucrative drug market.
Company vice president Bhavin Patel said that having entered the expanding pharmaceutical sector in the Middle East and North Africa “we are now actively looking to develop the US market.”
He explained that: “The [DMF] declaration is a must before a potential client can use our capsules to formulate and sell their products in the US” adding that it is “formal recognition that our process of manufacturing capsules meets stringent regulatory standards.”
Patel predicted that: “This will open the doors to quality conscious formulation companies across the globe that are looking to add reliable vendors who can add real value to the top and the bottom line.”
The move fits with comments Terrene made at the inauguration of its Vadodara gelatin capsule manufacturing facility last year, which it said had been designed to comply with US and European regulatory requirements.
Gujarat GMP
Closer to home Terrene recently received good manufacturing practice (GMP) certification from the Gujarat State government for the facility which, Patel added, is part of a wider quality focus.
“Terrene Pharma prides itself on its quality of product and we intend to strengthen our commitment to quality by seeking certification from various regulatory authorities.”
He added that: “We are already in the process of certifying our manufacturing plant as per WHO GMP and filing our EU DMF.” And beyond national and international regulatory filings and submissions, the contract manufacturing organization (CMO) also wants to ramp up its output on the factory floor.”
According to Patel the firm has “established the blue print to triple our production capacities for which we are looking to raise capital via private equity.”
An Irish pharmaceutical business is planning to set up an international center of excellence with the potential to create 4,850 jobs, reports The Press Association. Pharmadel has sourced a site in Tralee, Co Kerry, and is in negotiations with local authorities to secure the location with a reported 4.5 billion euro investment. The ambitious plan would bring in 4,380 graduates, 116 leading academic professors and 321 corporate management executives from around the world.
Australian vaccine maker CSL says new $235m plant will advance development of its portfolio of biotech cancer drugs, anti-infectives and plasma products.
The facility, at CSL’s headquarters in Melbourne, Victoria will develop and manufacture supplies for clinical trials, creating some 330 highly-skilled jobs when fully operational in five years time.
CEO Brian McNamee said the facility will enable CSL to “build on our existing capabilities and research collaborations, further develop the nation’s biotechnology skills.”
The project is being supported by a $30m (€23m) grant from the Australian Government, which is part of an investment package designed to boost health technology in the country.
Quintiles announced a strategic alliance agreement with the University Malaya Medical Centre (UMMC) as part of its Prime Site program, an initiative focused on accelerating the development of new and more effective medicines. The UMMC is the first Prime Site in Asia for Quintiles, adding to its four other sites located in the United States, Europe and Africa.
"Prime Sites are large clinical institutions that collaborate with Quintiles to enhance their infrastructure for conducting clinical trials," explains Christopher Cabell MD. "The University Malaya Medical Centre is an ideal partner for us because of its experience in conducting clinical research, its access to substantial patient populations and its clinical expertise across multiple therapeutic areas. Through this new alliance, Quintiles will be able to significantly improve its reach to patients and investigators who are critical to facilitating the increasingly complex therapies under development."
Professor Dato' Ikram Shah bin Ismail, director of the University Malaya Medical Centre said, "We take great pride in being recognized as a remarkable institution for our long-term commitment and experience in conducting safe and international-caliber clinical research, our clinical expertise across multiple therapeutic areas, and our capability to access a large pool of patients. We believe that this partnership with Quintiles will serve as an impetus for UMMC to achieve greater efficiencies in conducting clinical trials. By enhancing the efficacy, productivity and quality of clinical research at UMMC, we will ultimately propel the advancement of medical practice in improving human health."
From a clinical research standpoint, Asia has long held special promise for the global biopharmaceutical industry's future as companies work to minimize time and cost to market, as well as capitalize on the innovation occurring throughout the region. As an industry and regional pioneer, Quintiles is dedicated to helping its customers navigate risks and seize opportunities in the New Health landscape. This new alliance with UMMC is another example of that dedication and a key step toward enabling the Asia-Pacific region to deliver on its potential in the clinical drug development industry.
Anand Tharmaratnam, MD, senior vice president and head of Clinical Development for Quintiles Asia-Pacific said, "Malaysia is an increasingly important player in Asia-Pacific clinical drug development and the commitment of its government, academic and private industry leaders to promoting leading-edge clinical research in the country is undeniable. This, coupled with the highly skilled clinical workforce, strong clinical research infrastructure and large potential patient populations makes Malaysia and UMMC a quality fit as our first Prime Site in Asia. With the enthusiasm and vision for this model that our UMMC partner has shown, we are confident that this will serve as a strong foundation for our Prime Site program in Asia."
The Prime Site program is yielding results in its established locations at Queen Mary's College in London, UK, the Washington Hospital Center in Washington, D.C., USA, The University of Pretoria, South Africa, and the Southern California Permanente Medical Group, USA.
Tekmira Pharmaceuticals Corp., a biotechnology firm that specializes in gene-blocking treatments, says it has been awarded a multimillion-dollar funding contract with the U.S. Defense Department.
The initial contract, worth up to $34.7 million over the next three years, will advance a therapy that can treat Ebola virus infection for the department's chemical and biological defense program.
The treatment targets the Zaire species of the Ebola virus, which has been associated with outbreaks of hemorrhagic fever in humans and produced death rates reaching 90 per cent.
There are currently no treatments for Ebola or other hemorrhagic fever viruses.
The U.S. government is interested in the treatment to protect soldiers from emerging and genetically altered biological threats.
The contract includes an extension option that could provide the company with up to $140 million in funding for the entire program, Tekmira said.
"This contract is a significant accomplishment for Tekmira and a proud moment for our team," said Tekmira's president and CEO Mark J. Murray.
"This work builds on our recently published research, where we reported that (our Ebola treatment) could confer complete protection to non-human primates from a lethal dose of Ebola virus."
The Vancouver-based company says that around 15 per cent of the contract will be subcontracted to U.S. businesses. Tekmira has a U.S.-affiliated office based in Washington State.
The company says its gene-blocking treatments, known as RNA interference therapeutics, have the potential to treat a broad number of human diseases by "silencing" disease causing genes, and require specific delivery technology to be effective
Millipore Corporation jointly announced with BioOutsource Ltd. that they have formed a strategic alliance. The industry knowledge, scientific strength and modern facilities of the two companies combine to offer a world-class biosafety testing partner that biopharmacetical manufacturers can rely on as an extension of their own quality assurance teams. This collaboration will enable Millipore and BioOutsource to bring a full range of biosafety services to industrial clients who seek a world-class supplier.
The criticality of release testing for vaccine and biological products can create challenges for biopharmaceutical and pharmaceutical organizations, which, in turn, can lead to delays in product development and release. Through the combination of Millipore’s state-of-the-art cGMP facility in Leiden, The Netherlands, and BioOutsource’s custom-built cGMP facility in Glasgow, UK, biopharmaceutical manufacturers can feel confident that their drug products will be produced safely and successfully.
“This alliance offers manufacturers a new alternative for contract testing which will allow them to deploy their resources in other critical areas. For example, these resources can be re-focused on drug development or manufacturing and ultimately reduce a product’s time to market. The complementary nature of both companies’ offerings means customers can benefit from a best-in-class biosafety portfolio, with technical and scientific strength second to none,” says Andrew Bulpin, Ph.D., Millipore’s Vice President, Services and Solutions and Upstream Processing.
“This new joint offering is comprehensive, providing scientific expertise and proven industry experience. Our goals are to help the industry reduce time spent on the development process as well as provide a reliable resource for product release testing to specification within a cGMP environment. This can also lower the necessity of a company maintaining its own cGMP quality control facility within its organization, thus decreasing overall costs dramatically,” says Gerry MacKay, Chief Executive Officer, BioOutsource.
CSL Limited has announced a major biotechnology project at CSL’s manufacturing site in Broadmeadows, Australia.
