PHARMACEUTICAL AND BIOTECHNOLOGY
UPDATE
February 2008
McIlvaine Company
TABLE OF CONTENTS
Global Research Services, Quintiles and Icon Expand CRO Ability
Quintiles Expands at Research Hub in North Carolina
University of Missouri Expands Research Center
Pharmaceutical Products Development (PPD) Announced it is Moving into Russia
Contract Manufacturing Facility Updates
Pfizer Expands in Inhaled Drugs as Nektar Cuts Back
AMRI builds upon Indian Operations
Stowers Institute Plans $25 Million Expansion
Cambridge Plans a $30 Million Expansion
Wake Tech Awarded Grants to Enhance Programs
MPI Research and Shanghai Medicilon Announce Shanghai-Based Joint Venture
Genmab, the Danish Antibody Specialist, Acquires an Antibody Facility in Minnesota, US for $240 Million
The Brooklyn Park facility, which has a production capacity of 22,000 litres, is being sold by PDL BioPharma. The transaction, which is subject to the normal closing conditions and is expected to be completed by the end of the first quarter, includes land, equipment and access to a leased space housing a development laboratory.
There are also some 170 employees currently working at the facility. Genmab intends to retain these staff and could add another 130-150 to bring the facility up to full capacity.
The plant includes two 1,000 litre and two 10,000 litre
bioreactors that support the simultaneous manufacture of multiple antibody
products. This will enable Genmab to transition three antibodies from research
to manufacturing each year.
Global Research Services, Quintiles and Icon Expand CRO Ability
U.S.-based contract research organization (CRO) Global Research Services has launched a new web-based clinical trial management course in collaboration with the University of Rochester Medical Center.
The training program, titled "Managing Clinical Trials: A Comprehensive Continuing Education Course for Healthcare Professionals", will initially be available to US participants, however the CRO has plans to roll out the course to China by the middle of this year, and to Eastern Europe by the end of the year.
Global Research said that China's increased participation in global drug development and the recent cooperative agreements between China's State Food and Drug Administration (SFDA) and the US Food and Drug Administration (FDA) presents a great opportunity to provide clinical-research training in Asia.
The CRO and its university partner are already in negotiations with three major Chinese medical universities.
Quintiles Expands at Research Hub in North Carolina
Quintiles has revealed that it plans to soon open another office in one of the US' major research hubs, Wilmington, North Carolina.
Already the CRO titan is in the throes of constructing a new headquarters in the state which will see it employ 1,000 new staff; the firm is also opened a new data management centre in the vicinity not so long ago.
Furthermore, Quintiles also recently completed its previously announced new investor partnership, whereby One Equity Partners, the private equity arm of JPMorgan Chase sold its stake in the firm and CEO Dennis Gillings, CBE, and other members of the management team have taken over as lead investors.
Ireland's Icon has forged a new collaboration agreement with the UK-based Medicines Evaluation Unit (MEU), allowing it access to an 18-bed hospital-based early phase research facility on the Wythenshawe Hospital site in Manchester.
The CRO already runs an 80 bed clinical research unit in Manchester, although it is not hospital-based.
Having a hospital-based clinical research facility is a significant bonus when conducting early phase studies, especially first-in-man trials, as it means that patients are within minutes of emergency care should any adverse reaction occur.
University of Missouri Expands Research Center
A planned Learning and Discovery Park could draw more biotechnology work to the University of Missouri Greenley Research Center near Novelty.
The facility will offer a $2 million lab and a separate conference center.
Project funding came through Blunt's Lewis and Clark Discovery Initiative, designed to transform the Missouri Higher Education Loan Authority into a public-private partnership to generate $425 million for higher education institutions across the state.
Construction should begin in the spring on the two new buildings just east and south of existing facilities on the 700-acre farm near Novelty.
The first building will house a lab, along with chemical handling and storage areas and storage for some machinery and instruments. The lab will be designed for staff and researchers with limited public access.
A second structure is planned as a meeting/conference facility to accommodate up to 200 people. That building will be used by the university, University of Missouri Extension and the public.
Construction should be finished by late fall or early winter. Additional fundraising could be needed to complete the conference facility.
The state also funded a new facility in Mexico designed as a joint effort between the university and private industry to look at new technology tied to cellulose.
The center works to evaluate efficient, profitable crop production in northern Missouri while emphasizing soil conservation, water quality and energy efficiency. Researchers study the benefits of reduced tillage, alternative cropping practices, the effects of new technology and products, variety testing, soil fertility and beef cattle management.
