BIOTECHNOLOGY AND PHARMACEUTICAL

UPDATE

 

April 2009

 

McIlvaine Company

www.mcilvainecompany.com

 

TABLE OF CONTENTS

 

Boston U's National Emerging Infectious Disease Lab Delays Opening

Pfizer Expands Presence in Michigan

Washington University Invests $235 Million to Construct Translational BioMedical Institute

OHSU to Start NIAID Center

Philly's University City Science Center Debuts $1.2M POC Fund for Academic Life-Sci Projects

Pfizer Opens St Louis R&D Centre

ReSearch Buys Chinese CRO

Chinese CRO Has Stake in a Good Laboratory Practice (GLP) Certified Laboratory with China’s Center for Evaluation of Drug Safety at the Second Military Medical University (SMMU) in Shanghai.

U of Cincinnati Lands $22.7M from NCRR

New England Cummings School Dedicates Regional Biosafety Laboratory

Earmark to Help Utah’s Idaho Technology in Identifying Health Hazards

Shire to Shut Owings Mills, Md., Plant, Idling 260; Shifting Work to CRO in NC

Takeda Moves Global Development HQ from Osaka, Japan to Deerfield, IL

Wareham Breaking Ground on Three East Bay Projects Totaling 380,000 Sq. Ft.

Path Commits to Future 111,000 Sq. Ft. Lease at Seattle's 2201 Westlake Project

Fall River, MA Executive Park Wins $17 Million in State Grants; First Tenant Will Be UMass Bioprocessing Facility

Mexico's Silicon Border Sci-Tech Park Completes First Phase of Infrastructure Development.

Component Maker Sapphire Engineering Eyes Move to $9M Middleboro, Mass., Plant

UC Davis' MIND Institute Maps Out $40M Expansion of Sacramento Complex

Doe & Ingalls of North Carolina Celebrates Grand Opening of Riverside, CA Facility

Covaris Extends Lease, Expands to 14K+ Sq. Ft. at Woburn, MA Life-Sci Cluster

With $250K from Maryland, Life Technologies Eyes Adding 50 Workers to Frederick R&D Center, Stem Cell Office

BioMed Realty's Center for Life Science | Boston Achieves LEED Gold Certification

Shasun Chemicals Shuts Pharmaceutical Manufacturing Plant in Scotland

Maryland Senate OKs $6 Million for Biotech Tax Credit Program in FY'10 Budget Bill

Missouri Tax Credit Advocates Say Bill Could Entice Monsanto Expansion within State

Minn. House Panel Advances Plan for $16 Million to Mayo-UM Genomics Partnership

hESC Funding Restrictions Draw Fire from BIO President, Ex- Official from Georgia City

NC Biotechnology Center Conference on Combination Products

Gov. Heineman to Present Inaugural Bioscience Award at Bio Nebraska Annual Meeting

New Google VC Fund Targets Biotech, Healthcare, Tech Startups

Thrive's $9K in Grants Enable Five Madison, Wis.-Area Biotechs to Attend BIO 2009

Fall River, MA Gets Support for SouthCoast BioPark

Campanelli Co. Breaks Ground on New IDEX Health & Science Building

Biotage Cuts to Total Around 65 as Firm Preps US Move

San Diego Facility Designed by Kornberg Associates | Architects Serves as Gleaming Addition to Local Biotech Community

Nutra Pharma Branches Out into Contract Services

Catalent Changes

 

REST OF WORLD

UK's New £13.5M Genome Analysis Centre Eyes June Opening at Norwich Research Park

Shasun Chemicals Shuts Pharmaceutical Manufacturing Plant in Scotland

Aoxing Plant in China Gets GMP OK

GVK — Excel Alliance Reaches from India to China

LGC Opens Office in China to Raise Local Lab Standards

French Drug Maker Sanofi to Buy Brazil's Medley

China Looks to Expand Stake in Stem Cell Technology

New Training Facility at University in Holbeach, UK to Drive Food Sector Innovation

Piramal Moves UK API Operations to India

ReSearch Pharmaceutical Services Expanded Asian Market Via the Purchase of Chinese Contract Research Organization (CRO) Paramax International

Chinese CRO Has Stake in Good Laboratory Practice (GLP) Certified Laboratory at the Second Military Medical University (SMMU) in Shanghai

Preclinical CRO Porsolt Expands in France, U.S.