The centerpiece of the project will be the creation of Victoria’s first large scale biotechnology facility for the late stage development of new therapies for cancer, bleeding disorders, inflammation and infection.
“Our world-class R&D portfolio contains promising life-saving therapies for a range of serious human diseases. This new facility will enable CSL to develop innovative products for clinical trials and future patient use,” said CSL’s CEO, Dr Brian McNamee.
CSL’s Broadmeadows site currently houses state-of-the-art manufacturing facilities that produce a range of highly specialized medicines. CSL’s investment will include enhancements to the site to support the integration of the new biotech facility and to ensure it has the appropriate infrastructure to cater for expanded activities into the future.
The project will represent a total investment of $235M over 4-5 years and will result in 320 jobs during construction. Following completion, the investment will create over 330 new highly-skilled positions.
“CSL is proud to be investing in a project that will not only generate significant employment opportunities, but will also have enormous spill-over potential for our biotechnology sector and medical research community” said Dr McNamee.
“This significant project enables us to build on our existing capabilities and research collaborations, further develop the nation’s biotechnology skills and work towards our important goal of improving the lives of people with life-threatening disease.”
Bosch Packaging has identified Asia as a key engine for future growth as its chief announced its international presence had helped the firm to “stand our ground in the global market place” during a tough 2009.
The German-based company highlighted China as a vital growth market for both its food and pharmaceutical divisions as it launched a range of systems into the Chinese sector for the first time at the ProPak trade show currently taking place in Shanghai.
Bosch declared that its 2009 sales of €675m had only experienced a drop of four per cent in sales compared to the previous year.
Food and confectionery segments were particularly affected in the first part of the period, although they recovered in the second half of the year. However, the performance of its pharmaceutical division was almost untouched.
“Despite the economic downturn we have been able to stand our ground in the global marketplace,” said Friedbert Klefenz, Bosch Packaging Technology president. “As expected, the difficult economic conditions impacted on our sales development in 2009.
During the first few months of the year, this concerned primarily the food and confectionery sectors. In the second half of the year, however, an upward trend emerged. Moreover, pharma and services were largely unaffected by the crisis. For these divisions, order levels remained high.”
Asia
The company said keeping costs down and its policy of internationalization had been key in its 2009 performance with 86 per cent of its packaging business realized outside of Germany. Unsurprisingly, its strongest market remains Europe – including Eastern Europe - at 50 per cent, with North America next, accounting for almost half that amount.
However, Klefenz, hailed the performance in Asia which was responsible for a fifth of the company’s total sales “with a clear tendency towards further growth”. Last year, the region experienced the strongest growth for order intake – with the pharma sector in China especially buoyant.
Pharmaceuticals account for 50 per cent of all the company’s orders, followed by food on 35 per cent and confectionery on 14 per cent.
The Bosch president also forecast further overall growth for the company this year by inflating its international presence.
“For 2010, we are expecting further growth in our core areas of pharma, food and confectionery, mainly by expanding our global presence and thereby widening our customer base,” he said.
Importance of China
The company said China was its most important growth sector in all the emerging markets. It has doubled its production capacity at its recently expanded 9,000 sq. meter-Hangzhou plant – (96,840 sq. ft.) which serves the local market for “cost-effective by high quality” products. There is also a rising demand for complex, high-performance installations which are produced with the support of Bosch's European operations. The supply of automation technology solutions to the emerging markets is also showing a steady increase, added a statement from the firm.
Mylan Inc. will buy Bioniche Pharma Holdings Ltd., a company that makes injectable drugs, for $550 million in cash.
Private equity firm RoundTable Healthcare Partners owns a majority stake in Bioniche. Mylan said Bioniche has about 30 products on the market. The Ireland-based company focuses on injectable drugs that have limited competition and which are difficult to develop and manufacture. Bioniche posted around $130 million in revenue in the 12 months ended May 31.
ICC Private Equity Fund, which is managed by the venture capital division of Bank of Scotland Ltd., is selling its stake in the company, too.
Bioniche's products include analgesics and anesthetics, and drugs used in orthopedics, oncology, and urology. The drugs are mainly sold to hospitals, and most of the company's sales are in the U.S. Mylan said the deal gives it an entrance into the North American market for injectable drugs.
Mylan said it will combine Bioniche with its own UDL Laboratories to form a new unit called Mylan Institutional. It will not take on any of Bioniche's debt or its cash. The purchase is expected to close within 60 days, assuming regulators approve. Mylan expects Bioniche to add to profits in the first year after closing.
RoundTable acquired its stake in BioNiche in February 2006.
Mylan is to acquire Bioniche Pharma’s global injectable pharmaceuticals business for $550m (€430m) in a deal that gives Mylan a significant foothold in meeting product and therapeutic gaps in the US injectables market.
The deal to buy privately-owned Bioniche is likely to add to the generic-drug producer's earnings in the first year after closing. Ireland-based Bioniche posted revenue for the 12 months ended May 31 of $130 million with much of its sales achieved in the US.
Mylan stated it would not assume any of Bioniche's outstanding debt or purchase its cash in the deal, which it will finance with available cash and borrowings. The deal is expected to close in 60 days.
The deal gives Mylan an entrance into the lucrative North American market for injectable drugs – an industry worth in excess of $25bn in sales.
Market research analysts attribute the sector’s growth to the rise in patient demand, healthcare and pharma cost containment, as well as medical and technological advances.
The deal gives Mylan a whole host of additional products and drugs that are mainly sold to hospitals in the US. These products include analgesics and anesthetics with drugs used in orthopedics, oncology, and urology.
Bioniche will form part of a venture in which Mylan's unit dose business, UDL Laboratories, will merge with Bioniche to form Mylan Institutional. The business will target the hospital/institutional sector in the North American region of the company's generics segment.
Mylan also gain control of Bioniche investments made in bolstering its pipeline. This pipeline includes 15 abbreviated New Drug Applications pending approval by the US Food and Drug Administration (FDA) as well as more than 25 additional products in various stages of development.
Bioniche Pharma is a global manufacturer of injectable pharmaceutical products serving a variety of niche markets, with expertise in injectable hyaluronic acid products for use in orthopedics, rheumatology, urology and dermatology.
The company’s growth is fueled by an internal development pipeline and an aggressive acquisition strategy for products. Bioniche Pharma was acquired in February 2006 by RoundTable Healthcare Partners, a private equity firm based in Lake Forest, Illinois.
“Our manufacturing and packaging facilities are located in Galway in the west of Ireland. They are US Food & Drug Administration (FDA) and Irish Medicines Board (IMB) approved, as well as being ISO EN 13485 accredited by Amtac (manufacture and sale of medical devices), which allows use of the CE mark.”
To meet ever-increasing production demands and the prospect of even greater growth in the future, we have recently completed a new, state-of-the-art sterile filling facility also located in County Galway. Its completion adds another 21,000 square feet of production space and almost doubles our total manufacturing capacity.
The new facility has substantially increased both our vial and syringe capacity. Based on the current mix of vial sizes, vial capacity is now at 5 million units per year, while our syringe capacity has increased from 1 million units to 3.5 million units per year. The new facility meets all international standards for sterile injectables.
Tekni-Plex, Inc. (King of Prussia, PA) is focused on growing its pharmaceutical packaging and medical device business segments, after implementing broad reforms to restore corporate profitability.
Since a financial restructuring two years ago, the global manufacturer of packaging and tubing products has maintained investment in its core businesses, and is planning for continued growth, says Paul Young, CEO, Tekni-Plex.
“In the first 18 months, we cleared away a lot of the debris. Now, as a smaller but more profitable company, we are focusing heavily on profitable growth. We have invested over $40 million since 2008, with a great deal of that going to the healthcare businesses,” Young says.
“We have improved earnings by over $30 million over the last two years, on about $200 million less in sales. (And) we expect that fiscal 2011 will be the best year in a long time in this company’s history,” Young adds.