Pharmaceutical Products Development (PPD) Announced it is Moving into Russia
The contract research organization (CRO) is intending to buy InnoPharm, another CRO based in Smolensk, Russia, which also has offices in Moscow and St Petersburg and a staff of 300.
The acquisition of InnoPharm, which offers Phase II-IV clinical trials, data management and biostatistics services, will not only provide PPD with a foothold in the vast clinical territory of Russia, but also in neighboring Ukraine, where it has an office in Kiev.
With more than 143m people in Russia alone, Eastern Europe is a high-growth market for clinical trials and a region PPD has targeted for expansion.
PPD has subcontracted work to InnoPharm since 2004 on a
non-exclusive basis.
Icon Buys U.S. Phase I Base
Ireland's Icon has bought itself a Phase I base in the US with the acquisition of Healthcare Discoveries. The contract research organization (CRO) will pay $12m in cash and if certain performance milestones are achieved in 2008, a further consideration of up to $10m may be payable.
Healthcare Discoveries operates an 85 bed clinical pharmacology unit in San Antonio, Texas, and Icon's CEO Peter Gray said the new US facility will complement its existing European Phase I operations, which include an existing 80 bed clinical pharmacology unit based in Manchester, England.
Only last month, Icon forayed further into Eastern Europe with the opening of three new offices there.
Prague, Czech Republic; Kiev, Ukraine; and Bucharest, Romania are the locations of the company's new facilities, which according to the firm, are located near leading teaching hospitals and national clinical research sites and provide access to investigators and patient groups.
Icon is one of a number of CROs who are spreading their roots further into this region of the world, chasing the promise that it holds.
Meanwhile, last July Icon also made a $40m purchase of
Dutch-based contract staffing firm DOCS International, allowing it to expand
into Europe in this field.
DOCS, which operates in eight European countries, was integrated with Icon's
existing US-based staffing business, Icon Contracting Solutions, to form a
global business unit, with desired effect of providing more global flexibility
for its customers.
Cook Pharmica has announced an $80m expansion to its biopharmaceutical facility in Bloomington, Indiana. The cash injection will add 80,000 sq. ft. to the existing site, and with 200 extra jobs will more than double the existing workforce at the site when the expansion is fully completed.
The development will see Cook return to providing formulation, filling and finishing services to the pharma industry, activities that were carried out by parenteral contract manufacturer Cook Pharmaceutical Solutions until its acquisition by Baxter in 2001.
The existing facility will benefit from the addition of two new filling lines and corresponding finishing lines, with plans including one high-speed syringe filling line and one low-medium speed vial filling line with lyophilisation capacity up to 250 sq. ft. Both lines will be fitted out with isolator technology.
Cook's Bloomington site is currently focused on developing and manufacturing mammalian cell-culture based products, but will now be able to offer formulation, filling and finishing services to customers.
The facility will also move into aseptically filled parenteral vial and syringe products such as simple solutions and diutents, suspensions, vaccines, proteins and biologics.
There is a further 600,000 sq. ft of available space on the campus into which the company can move should it continue to expand.
Through the expansion plans, Cook was offered up to $2.2 million by the Indiana Economic Development Corporation in performance-based tax credits and up to $100,000 in training grants based on the firm's job creation plans.
Construction work on the expansion is due to start in mid-2008, with completion expected in early 2010.
Contract Manufacturing Facility Updates
Several contract manufacturers have recently made announcements regarding updates to their facilities.
Following a $1.5m renovation, AAIPharma's sterile manufacturing plant in South Carolina, US, has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to produce aseptic and lyophilised products.
The US Food and Drug Administration (FDA) has also previously approved the facility and the firm said the additional MHRA approval positions the plant to deliver aseptic contract manufacturing services to clients wishing to supply both commercial and clinical sterile drug products throughout the US and Europe.
On the flipside, Glenmark Pharma has received good manufacturing practice (GMP) approval from the FDA for its semi-solid dosage manufacturing plant at in Himachal Pradesh, India. This plant has also received GMP approval from the UK's Modern Humanities Research Association (MHRA), as are its other formulation manufacturing facilities at Ankleshwar and Goa.
Likewise, biopharmaceutical contract manufacturer Angel Biotechnology has been awarded a manufacturer's and importers authorization (MIA) by the MHRA. This license is a prerequisite for companies wishing to make biopharmaceuticals to sell in the UK.
In other news, Robinson Pharma has announced an upgrade to its soft gel inspection capability to a fully automated process using a Symetix optical inspection system.