Nutra Pharma Branches Out into Contract Services

Final Curtain for India’s Shasun in Scotland

Catalent Sells French Solid Dose Plant to Bavaria’s Industriekapital

Catalent and Siga Develop Process for Anti-Smallpox Drug

Takeda to Move R&D Base to Illinois

 

 

 

 

Boston U's National Emerging Infectious Disease Lab Delays Opening

Delays in Safety Study pushed back the opening of BU's National Emerging Infectious Disease Lab.

A study looking into the safety of Boston University's newly built National Emerging Infectious Disease Laboratory has been delayed, which has in turn pushed back, to at least the coming fall, a court decision on the fate of the facility.

 

A court decision on the opening of the 192,000-square-foot, $198 million Biosafety Level 4 lab, entrenched in a long-running legal dispute, will be delayed until fall of 2010 at the earliest, and possibly later.

 

The study, which will be released for public comment, calls for the National Institutes of Health to perform supplemental risk analyses into the ability of the lab to contain 13 toxins to be studied there, and to ensure that it can be operated safely.

 

NEIDL is intended to perform basic and clinical research into infectious diseases, which in recent years have included West Nile virus, Ebola, avian flu, and HIV.

 

The supplemental risk analyses began last year but will take longer than the June 2009 timeframe projected late last year for completing a draft analysis report, NIH, BU, and Boston Medical Center Corp. stated in a legal filing submitted earlier this month to US District Court Judge Patti Saris.

 

"The NIH estimates that a draft of the supplemental risk analyses will be available for public comment during the winter of 2009-2010, followed by a final supplemental risk-analyses document that responds to all public comments made on the draft during the spring or summer of 2010, "the legal filing stated.

 

The corporation runs Boston Medical Center, a private, not-for-profit, 626-bed academic medical center that serves as the primary teaching affiliate for Boston University School of Medicine.

 

The supplemental draft risk assessment, conducted by Tetra Tech, is overseen by a panel convened in March 2008 by the NIH's Advisory Committee to the Director — four months after the National Research Council concluded that the NIH used flawed research methods in a draft supplemental environmental review.

 

That analysis concluded the NEIDL was safe, and did not make clear the reasoning behind those methods, or the findings derived from them.

 

The 16-member panel, which will next meet May 5 at NIH's Bethesda, Md., headquarters, is chaired by Adel Mahmoud, professor in the Department of Molecular Biology and Woodrow Wilson School of Princeton University.

 

According to the Jan. 9 edition of the NIH Record, the panel "will oversee the [supplemental risk assessment] study and report [its] results in June 2009."

 

The outcome of the panel process "will be a rigorous and comprehensive evaluation that will consider the questions and concerns raised by the public, the National Research Council, and the Federal and State courts with respect to construction of the NEIDL," the panel said in a Q&A posted on its web site.

 

"Upon review of the panel’s comments and suggestions, the NIH may do any or all of the following: conduct additional risk assessments, as warranted; revise the current draft supplementary risk assessments report, as necessary; solicit public comment on any new reports that may be generated; and submit final reports to the relevant authorities," the panel said.

 

Pfizer Expands Presence in Michigan

It has been more than 120 years since physician and pill pioneer W.E. Upjohn founded a company in his native city that would become one of the nation's largest drug makers.

 

Although The Upjohn Co. no longer exists, the pharmaceuticals industry remains a major employer in the Kalamazoo area, where Pfizer Inc. has about 3,200 employees.

 

Pfizer, the world's largest drug company, plans to dedicate a newly renovated, 780,000-square-foot laboratory and office facility in downtown Kalamazoo that Upjohn built in the early 1990s.