Through a string of acquisitions since its founding in 1967, Tekni-Plex grew into an $800 million company with businesses in healthcare, foods, consumer products, and specialty markets. Left vulnerable by increases in raw material costs, weak operating results, and high debt, the company completed a financial restructuring in 2008. Oaktree Capital Management and Avenue Capital Corp. acquired a controlling interest in a debt-for-equity swap.
Young was hired soon thereafter from Graham Packaging Holdings Corp. as CEO to execute a turnaround plan and run the business.
“The company was paying about $100 million in cash interest annually on $800 million of debt. All the available cash was going to service the debt.” In the restructuring, about $300 million of debt was converted to equity, reducing the annual interest payments by about $50 million. “Then the free cash became available for improving the business,” Young says.
“There were three things we had to do: Solve the liquidity issue; put the domestic business on a solid footing and stop the bleeding operationally; and strengthen organizational capabilities and talents,” he says.
New upper management and business segment leaders were hired. Company-wide budgeting and forecasting was implemented. Unprofitable businesses were downsized or eliminated in a reorganization of manufacturing and product lines.
“Tekni-Plex was run similar to a holding company, with low interaction between businesses and loose controls on policies and procedures. It was really a matter of addition by subtraction—getting rid of the businesses that were not performing well,” says Young.
Most of Tekni-Plex's problems stemmed from non-packaging segments that had threatened to undermine the whole company.
Burlington Specialty Resins, a manufacturer of non-pharma grade PVC that lost $27 million over seven years was shut down. Three Dolco Packaging Corp. plants were closed as the company exited the consumer PS plate segment.
The garden hose business was “drowning in a sea of capacity with no demand and very high costs. We had to take a meat ax to the cost side, shuttered some plants, improved the efficiency of others, accelerated new product development, and worked on our pricing,” Young says.
New leaders were hired in four of Tekni-Plex’s six business segments, with other top managers promoted. The company also hired a new CFO, and added functions that were missing in the old Tekni-Plex organization.
“Tekni was buying $300 million in rubber and polymers with no common procurement function. We brought in a new VP of procurement to bring cost discipline to purchasing; that has translated to an improved value proposition for our customers,” Young says.
Tekni businesses that performed well through the rough years of 2006-2008 included the European division. Luc Vercruyssen, managing director of the Tekni-Plex wholly-owned European subsidiary Tekni-Plex Europe NV reports to Young. “Our business in Europe has continued to flourish. Recent investment in state-of-the art pharma and medical films technology had driven growth in many different applications.”
New investment is planned in the $250 million healthcare businesses. Segments include pharmaceutical packaging, and compounds and components, and liners and films for medical and drug delivery device manufacturing and packaging.
“In the last six months, our focus has shifted from fixing the company and surviving in a recession (to strategic growth). We have strong market positions in these businesses. Many businesses were siloed to a large extent (and) never grouped with a market focus. We are trying to unlock a lot of cross-selling opportunities,” Young says.
Philip Bourgeois joined the company from Rexam Plastics Packaging as the head of technology development and regulatory affairs. He is initially focused on development of all of the healthcare business—including the closure liner and seal business which includes the Blauvelt, NY-based Tri-Seal operations.
Tekni-Plex Europe NV last year bought Top Seals Dichtungseinlagen (Hanover, Germany). About 20% of the liners and gaskets the company produces are used in healthcare applications.
“We are really pushing the closure liner business as we see a great need in our customer base for a strong number two supplier to compete on innovation, quality, service and price,” Young says.
The flexible films, elastomers, and tubing businesses are branching out.
Two facilities for manufacturing vinyl compounds used for tubing and device injection molding in Belfast, Ireland and China, have recently expanded capacity, adding to US-based capacity in vinyl compounds.
Production of film liners used in bio-reactors has been launched at a facility in Belgium.
In extruded products for spray pumps and dispensers, “a superior world class operation” in Italy complements gasket and grommet manufacturing by American Gasket and Rubber in the US.
In pharmaceutical blister films, customers will benefit from a one-stop-shop approach.
John Zripko, vice president, pharma-Americas, oversees blister film manufacturing operations in Canada, New Jersey, and South America.
Tekni-Plex plans to invest $6 million this year in the domestic film business, in projecting blister film market growth at 6 to 8%. “In addition, we are seeing excellent growth in our high-barrier film business in Latin America,” says Young.
“We have made many improvements on the film processing side, and more are planned.
“Across the board in all of our business, you will see a lot of new products in the next 12 to 18 months,” Young says.
Quotient Bioresearch, a leading provider of early stage and specialist drug development services to pharmaceutical, biotechnology and medical device clients worldwide, announced that its new, state-of-the-art radiochemistry facility in Cardiff, UK is fully operational and that shipments of radiolabelled products have commenced.
All staff have successfully transferred from the former site operated by Amersham Radiolabelling Services to the new facility.
The new facility, located close to Cardiff Bay, represents a significant investment by Quotient and follows the Company's acquisition of Amersham Radiolabelling Services from GE Healthcare in June 2009. The facility has been named "The Old Glassworks", reflecting the origins of the site on which it was built.
The Old Glassworks will produce radiolabelled compounds for its pharmaceutical, biotechnology and agrochemical clients, offering an established bespoke service for the custom synthesis of carbon-14 and tritium labeled compounds. Quotient's capabilities allow it to manufacture custom radiolabelled drugs for use in both pre-clinical and clinical settings.
Quotient offers its clients a unique range of services with world-leadership positions in a number of key disciplines, including custom radiosynthesis services and carbon-14-enabled drug development. With its strong existing client base in Europe, the United States and Japan, Quotient will serve over 250 clients worldwide from The Old Glassworks. Its chemists work closely with the company's metabolism and clinical research groups to deliver clients the most effective solution for their carbon-14 enabled drug development needs, reducing complexity, cost and timelines.
The Old Glassworks has been equipped with world-class technology, operating to the highest environmental and safety standards. It houses the largest and most experienced team of radiosynthesis chemists in the world and brings the total number of Quotient employees to over 600.
Paul Cowan, Chairman & Chief Executive Officer, Quotient, said, "With the opening of the new Cardiff facility, we have made a significant investment to support the product development needs of our pharmaceutical, biotechnology and agrochemicals clients. We have invested significantly in technology that will make the business operate sustainably and allow our expert chemists to efficiently deliver the highest quality products to our clients. With almost one-third of all registered drugs on the market today having been radiolabelled by Quotient chemists, the opening of The Old Glassworks will allow us to continue to expand on this record of success."
Stephen Lewinton, Managing Director, Quotient Chemistry and Metabolism, said: "The new facility demonstrates our commitment to the radiochemicals business and allows us to build on our fully integrated carbon-14-enabled drug development services (including Synthesis-to-Clinic). Quotient remains focused on meeting the needs of its clients for cost-effective custom radiosynthesis services."
The last of the chemists transferred to The Old Glassworks as scheduled in early May, as planned. After rigorous safety and emissions testing, The Old Glassworks is now fully operational and the first products have been shipped. An official opening ceremony will be held in September 2010.
Samsung Medical Center and Pfizer have formed a research partnership to jointly analyze tumors from Korean patients to generate gene expression profiles and that may ultimately direct therapies and enhance clinical outcomes in the patients with liver cancer.
The two organizations held a signing ceremony at the main conference hall located on the fifth floor of Samsung Medical Center in Seoul on June 14 to commemorate the initiation of the collaboration. A research team led by top scientists at Samsung Medical Center, including Prof. Park Cheol-Guen, Prof. Im Ho-Young and Prof. Paik Soon-Myung, Director of the Cancer Research Center, will conduct research in Seoul, while Dr. Neil Gibson, Vice President of Oncology Research, will be responsible for the joint research program at Pfizer.