In addition, the machine can check for irregularities in color, size, shape, width, symmetry, and surface quality, as well as detect foreign objects or flaws such as twinning and rejects unacceptable individual doses with a jet of air as the product moves through the equipment, the firm said.
Pfizer Expands in Inhaled Drugs as Nektar Cuts Back
Pfizer's announcement of plans to create a new €130m inhaled medicines unit at its facility in Amboise, France.
On February 12, despite having regained full rights to Exubera under a settlement with Pfizer that was finalized in November last year, Nektar announced plans to streamline its operations. The firm said that the program was likely to result in the loss of 150 jobs and a pre-tax severance charge of between $7m and $8m in the current financial year.
The firm added that it still plans to find a new commercial partner for its inhaled insulin program.
In contrast, Pfizer's proposed inhaled drugs unit will create around 440 new jobs and is intended to position the Amboise site as the leading global centre for the development of such products, both in terms of formulation and manufacture. The news will be welcomed by the local workforce, which was informed in February of plans to shut down R&D operations at the facility.
Pfizer said that it intends to begin construction of the new state of the art facility in March this year and anticipates that the project will be complete in approximately five years time.
AMRI builds upon Indian Operations
New York-based AMRI has added to its Indian operations, following the acquisition of another manufacturing plant in the country. The firm has bought Aurangabad-based FineKem Laboratories, for a reported price tag of "less than $2m" and the acquisition is expected to "significantly accelerate" AMRI's ability to make custom pilot scale intermediates in India.
The company already has chemical development process capabilities in Hyderabad, along with manufacturing facilities in Aurangabad and Navi Mumbai, and a company spokesperson said the new facility will help to "build a bridge" between all these facilities.
Production at the new site is expected to commence in the second quarter of 2008 with around 20 employees, although up until this time AMRI said it intends to implement upgrades over the next few months to bring the existing facilities into compliance with US Food and Drug Administration (FDA) regulations for the manufacturing of clinical trial materials and commercial drug substances.
Under the purchase arrangement, FineKem's managing director, Rakesh Doshi, will join AMRI India as executive director and COO, reporting to Dr Prasad Raje, managing director of AMRI's current Aurangabad and Navi Mumbai facilities.
The US-based contract manufacturer has been busily embracing India with the purchase and construction of infrastructure to cement itself in this popular location.
The firm has invested heavily in analytical chemistry services in the country. In October last year it had recently completed construction of new contract research laboratories, moving from a smaller, leased site that it had occupied since 2005.
The new 57,000 square foot facility in Hyderabad now has over 60 staff and focuses on lab scale custom synthesis and non-GMP analytical chemistry for preclinical drug substances and intermediates, as well as a new kilo lab.
The laboratories have also been given GMP status and so preclinical and clinical manufacturing services, such as chromatographic assays, stress degradation and method validation can be performed there.
Meanwhile, in July 2007 the company obtained its two manufacturing facilities in Aurangabad and in Navi Mumbai.
These two facilities currently make active pharmaceutical ingredients (APIs) as well as intermediates for the domestic market, although the firm is looking to convert some capacity over to also making some of the intermediates here that are currently made at its New York facilities, by early this year.
The amount will be spent on different development projects of the university which include construction of building for Veterinary and Animal Sciences department, faculty building for Science departments of Biochemistry, Biotechnology, Biology and Zoology, construction of faculty of Commerce, Computer Sciences and Management Sciences, building for department of Fine Arts, Designing and Performing Arts.
Stowers Institute Plans $25 Million Expansion
The Stowers Institute for Medical Research and a technology development offshoot are moving ahead with a $25 million expansion project in south Kansas City.
A much larger initiative to create a second campus for the institute is still on hold, however, as leaders remain concerned about ongoing attempts to impose restrictions on some forms of stem-cell research in Missouri.
Contention over embryonic stem-cell research regularly emerges when life science topics are debated in Missouri. Some business leaders and legislators have raised concerns that this situation is hindering growth of a promising economic sector in the state.
Stowers leaders specifically cited the issue last year when announcing the delay of expansion planning.
They went ahead, however, with acquiring 100 acres in Kansas City for future laboratory construction that would take place if the stem-cell research uncertainties were resolved.
Advocacy in favor of research coming from officials, including those at the University of Missouri and Washington University, has left Stowers leaders optimistic.
Mutual fund magnate Jim Stowers and his wife, Virginia, who founded the Stowers institute, now have purchased 15 acres and an industrial complex at 8333 Hickman Mills Road in Kansas City. The purchase price was $5 million, and construction costs are estimated at $20 million.