 

The $75 million project will house 680 employees and serve as the global headquarters of Pfizer's veterinary medicine research and development and animal genetics operations. Besides accommodating recent moves to the area by Pfizer veterinary medicine researchers from England and Louisiana, it also consolidates most laboratory and all office functions from operations in Kalamazoo and nearby Richland Township.

 

About $58 million went toward to cost of renovating existing work spaces and expanding into previously unused areas of the building. The remaining $17 million was spent on some of the latest research and testing equipment available to drug companies, including a state-of-the-art mass spectrometer to help identify proteins in genetics research.

 

"We're very, very fortunate to have the Upjohn legacy continue to prop our economy, undergird our economy here in Kalamazoo," says City Manager Kenneth P. Collard.

 

While Michigan recorded an unemployment rate of 12 percent in February, the city of Kalamazoo had a 12.2 percent jobless rate that month, the most recent for which county-by-county figures are available. But it has had some success attracting high-tech and life-sciences companies after losing hundreds of Pfizer jobs over the years.

 

Other Michigan cities have been less fortunate with Pfizer's restructuring decisions following the company's acquisition of Pharmacia Corp. six years ago.

New York City-based Pfizer announced in 2007 that it was shutting down its human health research and development facility in Ann Arbor, where it had 2,100 workers and was the city's largest private employer.

 

At the same time, the company announced that it was cutting 250 jobs in downtown Kalamazoo and 60 more in western Wayne County's Plymouth Township.

 

Many of the affected workers were offered jobs elsewhere at Pfizer, outside of Michigan.

 

In March 2005, Pfizer said it was closing a manufacturing plant with 328 employees in Ottawa County's Holland Township.

 

Pfizer had 9,000 employees in Michigan immediately after its April 2003 acquisition of Pharmacia, which had merged with Upjohn in 1995. Its work force in Kalamazoo County -- including the cities of Kalamazoo and Portage, and Richland Township -- has been halved, from 6,400 to 3,200.

 

"Really, Pfizer's presence in Michigan has become much more focused," company spokesman Rick Chambers says. "The manufacturing site in Portage and Kalamazoo is Pfizer's largest manufacturing operation in the world."

 

Its huge Portage facility makes medications for humans and animals and active pharmaceutical ingredients. The smaller Kalamazoo plant makes alcohol-based medicines.

 

Pfizer also operates a 2,100-acre research farm in Richland Township.

 

The Pfizer presence in the area extends beyond its own doors.

 

A number of former Pfizer and Pharmacia employees are involved in the more than two dozen life-sciences businesses that have been hatched at the Southwest Michigan Innovation Center since it opened in July 2003. The center is a business incubator at the Western Michigan University Business Technology Research Park in Kalamazoo.

 

In May 2007, Pfizer and Michigan State University announced that the company was giving the school a now-shuttered laboratory next to Pfizer's closed production plant in Holland Township, just north of Holland.

 

The university is to use the 138,000-square-foot, $50 million lab as an applied bio-economy research center for studying economic sectors that use biological resources. It will employ about 100 people when fully operational.

 

Meanwhile, the University of Michigan announced in December that it plans to buy Pfizer's former campus in Ann Arbor for $108 million. The school says its investment will create at least 2,000 research and other jobs over the next decade.

 

The 174-acre campus has almost 2 million square feet of laboratory and office space that the university says will allow it to expand its research in health, biomedical sciences and other fields.

 

Steve Forrest, vice president for research at the university, says he expects the school to close on the property in June.

 

As for Pfizer's decision to hold onto and renovate its Kalamazoo building, company officials express confidence that they have done the right thing.

 

"We're very proud of the scope of investment that we've made," says Dr. Katherine Knupp, vice president, veterinary medicine research and development.

 

Washington University Invests $235 Million to Construct Translational BioMedical Institute

An 11-story, 700,000 square-foot research tower is rising on the campus of Washington University in St. Louis, Missouri. The project, known as the BJC Institute of Health, is sourced out of the University's BioMed 21 program and has been in various stages of planning and construction dating back to 2003.  Expected to be complete by December of this year, the $235 million institute will serve to fulfill the BioMed initiative to speed up the entire "bench to bedside" process of scientific discovery.