Pfizer expanded into the market for targeted anticancer agents with the launch of Sutent, an anticancer agent used to treat an advanced form of kidney cancer. Since then, the company has been consistently investing in research and development of innovative drug candidates and potential treatments for patients with liver cancer, a type of cancer especially prevalent in Asia, to address the growing need for an anticancer drug treating liver cancer in the Asian market in the future. Seeing the world-class clinical environment and outstanding research capabilities in Korea, the global pharmaceutical company formed a research partnership with Samsung Medical Center as part of its commitment.
Samsung Medical Center has been laying the solid foundation for development of new anticancer drugs, providing top-quality medical service through organic collaboration with other organizations; building an extensive base of specimens in the liver cancer area; and accumulating the know-how for diagnosis and treatment of liver cancer.
Samsung Medical Center was named to join the "Group of Leading Research-based Hospitals," a large-scale national project led by the Ministry of Health and Welfare in 2009, to work with leading local and global pharmaceutical companies for an open research project designed to develop novel bio drugs that will help the country to cure intractable diseases.
"We are pleased to have an opportunity to work with the world's No. 1 pharmaceutical company Pfizer to better understand cancer in Korean patients, with the goal of being able to send a new message of hope for patients with liver cancer across the world (especially in Asia)," said Choi Han-Yong, president of Samsung Medical Center.
"This partnership will serve as a great opportunity to combine Pfizer's know-how in drug development and Samsung Medical Center's extensive genome information and technology in the liver cancer area," said Neil Gibson, vice president of Oncology Research Unit in Pfizer Inc. "We further plan to share the ownership of collected and analyzed data with Samsung Medical Center, contributing to advance of a variety of oncology research in Korea." Pfizer signed a memorandum of understanding with the Ministry of Health and Welfare in 2007, agreeing to invest 300 million dollars in R&D in Korea. As part of its commitment, the company also formed a strategic partnership with the Korea Research Institute of Bioscience and Biotechnology and has been leading joint research since then.
The LSD of the Philippine Food and Drug Administration (FDA) has taken a step towards raising standards by gaining ISO/IEC 17025:2005 accreditation.
Gaining the accreditation equips the Laboratory Services Division (LSD) to determine the quality of anti-tuberculosis drugs. “This is a milestone not only for the FDA, but for the people of the Philippines and the surrounding region”, said Maria Lourdes Santiago, chief LSD.
Support for the LSD was provided by the U.S. Agency for International Development (USAID) and the Promoting the Quality of Medicines (PQM) program. PQM is implemented by the U.S. Pharmacopeial Convention (USP).
Merck & Co is to close or sell eight manufacturing plants and a further eight R&D laboratories as part of efforts to cuts its workforce by 15 per cent.
Acquiring Schering Plough for $41bn (€32bn) left Merck with 91 manufacturing facilities. Phasing out of activities at the eight plants, coupled to other actions taken since the merger, will leave Merck with a network of 77 facilities which it will supplement with contract manufacturing deals.
Of the eight sites Merck is cutting four are in Latin America. Merck will end manufacturing at facilities in Azcapotzalco and Coyoacan, Mexico and Santo Amaro, Brazil. It is also looking to sell its facility on Mirador, Argentina.
However, Merck highlighted that it is also investing in Latin America. For instance, it is working to increase capacity at its facilities in Xochimilco, Mexico and Campinas, Brazil. These projects form part of Merck’s plans to continue making strategic investments, particularly in emerging markets.
Other than the cuts in Latin America, Merck’s manufacturing and R&D sites in emerging markets are largely unaffected by the plans. Chemical production is being phased out at one site in Singapore but pharma manufacturing will continue and its other plant there is unaffected.
The remaining manufacturing facilities Merck is stopping production at are in Comazzo, Italy and Cacem, Portugal. Merck is also seeking a buyer for its production plant in Miami Lakes, Florida, US.
R&D laboratories
Merck is also exiting eight R&D laboratories to trim its global network down to 16 major facilities. Despite the cuts Merck expects to retain clinical and regulatory affairs expertise in all major regions and believes it is equipped to develop biologics, small molecules and vaccines.
Operations at Montreal, Canada; Oss, Schaijk and the Nobilon facility at Boxmeer Netherlands; Odense, Denmark; Waltrop, Germany; Newhouse, Scotland; and Kendall Square, Cambridge, Massachusetts, US will be phased out over the next two years.
The remaining sites include several large multidisciplinary sites that will provide capabilities and resources to number of research franchises and respond quickly to change.
Merck is making these cuts as part of the initial phases of its merger restructuring program which is targeting a 15 per cent reduction of its global workforce. In some areas of the business Merck will continue to hire.
Making these cuts is predicted to result in pre-tax costs of $3.5bn to $4.3bn. However, the initial phases of the restructuring program will lead to savings of $2.7bn to $3.1bn a year by 2012. In total, Merck is targeting savings of $3.5bn a year.
Brazilian generics manufacturer Eurofarma has acquired Uruguay counterpart Laboratorios Gautier, further expanding its reach across Latin America.
The deal adds Montivideo-headquartered Gautier’s facilities in Uruguay, Paraguay and Bolivia to Eurofarma’s expanding production chain which, it claims, covers 95 per cent of markets in the region.
The capacity expansion fits with a growth strategy of producing low cost generic products in large population centers that saw revenues increase some 22 per cent last year.
Eurofarma’s expansion across Latin America began in 2009 when it completed the acquisition of a controlling 95 per cent stake in Argentinean drugmaker Quesada Farmaceutica.
The Brazilian firm intends to make further purchases with director of new business, Maria del Pilar Munoz, confirming that it was in talks with companies in Uruguay, Paraguay and Colombia.
Eurofarma’s regional ambitions are also a reflection of the increasingly competitive nature of the generics market in its home territory.
According to a recent RNCOS survey non-branded pharmaceutical sales in Brazil are already worth $1bn a year, equivalent to 10 per cent of the country’s total pharmaceutical market, and are expanding some 38 per cent a year.
However, despite this high level of demand competition is fierce with Eurofarma battling it out with EMS Sigma Pharma and Ache Pharmaceutical Laboratories for dominance of the country’s market.
And, while domestic competition may be reason enough for Eurofarma to seek to grow its business outside the country, the arrival of increasing numbers of foreign suppliers in the attractive Brazilian market may yet emerge as a bigger motivation.
In August last year, the government said that it will provide more incentives to encourage foreign drug companies to set up operations or partnerships in the country.
This has already seen India’s Ranbaxy and Dr Reddy’s have ramped up their efforts in Brazil. More recently the acquisition of Medley by Sanofi-Aventis also suggests the balance of power in the county’s market is changing.
Quintiles is establishing its first Prime Site in Asia by entering into a strategic alliance with the University Malaya Medical Centre (UMMC) in Malaysia.
Partnering with UMMC continues the expansion of the Prime Site concept. Quintiles launched the initiative to improve trial efficiencies by establishing strong links to large clinical research institutions at a number of locations.
Having set up Prime Sites in the US, Europe and Africa, Quintiles has now turned its attention to Asia. UMMC, located in Kuala Lumpur, Malaysia, is partnering with Quintiles on the first Prime Site in Asia.
Anand Tharmaratnam, head of clinical development for Quintiles Asia Pacific, said the commitment of Malaysia’s “government, academic and private industry leaders to promoting leading-edge clinical research in the country is undeniable”.
This has helped make Malaysia “an increasingly important player in Asia Pacific clinical drug development”, said Tharmaratnam. Malaysia also benefits from a skilled clinical workforce, strong research infrastructure and large potential patient populations.
Quintiles first established an office in Asia Pacific in 1993. It now has 20 offices in 14 countries in the region and has conducted more than 1,300 studies. Quintiles views establishing a Prime Site in the region as a “key step” towards delivering on the drug development potential of Asia Pacific.