The property is a distribution facility previously operated by Sanofi-Aventis.
Some of the storage and research support functions at the flagship Stowers institute near the Country Club Plaza will be shifted to the 280,000-square-foot complex on the Hickman Mills Road property. The main institute is in need of additional space as it now is home to about 470 workers, including more than 200 doctoral-level scientists.
Also, BioMed Valley Discoveries, a for-profit technology development arm of the institute, will establish its headquarters there.
BioMed Valley is backed by $50 million for its mission of transforming scientific breakthroughs from Stowers or elsewhere into new cures and research tools.
Metrics Inc. has opened its newest analytical lab space. The four new analytical labs add to the company’s capacity for service by 40%. The labs will be fully operational and validated by 2Q 2008.
The addition to Metrics’ existing 44,000-sq.-ft. pharmaceutical development laboratories includes larger scale manufacturing, Phase III to commercial, stability storage, a dedicated lab for cytotoxic and potent compounds, and a microbiology laboratory.
The new lab space is part of an $18 million, 47,000 sq. ft. facility addition that will allow the company to provide both development and commercial manufacturing projects.
The API business specializes in fermented antibiotics, with particular investment over recent years in vancomycin production capacity. The 3i purchase includes the business's five production sites (Oslo, Copenhagen, Budapest, Taiwan and China), which between them currently produce 14 different API products.
The deal is expected to close in the second quarter 2008, with net proceeds to Alpharma of $365m after taxes, fees and expenses. The API division reported operating income of $30.7m for the nine months ending September 2007.
Although Alpharma has been investing in its API business to keep up with the ever-changing environment in the pharmaceutical industry, it was thought to be a wiser decision to sell off the division for a favorable sum now, and focus on the company's pharmaceutical and animal health units.
Cambridge Plans a $30 Million Expansion
Cambridge Major Laboratories (CML) said it is planning to execute a $30m expansion project which will spawn one of most modern active pharmaceutical ingredient (API) manufacturing sites in North America. The new facility will not only allow the firm to expand its current API manufacturing capacity, but will also allow it to offer services further within the clinical development cycle.
Construction will start soon on the new medium scale (up to 3-5 metric tons) manufacturing facility in Germantown, Wisconsin, which is adjacent to its existing 60,000 sq. foot facility in the area, which it will be retained for research and development purposes and will "allow smooth tech transfers" to the new site.
The new site will have a total of 118,000 sq. feet and will comprise of two production halls with a total of seven reactor suites, a warehouse, reactor support facilities, analytical and process R&D kilo labs and corporate offices.
Additionally it will have 18 000 gallons of reactor capacity, including large scale cryogenics and hydrogenation capabilities. Most of the reactors will be 2000 and 1000 gallon scale. Both the existing and new sites will be connected to a common solvent/waste tank farm and thermal oxidizer.
The project will see the addition of 45-50 new employees after its planned completion in mid 2009.
Meanwhile expansion of its U.S. operations is not the only API enhancements that CML has been making of late.
In November last year the company bought up ChemShop, a Dutch supplier of API development services, creating one of the largest pharma chemistry development organizations in the western hemisphere.
The new European addition has been active in the sector for the last nine years, providing process development, contract research and good manufacturing practice (GMP) services to the pharma industry.
Through the deal, CML acquires the company and its 12,500m2
facility in Weert with equipment capable of bench to 450l scale. The facility is
currently kitted out with R&D labs, GMP kilo lab suites and a GMP pilot plant.
CML, however, plans to give ChemShop a makeover, investing "several million
dollars" to expand the firm's site and add reactor capacity, laboratories and
enhance the high potency API manufacturing capabilities at the site. The work
commenced at the time of the announcement and expected to be complete in the
second half of this year.
Wake Tech Awarded Grants to Enhance Programs
Dr. Stephen Scott, president of Wake Technical Community College (Raleigh, NC) reports that the College has received more than $2.5 million in grant funding since May of last year. Grant funds often provide the means for educational and other non-profit organizations to strengthen and expand programs beyond the scope of their regular operating budgets.
Wake Tech encourages collaboration in pursuing innovation and quality enhancement college wide. The Sponsored Programs and Grants Office leverages resources from private, state, and federal funding sources to support Wake Tech's wide variety of new and ongoing projects and initiatives.