 

OHSU to Start NIAID Center

The Oregon Health and Science University will use funding from the National Institutes of Allergy and Infectious Diseases to form a regional research center that will conduct a variety of studies on infectious diseases, including genomics research.

 

OHSU will use part of $40.7 million in NIAID funding to start the collaborative Pacific Northwest Regional Center for Excellence (RCE) for Biodefense and Emerging Infectious Diseases, which includes a new center at OHSU. The funding will be employed in collaborations with the University of Washington, which has already established an RCE in Seattle.

 

PNWRCE researchers will study a wide range of diseases classified as NIAID categories A, B, and C, including diseases and viruses such as ebola, dengue fever, SARS, avian and 1918 influenza, yellow fever, and West Nile.

 

The focus of the research will be on two areas, including genomics and genetics analysis studies of disease-host interactions and defects in the immune system caused by aging.

 

"Our program at the University of Washington in genomic technologies will dovetail nicely with the research proposed in the PNWRCE," said UW's Michael Katze, a professor of microbiology and the center's co-director.

 

The PNWRCE will work with public health departments in other Northwestern states to conduct training and research. These researchers also will collaborate with newly-funded science initiatives in the state such as the Oregon Translational Research and Drug Development Institute.

 

The Biodefense and Emerging Infectious Disease centers program at NIAID began in 2003 and currently operates ten centers around the country.

 

Philly's University City Science Center Debuts $1.2M POC Fund for Academic Life-Sci Projects

The Philadelphia University City Science Center and area academic partners officially launched the first round of a pilot program to provide funding for proof-of-concept studies performed by researchers at regional academic institutions who seek to commercialize their life-science discoveries.

 

As part of the first round of funding, a grant committee overseen by UCSC and comprising members of the local life sciences community will choose three applications submitted by 10 institutions from the greater Philadelphia area, Delaware, and New Jersey to receive one-year grants worth up to $200,000 each.

 

Competition for the grants could be stiff, however, as the pilot program, called QED, could receive as many as 300 applications according to pre-solicitations submitted to the UCSC, its president and CEO, Stephen Tang, told BTW last week.

 

Under the first phase of the QED program, which is thus far financed with $1 million from UCSC and another $200,000 from regional economic-development engine Ben Franklin Technology Partners, researchers from participating academic and research institutions are to submit project proposals including the amount of money needed to achieve proof of concept.

 

Academic institutions eligible to submit proposals for the first round are: Children's Hospital of Philadelphia, Drexel University, the Lankenau Institute of Medical Research, Rutgers University, Temple University, Thomas Jefferson University, the University of Delaware, the University of Pennsylvania, the University of the Sciences in Philadelphia, and the Wistar Institute.

 

UCSC said that it anticipates funding three projects from this group. The university or research institute associated with a winning project would be required to provide 50 percent of the project budget through a combination of in-kind and cash contribution, Tang said.

 

Projects are required to fall under the life sciences umbrella but can be in any category, from research tools to therapeutics to medical devices. Researchers interested in applying should do so in conjunction with their institution's tech-transfer office, but can find more information on the UCSC website. Though it hasn't provided a deadline for applications, the organization said that funding for round one would be available in September.

 

Though UCSC has formed an advisory committee for its operations, it has not yet created a team to review grant applications.

 

"We're looking for what sort of breadth in the research projects we'll need to accommodate," Tang told BTW. "If there is a large focus on therapeutics … then we'll need to recruit people that can evaluate therapeutics.

 

"We have done a pre-solicitation so we know where the general areas of interest are," he said, declining to elaborate. "But we're not sure if that will map directly into the types of proposals we're going to receive."

 

Nevertheless, one of the main criteria for funding will be whether a project is "investment-grade," Tang said, adding that a fundable project will be one in which there is likely further investment interest.