Tapping into Malaysia’s patient population will help Quintiles meet one of the goals of the Prime Site program, namely boosting recruitment rates. Other Prime Site goals include improving efficiencies, for instance in administrative processes, and strengthening relationships with staff.
UMMC will work alongside Quintiles to improve “the efficacy, productivity and quality of clinical research” conducted at the site, said Ikram Shah bin Ismail, director of UMMC.
Quintiles launched the first Prime Site in London, UK in 2007 and since then has added sites in the US and South Africa. Further expansion has been discussed, with Quintiles saying on several occasions that it is considering setting up in Latin America and Central and Eastern Europe.
Synexus is expanding its capacity and resources in Poland with a new research centre in Gdynia that will be fully operational by the end of the year.
The unit will increase capacity from one hundred to three hundred square meters (3,228 sq. ft.) and will enable the firm to hire additional four full time investigators.
Dr. Radoslow Janiak, Synexus’ Poland manager explained that: “We are able to recruit the right number of patients within the right time frame and that’s exactly what sponsors are looking for.
“We are seeing considerable interest from a number of leading pharmas and CROs who are keen on the developments we have underway to increase our capacity here” continued Janiak.
Synexus’ CEO Michael Fort echoed these thoughts, commenting that “We are continuing to see increased levels of interest for clinical trials throughout the CEE, not least in Poland where our sites are very well located.”
“The pharma companies and CROs we are talking to continue to express their enthusiasm for increased capacity across the CEE and we are keen to help meet their demands.”
Synexus has operated in the country since 2006, with its first site in Wroclaw. It expanded operations in 2009 with the acquisition of three research centers in Warsaw, Gdynia and Katowice.
With a population of more than 300 million, Central and Eastern Europe (CEE) offers great opportunities for the clinical trials industry, which has grown considerably in the region in recent years.
Synexus, for example, in addition to its sites in Poland, has facilities in Bulgaria, Hungary, Austria and Ukraine and recently acquired Clinpharm to further expand its reach.
The consensus opinion is that recruiting in these countries is a more rapid process than elsewhere and the patient population is treatment naïve. These factors, together with the growing number of qualified professional trial staff, make the CEE an attractive region for research.
Axxess Pharma, Inc., a pharmaceutical company specializing in the marketing and distribution of both prescription and non-prescription medical products has announced that their Ontario and Vancouver manufacturing locations and facilities are now operating in full force following the successful 3 year annual inspection by Health Canada.
This successful inspection comes following Axxess Pharma's most recent Letter of Intent (LOI) to acquire a Canada-based pharmaceutical manufacturer. This location generates over $2 million in annual revenues to Axxess Pharma, Inc.'s financials.
The company's facility is roughly 22,000 square feet and manufactures pharmaceuticals, neutroceuticals and dermatologicals. Axxess Pharma will continue the distribution of its own line of pharmaceuticals from its Markham location.
"We are very excited to receive approval from Health Canada. Our facilities are now in place to process and manufacture all orders worldwide. In recent months we have signed exclusive license agreements in Latin America, Africa, Middle East and Canada with non-exclusive sales in the United States and various other countries," stated Gerald Sequeira, President/CEO. "This is one more sign that we are focused on continuing to expand our operations across Canada and gain market share," stated Sequeira.
Pfizer Inc., the world's biggest drugmaker, said it invested $100 million in the expansion of its Singapore plant that makes nutritional products for infants and children.
The New York company said the expansion increased the plant's production capacity by 50 percent. That helps it serve several Asian countries, including China, Indonesia, Thailand, Taiwan and Vietnam.
The plant was a Wyeth operation acquired in Pfizer's purchase of Wyeth last fall.
The expansion of the plant, which is now part of Pfizer Global Manufacturing's Nutrition Operating Unit, brings the total investment in the facility to $372 million.
Guala Closures Group has said its takeover of Bulgarian company Danik had been carried out as part of its expansion strategy in Central and Eastern Europe (CEE).
The Italy-based company, which produces non-refillable closure for the international spirits sector, said the acquisition of Danik was completed in May. No financial details were disclosed.
The Bulgarian outfit, which manufactures non-refillable inserts, closures and injection moulds for the wine, vodka and brandy segments, has an annual turnover approaching €16m and employs around 200 staff.
A Guala spokeswoman said that it was unlikely that it would need to pump new investment into Danik as the plant and machinery were modern and efficient. While the deal would result in the company rationalizing some product lines in Europe, no plant closures were foreseen. No further takeovers had been earmarked for Eastern Europe in the near future, she added.
The Danik acquisition follows the purchase in 2009 of Technologia Closures, in Ukraine, which Guala described as one of the “leading producers in Eastern Europe of polymer and aluminum closures”. The business, renamed Guala Closures Ukraine, is located in Sumy on the Russian border. Guala said its strategic position provides good access to the Russian and other Eastern European markets.
Guala Closures Group CEO, Marco Giovannini said: "Following our acquisition of Technologia in Ukraine last year, the strategic acquisition of Danik will allow us to further strengthen our ability to supply in the most efficient way our Eastern European customers in countries such as Russia and Armenia, as well as the growing spirits market in Mongolia."
The rapidly evolving Asian drug manufacturing sector represents both an opportunity and a challenge for the fine chemicals and molecules industry, according to SAFC president Gilles Cottier.
Cottier set out the plan for Asia explaining, that having built its sales and distribution network, “What we need to do [now] is selectively increase of manufacturing footprint.”
However, while capacity expansion in the region is clearly on the SAFC agenda, the firm’s market strategy will be to compete with local manufacturers on product quality rather than just on price.
Cottier explained that: “[Although] we want to be cost competitive to ensure we are not priced out of the market…our differentiation will not be price driven because I don’t think we will be able to win.”
He went on to say that companies which fail to recognize the need to emphasize the quality of their products as a differentiation strategy are likely to struggle in the region’s ultracompetitive marketplace.
Rather than dwelling on the threat of lower cost competition, SAFC is instead focusing on the market opportunities available in Asia, particularly the emergence of new consumers for its products and services.
Cottier said that: “We’ve seen double digit growth in these markets for the last ten years and [we believe] they are going to grow even faster” citing the rapid growth of the Chinese and Indian pharmaceutical markets’ as examples.
This rate of expansion, he continued, presents tremendous opportunities for SAFC’s life science research businesses as Parma players seek to develop more products for these growing markets.
The other main benefit that Cottier sees with the growth of the drug sector in Asia is the material sourcing opportunities suppliers in the region provide.
“We need to take advantage of the [low] cost base in these countries and that’s why, over the past five years, SAFC has developed teams dedicated to sourcing services and products in Asia, particularly in India and China..”
Brazilian generics manufacturer Eurofarma has acquired Uruguay counterpart Laboratorios Gautier, further expanding its reach across Latin America.
The deal adds Montivideo-headquartered Gautier’s facilities in Uruguay, Paraguay and Bolivia to Eurofarma’s expanding production chain which, it claims, covers 95 per cent of markets in the region.
The capacity expansion fits with a growth strategy of producing low cost generic products in large population centers that saw revenues increase some 22 per cent last year.
Eurofarma’s expansion across Latin America began in 2009 when it completed the acquisition of a controlling 95 per cent stake in Argentinean drugmaker Quesada Farmaceutica.
More recently the Brazilian firm intends to make further purchases with director of new business, Maria del Pilar Munoz, confirming that it was in talks with companies in Uruguay, Paraguay and Colombia.
Eurofarma’s regional ambitions are also a reflection of the increasingly competitive nature of the generics market in its home territory.
According to a recent RNCOS survey non-branded pharmaceutical sales in Brazil are already worth $1bn a year, equivalent to 10 per cent of the country’s total pharmaceutical market, and are expanding some 38 per cent a year. However, despite this high level of demand competition is fierce with Eurofarma battling it out with EMS Sigma Pharma and Ache Pharmaceutical Laboratories for dominance of the country’s market.