Among the grants awarded was $105,104 from the North Carolina Community College System's BioNetwork to Wake Tech's Applied Industrial Biotechnology division. The grant will allow Wake Tech to develop a certificate program in Applied Biotechnology to better meet the needs of employers in the Triangle area, and to improve job placement opportunities for graduates in biotechnology fields. The grant will also enable K-12 teachers to gain knowledge of biotechnology through summer coursework.
The following grants have also been awarded to Wake Tech from the North Carolina Community College System (NCCCS):
Azopharma Product Development Group Acquires Clinical Site, Coastal Medical Research Inc., in Daytona Beach, FL
Azopharma Product Development Group, Inc. announced the acquisition of Coastal Medical Research, Inc. (CMR), a clinical pharmacology facility located in Daytona Beach, FL which will operate under the AvivoClin name. AvivoClin Clinical Services, which was unveiled at the 2007 AAPS Meeting and Exposition, is the clinical pharmacology division of the Azopharma Product Development Group.
The facility will provide phase I-III clinical services across all major therapeutic areas. The CMR facility includes 48 beds and 15,000 sq. ft. of space. Azopharma plans to expand the CMR facility to house over 100 beds. The facility will help by providing services critical to support clinical studies such as formulation, CTM manufacturing, and bioanalytical testing.
Located in Daytona Beach, the facility is strategically located to recruit patients from local universities and colleges. The facility is also strategically placed to recruit specialty patient populations such as senior citizens from the areas many retirement communities.
MPI Research and Shanghai Medicilon Announce Shanghai-Based Joint Venture
MPI Research and Shanghai Medicilon are pleased to announce a new joint venture to form Medicilon-MPI Preclinical Research (Shanghai) LLC. Located initially at the Zhangjiang Hi-Tech Park in Shanghai, China, the company will open a 50,000 sq. ft. preclinical testing facility in the Chuansha Economic Park in early 2008. This new facility will meet the regulatory standards set forth by the US FDA and other regulatory agencies worldwide.
With the joint venture, customers of both parent companies will have the advantage of conducting research at the Shanghai site for preclinical development, with potential for worldwide release. Current and future customers of Medicilon and MPI Research will now have access to a broader range of both GLP and non- GLP preclinical services. By 2009, the new company will be fully operational, in terms of conducting FDA/IND enabling studies, offering additional preclinical support services, submitting INDs and NDAs, and will have AAALAC accreditation.
“With one fourth of the world’s population, China is an important force in shaping the global pharmaceutical and biotechnology markets,” says MPI Research’s Chairman and CEO, William U. Parfet. “We have carefully looked for more than three years to find a CRO partner that shares our values and commitment to excellence, and we have finally found one in Shanghai Medicilon. We look forward to forging a future together as a worldwide leader of preclinical research services.”
Dr. Chun-Lin Chen, co-founder of Medicilon, Inc. as well as Shanghai Medicilon will serve as the CEO of Medicilon-MPI Preclinical Research. Dr Chen is a highly published thought leader in the pharmaceutical industry with extensive experience in academia, pharmaceutical, and regulatory evaluation. Dr. Chen received his PhD from Oklahoma State University, and completed post-doctoral training in the United States. Dr. Chen has held numerous leadership positions in professional scientific trade organizations in China as well as other parts of the world.
A multidisciplinary team of experts originating from MPI Research headquarters will relocate to Shanghai and form a GLP Advisory Board to oversee the US FDA GLP compliance process. This team has a broad range of experience in areas such as small and large animal toxicology, safety pharmacology, pharmacokinetics, animal care, quality assurance, report writing, pathology, and study direction. In partnership with the MPI Research team, over 70 Shanghai Medicilon professionals will be joining the newly formed organization.
Headquartered in Michigan, USA, MPI Research has over 1600 people that provide a comprehensive range of preclinical drug discovery and development research. Known for its quality and timeliness, the company serves the pharmaceutical and biotechnology industries in advancing their drug development programs, from early proof of concept testing to regulatory submissions.
Shanghai Medicilon was founded in 2004 to provide fully integrated drug discovery services to the pharmaceutical and biotechnology industries. Medicilon has been recognized as one of the top drug discovery CROs in China. Located in Shanghai at the Zhangjiang Hi-Tech Park, Medicilon’s 250+ employees provide integrated drug discovery and development services, incorporating medicinal chemistry, lead optimization, custom chemical synthesis, biology services pharmacokinetics, metabolism, and other key services such as, animal toxicology, efficacy and disease model studies.
MPI Research and Medicilon will remain as independent parent companies to the newly formed joint venture.
McIlvaine Company,
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