 

"The researcher will make a proposal as to how much money is needed, and we will look at whether it is really possible to prove concept in the amount of time for the money requested," he said. "Doing what you say you will do is important."

 

Thus, although projects are eligible to receive as much as $200,000, the actual grant could be less depending on the need of the project.

 

George Pipia, associate director of business development at the Wistar Institute, said that the funding program may help support applied research projects that typically have a difficult time attracting federal funding.

 

With this challenge in mind, the QED funding program "gives us an additional venue to potentially increase the value of the invention," Pipia said. "It's extra money that you can apply to the most promising, most advanced projects."

 

Two Wistar scientists have already applied for funding, Pipia said. One is Paul Lieberman, a professor in Wistar's gene expression and regulation program, who is developing inhibitors of Epstein-Barr virus and has been trying to conduct high-throughput screens of compounds against specific viral gene targets.

 

"QED would be a perfect fit for this project so that hopefully he can do this experiment," Pipia said. "Once he finds small molecules that work in his screening assay, it would be much easier to find outside funding."

 

A second Wistar researcher, Qihong Huang, an assistant professor in the molecular and cellular oncogensis program, seeks to develop a high-throughput screen of molecules that can suppress oncogenic microRNAs.

 

"Again, it's very difficult to get a grant from the [National Institutes of Health] for this type of very applied research," Pipia said.

 

As reported in February by BTW sister publication BioRegion News, UCSC unveiled the QED program at the time to provide a boost to bio-related tech transfer and economic development in the region.

 

QED — an abbreviation of the Latin phrase quod erat demonstrandum, literally translated as "which was to be demonstrated" — was to be rolled out in three phases, with different groups of regional institutions eligible to receive awards in each phase.

 

According to BioRegion News, Tang said during the February press event that the center would collect project pre-solicitations through the end of March, and planned to issue its first request for proposals in June or July.

 

However, intense interest accelerated the QED grant process, and Tang and other UCSC officials worked with the first group of area institutions to negotiate funding terms and conditions.

 

As a result, UCSC sent out its first request for white paper proposals last week. Tang said that pre-solicitations revealed that the program may receive as many as 300 grant applications.

 

"What's driving that interest is the current climate, and the fact that many projects aren't getting funded at all," Tang said. "We expect the number of applications to be high and the quality to be high."

 

Though QED has enough funding to last for the three-round pilot program, Tang said that he hopes to make the program evergreen by receiving a cut of any profits that might be generated by projects receiving funding.

 

"Sustainability of the program is one of our key goals," Tang said. "If projects we fund go on to become bona fide companies or develop into commercial products, there are certain provisions" that would direct undisclosed royalties and/or equity returns to the QED program, he added.

 

"The milestone we came to [last week] was coming up with agreement that worked for all institutions," Tang said. "It would be an equity position and a royalty position. We tried to present numbers that would be palatable to each organization."

 

Tang said that there were multiple challenges associated with this goal.

 

"This is one of the first, if not the first, attempts to create a multi-institutional proof-of-concept program in the country," Tang said. "You have different maturity levels in understanding tech transfer at the university level. There are very prominent universities involved with experienced tech-transfer people. And there are some institutions that are newer to tech transfer and more inexperienced."

 

In September, around the same time the first awards are being made, QED will release another request for proposals for technologies developed at Fox Chase Cancer Center, Monell Chemical Senses Center, Philadelphia University, Rowan University, Villanova University, and Widener University.

 

And early next year, a third RFP will go to researchers from Delaware State University, East Stroudsburg University, Lafayette College, Lehigh University, Lincoln University, the Philadelphia College of Medicine, Salus University, and Swarthmore College.

 

Tang said QED will likely fund five projects from the second group and as many as 10 projects from the third group.

 

Another notable part of the QED initiative is its plan to recruit regional entrepreneurs and life-sciences executives to pair with grant winners. This is designed to serve two purposes: to provide entrepreneurial guidance to university researchers who "probably have little experience in the commercial world," and to give local life-sciences leaders a window into potential investment opportunities.