And, while domestic competition may be reason enough for Eurofarma to seek to grow its business outside the country, the arrival of increasing numbers of foreign suppliers in the attractive Brazilian market may yet emerge as a bigger motivation.
In August last year, the government said that it will provide more incentives to encourage foreign drug companies to set up operations or partnerships in the country.
This has already seen India’s Ranbaxy and Dr. Reddy’s have ramped up their efforts in Brazil. More recently the acquisition of Medley by Sanofi-Aventis also suggests the balance of power in the county’s market is changing.
NextPharma has added a new bottle filling line for tablets at its Göttingen facility in Germany. The 45-meter ‘U-Form’ line is constructed with a separate primary area for filling and sealing and secondary area for labeling and packaging. This new addition also meets GMP/FDA standards.
This line was designed to serve the U.S. market and can fill different forms of tablets, capsules and coated tablets into various forms and sizes of plastic and glass bottles. Currently, the line is set up to provide six bottling formats with the capability to add other formats as needed. Round or square bottles can be bundled or packed directly into boxes on the line and can be sealed with screw caps or press-on caps with tamper proof or childproof sealings. The labeling unit can also provide a number of different formats including a printed Data-Matrix Code.
Bill Wedlake, chief executive officer of NextPharma added “The refurbishment of this facility to provide a center of excellence for the manufacture and packaging of solid dosage forms has been a key priority for NextPharma and I’m delighted that the process is now complete following the arrival of this new bottle filling line. We are excited at the prospect of also serving the U.S. market in this area of contract manufacturing and meeting our customers’ requirements through our expanded capabilities in this excellent facility.”
GlaxoSmithKline (GSK) and Aptuit, Inc. announced that they have finalized an agreement for Aptuit to acquire operations at GSK’s Medicines Research Centre in Verona, Italy. The arrangement, which is effective as of July 1, 2010, provides for ongoing employment of the staff at the center and for Aptuit to supply GSK with R&D services from the facilities. Financial terms have not been disclosed.
Under the agreement, Aptuit will gain the scientific expertise and knowledge at the research centre through the transfer of the facility’s approximately 500 staff from GSK to Aptuit. This will help maintain the life sciences research and talent pool in Italy. In addition to becoming an important member of GSK’s contract research organization network, acquisition of the operations will also allow Aptuit to provide integrated development services to its global customers.
“Aptuit was built to provide an integrated drug development capability and streamline the drug development process. This is a strategic acquisition of GSK’s research business in Verona that further strengthens scientific expertise and capabilities within Aptuit, extending our integrated discovery and development offerings,” said Tim Tyson, Chairman and CEO of Aptuit. “This partnership is an example of the developing new model of outsourced R&D collaborations. Verona staff are recognized industry-wide for their drug development expertise and will be an excellent addition to the Aptuit team.”
GSK announced in February its proposal to cease discovery research in select neurosciences areas such as pain and depression, which impacted research at the Italian facility.
Moncef Slaoui, Chairman of GSK Research and Development said, “I am pleased that both GSK and Aptuit have developed this innovative approach. It provides a modern option for drug discovery expertise to remain as part of the science research community in Italy and offers the opportunity to assure continuity of employment for the GSK staff at the site. This arrangement would not have been possible without the input of the Italian government and unions.”
The Verona Medicines Research Centre expands Aptuit’s global footprint to 19 locations – a global network of operations that provides a full suite of development services. The agreement also enhances Aptuit’s ability to serve customers working to develop compounds for high-value and strategically important therapeutic areas such as neurosciences discovery and development, as well as cardiovascular and infectious diseases.
Aptuit will combine its existing capabilities with the Verona Medicines Research Centre’s expertise in drug discovery, lead optimization, active pharmaceutical ingredient (API) development and manufacturing, and pre-clinical and clinical drug development. This will create a unique, industry-leading drug development capability.
Japan's Okinawa Institute of Science and Technology said it plans to start construction later this year on its second of three laboratory buildings planned for its permanent Onna-son main campus.
"The construction of Laboratory 2 is scheduled to commence in September, after which the construction of Laboratory 3 will begin as determined by the progress of PI recruitment," said Kaoru Natori, a spokesperson for the institute.
Natori was referring to earlier-announced plans by OIST to fill about 15 new faculty positions as it pursues accreditation as an independent university, and prepares to welcome its first class of graduate students in September 2012.
The second phase of construction is set to begin six months after the March completion of the institute's first phase, which consisted of a hub building and the first lab building. When all three phases are completed, the campus will house 700,000 square feet of lab buildings, part of a total 2.5 million square feet of construction planned for OIST's 550 acres.
OIST has launched 23 research groups in four major areas — neuroscience, molecular sciences, mathematical and computational biology, as well as marine ecological science. As of April, the institute had more than 170 researchers, and more than 70 administrative staffers whose positions support the researchers.
The institute is led by Founding President and First President Sydney Brenner, a co-winner of the 2002 Nobel Prize for physiology or medicine, for research that identified key genes regulating organ development and programmed cell death in worms. He also helped discover messenger RNA.
For the current fiscal year, which began April 1, OIST has budgeted more than ¥9.9 billion ($113.3 million) in construction expenses — ¥7.7 billion in facilities subsidies from the Japanese national government, and another ¥2.2 million from its government subsidy for operations. The facilities funds include ¥2.6 million carried over from last year.
The first construction phase was completed at a cost of ¥17.6 billion, Natori said. In 2005, OIST's governing board anticipated spending a total ¥19.4 billion through March 31, 2009, for campus construction under its first "Medium-Term Plan."
The institute's budget, mostly subsidized by the national government, has risen steadily since the initial ¥5 billion in 2005, to almost ¥11.3 billion in 2009, and to nearly ¥16 billion in the current fiscal year.
For the current fiscal year, the Japanese government raised the operating subsidy almost 44 percent, or about ¥2.5 billion from FY 2009, to the current ¥8.2 billion. The increase will enable OIST to hire the 15 new faculty members as planned, Natori said.
Rising costs of construction and operations prompted the corporation to issue a statement last March declaring that it had put into place "a number of management changes that the Board strongly supports and is confident that these will be effective in avoiding such problems in the future."
"While there have been major challenges in the timely construction of these complex facilities, which are critical for the success in attracting the best students and researchers in the world, it is nonetheless essential that appropriate fiscal procedures should have been followed," the institute's governing board stated.
The statement came even as OIST defended what Nature magazine disclosed as its spending ¥36 million for its board, including travel costs and honoraria related to their attending meetings.
Since then, Natori said, OIST has carried out changes in procedures to contain costs. "They include improvement in sharing information between the research side and the administration, an increase [in] the number of budget staff members with expertise, and the establishment of a budget study committee related to the facility design."
In addition, the institute "has made progress in the recruitment of a Chief Administrative Officer with extensive experience in the management of public entities," Natori added.
"We are reducing expenditures by cost-effective administration, sharing of research equipment, and bulk purchase of supplies. We believe these efforts do not affect our research and education activities, but rather are beneficial for our future development," Natori added.
Sanofi-Aventis will build a new manufacturing plant in King Abdullah Economic City (KAEC) in Saudi Arabia through an agreement with the Emaar development company (ECC).
The 35,000 sqm (376,600 sq. ft.) facility will produce oral anti-diabetics and cardiovascular drugs for the local market, which is estimated to be worth over $400m (€328m) a year according to a recent Zawya survey.
Sanofi’s decision to locate the plant in KAEC is a big win for the ECC and the Saudi Arabian General Investment Authority (SAGIA) who have been actively courting investment from the global drug industry.
This point was stressed by ECC managing director Fahd Al Rasheed, who explained that: “We have given special attention to the pharmaceutical sector primarily because of the quality of jobs they create and the products they produce which contribute to the well being of Saudi citizens.”
Manar Al-Moneef, SAGIA director general of health and life sciences agreed, suggesting Sanofi-Aventis' move “solidifies the city's position as …an ideal regional hub for partaking in the booming Middle East emerging market."
Sanofi’s move, which fits with the general trend for Big Pharma firm’s to invest in emerging pharmaceutical markets, is unlikely to be its last deal in the region according to company senior VP Antoine Ortoli.
He explained that: “We are looking for all public and private partnerships across the Middle East that will open doors to new solutions for better health outcomes and strengthen our leadership position in those fast growing Markets.”
GlaxoSmithKline (GSK) and Aptuit, Inc. announced that they have finalized an agreement for Aptuit to acquire operations at GSK’s Medicines Research Centre in Verona, Italy. The arrangement, which is effective as of July 1, 2010, provides for ongoing employment of the staff at the centre and for Aptuit to supply GSK with R&D services from the facilities. Financial terms have not been disclosed.
Under the agreement, Aptuit will gain the scientific expertise and knowledge at the research centre through the transfer of the facility’s approximately 500 staff from GSK to Aptuit. This will help maintain the life sciences research and talent pool in Italy. In addition to becoming an important member of GSK’s contract research organization network acquisition of the operations will also allow Aptuit to provide integrated development services to its global customers.
"Aptuit was built to provide an integrated drug development capability and streamline the drug development process. This is a strategic acquisition of GSK's research business in Verona that further strengthens scientific expertise and capabilities within Aptuit, extending our integrated discovery and development offerings," said Tim Tyson, chairman and CEO of Aptuit.
"This partnership is an example of the developing new model of outsourced R&D collaborations. Verona staff are recognized industry-wide for their drug development expertise and will be an excellent addition to the Aptuit team."
GSK announced in February its proposal to cease discovery research in select neurosciences areas such as pain and depression, which impacted research at the Italian facility.
Moncef Slaoui, chairman of GSK research and development said: "I am pleased that both GSK and Aptuit have developed this innovative approach. It provides a modern option for drug discovery expertise to remain as part of the science research community in Italy and offers the opportunity to assure continuity of employment for the GSK staff at the site. This arrangement would not have been possible without the input of the Italian government and unions."
The Verona Medicines Research Centre expands Aptuit's global footprint to 19 locations--a global network of operations that provides a full suite of development services. The agreement also enhances Aptuit’s ability to serve customers working to develop compounds for high-value and strategically important therapeutic areas such as neurosciences discovery and development, as well as cardiovascular and infectious diseases. Aptuit will combine its existing capabilities with the Verona Medicines Research Centre’s expertise in drug discovery, lead optimization, active pharmaceutical ingredient (API) development and manufacturing, and pre-clinical and clinical drug development. This will create a unique, industry-leading drug development capability.
Aptuit, Inc. is a global pharmaceutical services company focused on delivering contract development and manufacturing services and streamlining the drug development process for biotechnology and pharmaceutical innovators. Aptuit’s employees deliver an integrated suite of product development services to more than 800 companies worldwide, driven by a deep commitment to client service, quality, and an unrivaled track record of scientific excellence. The company is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.
GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Almac's new North American headquarters facility will feature a 271,000 cubic-foot cold storage unit to accommodate clinical supplies, in particular biologics, which have to be stored at cold temperatures.
The cold storage facility will be equipped with four separate temperature zones, two for drugs requiring refrigeration and two for drugs requiring colder temperatures. The zones range from 77°F to -112°F. The building is also equipped with vault storage for controlled substances.
“Much of the recent demand has been for biologics,” said Dave Setley, head of business development at Almac. “By expanding our cold storage capabilities, Almac is meeting the needs of our clients more efficiently and helping to bring popular pharmaceuticals to market faster.”
The company has also increased its cold storage capacity at its world headquarters in Northern Ireland, adding 150,000 cubic feet.
Saltigo GmbH has passed an FDA audit at its Leverkusen site. The audit focused on testing production and quality assurance processes for an active ingredient a client plans to supply in the U.S. As part of the pre-approval inspection, the FDA determines if a medical product can be manufactured at the company’s production facilities using technology recognized in the U.S. as state-of-the-art and in compliance with cGMP.
Saltigo’s managing director Wolfgang Schmitz commented, “The FDA audit is an internationally accredited seal of quality and recognizes all the work we have put in. This shows not just U.S. customers but also pharmaceutical companies throughout the world that with us the production of active ingredients is in safe and reliable hands.”
CRO Icon has opened a 3,000 sq ft central laboratory in Tianjin, China in partnership with Fountain Medical Development (FMD).
Icon now operates three central laboratories in Asia Pacific, with the Tianjin site joining existing facilities in Bangalore, India and Singapore. Establishing a central laboratory in China will bring the contract research organization (CRO) closer to its clients operating in the country.
The laboratory is located 70 miles outside of Beijing. Locating near to Beijing, an accessible city, will allow Icon to serve clients throughout China. Benefits of this include shorter shipping distances between clinical sites and testing facilities which can accelerate study completion.
Icon has partnered with FMD to support the project. FMD is supporting Icon with local knowledge and experience to help it provide “a faster and more cost efficient service”, said Dan Zheng, CEO of FMD.
In return, FMD will benefit from having access to the resources, systems and infrastructure possessed by Icon, said Zheng.
The facility will offer testing services covering chemistry, coagulation, haematology, immunology and other areas to meet study-specific requirements. Accreditation by the College of American Pathologists (CAP) was received last month.
Technical Resources International (TRI) and its subcontractor, Icon, have been awarded the clinical research operations and management support (CROMS) contract by the National Institute of Allergy and Infectious Diseases (NIAID).
Under the terms of the contract, TRI and Icon will support the division of microbiology and infectious diseases (DMID) at the NIAID. Support covers areas including protocol development, clinical site monitoring, training, pharmacovigilance, and the CROMS information data system.
DMID supports extramural research including Phase I to IV trials into virtually all human infectious diseases, except HIV.
An initial award of $19m (€15m) has been made for the contract. Over the next seven years the contract could rise to a total value of $171m.
Millipore Corporation has moved its European BioPharma Services unit to new, expanded facilities to accommodate strong growth in the biotechnology sector. The new facilities are located in Milton Park, near Didcot in Oxfordshire, England.
Millipore’s BioPharma Services unit is the first global contract research organization (CRO) dedicated exclusively to large molecule bioanalytical work. The unit arose from Millipore’s acquisition in August, 2009 of BioAnaLab, which specializes in the analysis of biopharmaceuticals and has been supporting drug development for the pharmaceutical industry for the past several years.
Geoff Hale, Managing Director of BioAnaLab said: "The new laboratory provides us with space to continue our growth as we expand the range of services we provide.” Craig Morley, Global Managing Director of Millipore’s BioPharma Services added: ""The new facility complements the outstanding facilities at our St. Charles site and is a significant milestone in our development as "The World's Large Molecule Lab."
Abbott aims to become India’s leading pharmaceutical company through the $3.72 billion cash acquisition of Mumbai-based Piramal Healthcare’s generics business. The deal includes a $2.12 billion up-front payment and four $400 million annual payments starting in 2011.
Piramal’s Healthcare Solutions business specializes in Indian branded generics. It is expected to make sales of over $500 million in India next year. The business experienced 23% growth in the fiscal year ending March 31, 2010.
Abbott says it will integrate the operation into its newly created, standalone Established Products division. The division was formally announced when Abbott also reported on a licensing and supply agreement with India’s Zydus Cadila for a portfolio of 24 pharmaceuticals, which it will commercialize in 15 emerging markets.
Piramal suggests that the combination of its branded generics business with Abbott’s existing operations means the latter will take the number one slot in India with a 7% market share. Abbott says that it hopes its combined Indian pharmaceuticals business will achieve growth of about 20% annually and potentially reach sales of over $2.5 billion by 2020.