 

"We're designed to get the ball rolling," Tang said. "There will be skin in the game from other entities in the region — that's why we have them involved."

 

Pfizer Opens St Louis R&D Centre

Pfizer’s new $200m (€152m) research centre is up and running, bringing to an end the firm’s four year project to amalgamate its existing research facilities in St Louis, Missouri, US.

 

According to Pfizer’s website the facility will focus on the development of drugs for arthritis, osteoarthritis and inflammatory pain, making it part of the small molecule R&D division the firm will form when it completes the acquisition of Wyeth.

 

Don Frail, director of the Chesterfield site, told St Louis’ KWMU radio station that 250 researchers will move into the facility over the next two months as necessary validation work is completed.

 

He went on to say that eventually the facility will house around 1,200 Pfizer employees and that this central location will provide a collaborative environment stimulating innovation.

 

ReSearch Buys Chinese CRO

ReSearch Pharmaceutical Services has expanded its activities into the Asian market via the purchase of Chinese contract research organization (CRO) Paramax International.

 

Delaware, US-based RPS will pay around $1m in cash as well as around 531,000 shares to gain control of Paramax, with the transaction due to complete sometime next month.

 

The move will give RPS expanded capabilities in the Asian market, said RPS, which has already expanded from the US into Europe and Latin America in the last couple of years.

 

RPS first started a push to internationalize its business in 2006/2007 with an expansion into Latin America, and followed it up in 2008 with a push into Europe. Last December, RPS bought France’s Therapherm Recherches, Imerem of Germany and Spanish CRO Infociencia for a total of €7.4m, plus stock. The company says 2009 will mark its expansion into Asian markets.

 

“The acquisition of Paramax will be a key event in the expansion of our existing operations for providing globally integrated clinical research services,” commented RPS’ chief executive Dan Perlman.

 

Paramax, set up in 2003, represents the first phase of that expansion. The company has headquarters in Beijing and an operations office in Shanghai which will serve as RPS’ Asian headquarters.

 

Chinese CRO Has Stake in a Good Laboratory Practice (GLP) Certified Laboratory with China’s Center for Evaluation of Drug Safety at the Second Military Medical University (SMMU) in Shanghai.

It specializes in toxicology and pharmacology studies, clinical monitoring, patient recruitment and clinical data management and biostatistics. Paramax also offers consulting, regulatory affairs, project management and medical writing services.

 

RPS’ 2008 results, published last week, indicate that its service revenues advanced more than 30 per cent to $157m, with earnings before interest, taxes, depreciation and amortization up a third to $8m.

 

U of Cincinnati Lands $22.7M from NCRR

The University of Cincinnati will use $22.7 million from the National Institutes of Health to start a translational research center that will partner with hospitals in the region to delve into a variety of biomedical science areas including studies that involve proteomics, gene transfer, bioinformatics, imaging, and other applications.

 

The National Center for Research Resources grant will be spread over five years, and will fund a Center for Clinical and Translational Science and Training (CCTST), which will be a partner in the 39-member NIH-funded Clinical Translational Science Award Consortium.

 

The center will support the Cincinnati Children's Hospital Medical Center and will collaborate with the Cincinnati Veterans Affairs Medical Center. It also will focus on coordinating and planning the overall direction of the university's research infrastructure and training opportunities, serving needs of researchers, and fostering career development.

 

"As part of this national clinical and translational research network, the University of Cincinnati will focus on both pediatric and adult diseases and will increase the breadth of consortium activity throughout the Midwest, bringing research advances into the communities it serves," NCRR Director Barbara Alving said in a statement.

 

The CTSA consortium began in 2006 and when it is fully implemented in 2012 it will connect approximately 60 centers and have an annual budget of around $500 million.

 

NCRR said in a release that it plans to award more consortium grants this year and will continue taking application for grants it will award in 2010. More information on the CTSA is available at NCRR's website.