“This strategic action will advance Abbott into the leading market position in India,” says Miles D. White, Abbott chairman and CEO. “Emerging markets represent one of the greatest opportunities in healthcare, not only in pharmaceuticals but across our business segments. Today emerging markets represent more than twenty percent of Abbott’s total business.”
The company claims branded generics account for some 25% of the global pharmaceutical market and corner the lion’s share of the largest emerging markets. They are also expected to overtake the growth of patented and generic products. Abbott suggests the branded generics market in India is a key factor in the country’s standing as one of the fastest-growing pharmaceutical markets worldwide. The country currently generates about $8 billion worth of pharmaceutical sales annually, a figure that is expected to double by 2015.
Hungary-based Ubichem Research has gained approval to supply cGMP radiolabelled APIs in the European Union (EU), positioning it to benefit from increased demand.
The rise of microdosing has increased interest in radiolabelled compounds, prompting companies including PerkinElmer to bolster capabilities. Ubichem gained radiochemical capabilities through an acquisition in 2007 and since then has worked to enhance its offering.
József Répási, managing director of Ubichem, said that the latest step in these efforts has been the expansion of current good manufacturing practices (cGMP) to the radiolabelling laboratories.
Equipment has been upgraded and installed to give the Ubichem isotope sysnethis group, which has extensive experience working with radiolabelled compounds, a site that is in compliance with cGMP.
Having taken these steps Ubichem had the site inspected by Hungarian authorities for the production of radiolabelled cGMP active pharmaceutical ingredients (API). Répási commented that the site has also been successfully audited by a client.
An agreement between the Hungarian authorities and the EU means the approval allows Ubichem to supply the European market. Répási said that there has been a definite increase in demand for radiolabelled APIs and Ubichem is now well equipped to serve this growth market.
The shelf-life of radiolabelled APIs poses difficulties for shipping. To overcome these challenges Ubichem has outsourced shipping to a specialist company with more than 20 years of experience in the radiochemistry sector.
Répási explained that packaging compliant with API and radiolabelling guidelines is used. The radiolabelled APIs are then in shipped in dry ice at -78ºC to maximize shelf life.
Ubichem has sought to ship radiolabelled APIs to the US but the compounds’ shelf-life has limited penetration into the lucrative market, added Répási. Also, there is significant competition from US-based radiolabelled API producers. Japan also represents an opportunity.
Ubichem was founded in 1978 to offer competitive sourcing solutions for fine chemicals and intermediates to clients in high-technology industries, and these activities continue today through the Fine Chemicals Division.
Ubichem Research was created in 1996 in Budapest, Hungary, and through the Pharma Services Division, provides a comprehensive range of chemistry services (on lab to pilot plant scale) to support early pharmaceutical development. These include cGMP API and intermediate manufacture, process research and development, analytical method development and validation, and radiolabelling.
Baxter Healthcare is expanding its European R&D presence with a new facility designed to take new pharmaceuticals from “conception to registration.”
The unit, in Alliance Park Braine l'Alleud, south of Brussels, Belgium, will act as Baxter’s hub for development of recombinant, plasma-based therapeutics, vaccines, packaging and delivery systems and peritoneal dialysis devices.
Baxter has operated in Belgium for fifty years, previously basing its R&D operations in Nivelles and the capital Brussels. However, according to company vice president Ludwig Hantson, the new unit offers a number of advantages.
“Alliance Park provides a critical step forward in Baxter's future by aligning multiple functions in one area, thereby encouraging more ideas to develop into solutions that serve healthcare professionals and patients."
Baxter Healthcare has moved its R&D, including commercial and administrative offices, to Parc de l'Alliance (Alliance Park), Braine l'Alleud, based south of Brussels, Belgium. One of three R&D facilities in Europe, Alliance Park represents a major milestone for Baxter operations in Belgiu
The facility merges two organizations located previously in Brussels and in Nivelles and houses 430 employees currently. The location is unique in that its activities cover all stages of a product's life cycle from conception to registration. In this facility, the organization will further increase efficiency and effectiveness in the early phases of bringing new therapies to the market.
"Baxter has a rich history in Belgium having opened the first offices outside the U.S. in 1954 and the first plant in Lessines in 1970. Alliance Park provides a critical step forward in Baxter's future by aligning multiple functions in one area, thereby encouraging more ideas to develop into solutions that serve healthcare professionals and patients," said Baxter Corporate VP and President, International Ludwig Hantson.
The new R&D location in Alliance Park will provide Baxter Europe, Middle East and Africa (EMEA) with a R&D infrastructure that will meet upcoming demands for product development and registration. To remain competitive with leading technological innovation, Baxter Alliance Park teams also conduct joint research with leading European research universities and organizations in Belgium as well as in Lille and Paris, France.
"With a goal of providing solutions to hospitals, doctors, healthcare providers and patients, the R&D organization is vital to advancing Baxter's current technologies and developing new innovations. Currently, Baxter is advancing clinical trials and numerous early-stage programs that have the potential to profoundly impact the treatment and delivery of care for chronic diseases, like Alzheimer's disease, hemophilia, end-stage renal disease, immune deficiencies, as well as public health threats like pandemic and seasonal influenza," said General Manager of Baxter Belgium Jo Benoit.
Researchers at Baxter Alliance Park concentrate on the development of new technologies and projects, including solutions for Peritoneal Dialysis, recombinant and plasma-based therapeutics, vaccines, initiatives in regenerative medicine, parenteral nutrition, and enhanced packaging systems for the company's Medication Delivery and BioScience global business units.
Pharmaceutical and healthcare carton specialists, Chesapeake has formed an alliance with carton supplier Cartonajes Leca in a move that aims to extend its production network to southern Europe.
The partnership secured by the healthcare packaging firm forms part of an overall business strategy in which its presence in France, Germany, Belgium, Poland and Holland will now be backed up with a commercial agreement with Spanish-based Leca.
Under the terms of the agreement, Leca will become the representative of both companies in Spain and will become a local source of supply. Chesapeake said the alliance was established for purely commercial reasons only and did not involve ownership or exchange of shares or investment interest.
Leca, part of the Lantero Group, produces a selection of folding cartons for the pharmaceutical and healthcare market. It currently has three production sites, two operations in Madrid and a plant in Barcelona.
“Leca is a well-respected packaging supplier and an ideal partner to further extend our presence in Southern Europe,” said Mike Cheetham, pharmaceutical and healthcare director. “This trading alliance will enhance our service to customers allowing both parties to offer a greater range of products and to jointly develop new solutions.”
Ramon Lantero, Leca’s Chief Executive Officer, said, “This alliance will strengthen our service to customers and will provide mutual opportunities for further developments.”
News of Chesapeake’s latest partnership echoes movements made by fellow pharmaceutical and healthcare packaging specialists Clondalkin Group.
Its Specialist Packaging Division now has eight European manufacturing sites in total boosted by its raft of acquisitions during the past three years. As well as the purchase of Cartonplex in Spain, January 2010 saw Lehigh Press, a Puerto-Rican pharmaceutical inserts and labels manufacturer come on board.
Chesapeake has adopted an approach in which investment is central to developing and further extending its integrated supply network.
Its acquisition of Polish label and carton manufacturer Cezar signified Chesapeake’s return to form after it was acquired by Irving Place Capital Management and Oaktree Capital Management in May 2009.
The U.S.-based private equity houses stumped up $485m for the carton and plastic packaging group, four months after Chesapeake's fall into chapter 11 bankruptcy protection in December 2008.
Later on the firm invested in a GUK folding machine and a KBA press at its Greenford site to up production numbers for its pharmaceutical leaflets.
It also formed an international alliance in May by forming a partnership with Papcart, a Nantes-based supplier of premium cartons.
Chesapeake already has a significant presence in France operating four production plants of which three specialize in packaging for the pharmaceutical and healthcare sectors.
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