 

New England Cummings School Dedicates Regional Biosafety Laboratory

The Cummings School of Veterinary Medicine dedicated the New England Regional Biosafety Laboratory to the development of new diagnostic tools, therapies, and vaccines for infectious diseases at a ceremony at the laboratory site. The event commemorated the completion of construction of the $31-million laboratory, which will examine infectious diseases as part of a network of 13 regional biosafety laboratories nationwide commissioned by the National Institutes of Health.

 

The New England Regional Biosafety Laboratory will also serve as a regional resource for researchers who require access to Biosafety Level 2 and 3 and Select Agent facilities. It is also the anchor tenant of the Cummings School's Grafton Science Park, a 100-acre build-to-suit area fully entitled for up to 702,000 square feet of commercial life science, medical device, and medical-related space.

 

Earmark to Help Utah’s Idaho Technology in Identifying Health Hazards

A Salt Lake City-based biotechnology company has completed construction on a new $8.5 million, 41,000 square-foot facility charged with developing applications to detect biological warfare and other potentially harmful infectious health hazards, thanks in part to a government earmark.

 

Speaking at ribbon-cutting ceremony at the University of Utah Research Park for the Idaho Technology Inc.'s new manufacturing and administration building, U.S. Sen. Bob Bennett, R-Utah, told an audience of more than 100 people that if used properly, earmarks could help aid communities in various ways.

"The government was going to spend the money on research anyway," he said. "By spending it here they are going to get the return in terms of tax revenue both from the profits of the company and the income taxes of the employees."

 

Earmark funding is money in a budget for a specific project. Earmarks are sometimes criticized on the federal level because members of Congress use them to fund projects in their districts, often without any public debate.

 

Bennett said that while there have been abuses in the system where earmarks have been used to fund projects such as the infamous "Bridge to Nowhere" in Alaska, the funds are most often used to support worthy projects such as the new Idaho Technology facility.

 

Idaho Technology Inc., a private company with about 220 employees, makes devices that identify potentially harmful chemicals used in bio-warfare and contamination of the food supply. In addition, the company uses similar technology to amplify DNA and detect the cause of certain diseases, CEO Kirk Ririe, told the Deseret News in an interview.

 

"We build test kits that detect bugs that can kill you," Ririe said. "Viruses, bacteria, anything that is potentially harmful to people."

 

He said that included infectious germs such as anthrax, the plague, salmonella and e-coli.

 

Ririe said the company's products are used by the military, food companies and healthcare providers. He said that the company is currently developing a technology that would readily identify and diagnose harmful ailments.

 

"We are working on something that is incredibly cool," he said. "A way of diagnosing complex illnesses, and doing it quickly." Ririe said that, if successful, the new technology would allow a person to "come into your doctor or hospital sick, find out what is making you sick and get the appropriate treatment."

The initial focus would be on infectious illnesses such as respiratory distress, blood poisoning or sepsis, he said.  "Where there's a defined symptom, but an unknown cause and you go after the cause," Ririe said.

 

The technology should enter the clinical trial stage later this year and, if approved by the U.S. Food and Drug Administration, the product could be on the market sometime next year, Ririe said.

 

Shire to Shut Owings Mills, Md., Plant, Idling 260; Shifting Work to CRO in NC

Shire confirmed it will shut its Owings Mills plant in phases over three years, laying off the plant's 260 workers, and shift the manufacturing of drugs produced there to a contract research manufacturer in North Carolina.

 

Shire told employees April 1 that it would begin the 36-month process of shutting the Owings Mills plant, in which the company will phase out manufacturing one drug at a time. Those products include: Adderall XR and Vyvanse, which are both used to treat ADHD; Carbatrol, which is used to treat epilepsy; and Pentasa, which is used to treat ulcerative colitis and Crohn's disease.

 

"Our strategy at Shire, in short, does not include in-house manufacturing," Shire spokesman Matt Cabrey told the Baltimore Sun. Cabrey said the decision "is in no way related to the economic downturn in the US or the global economy. It is strictly related to the strategy that Shire has in place for growth."

 

Shire purchased the 100,000-square-foot plant and warehouse, on Gundry Lane, in 2002 from Atlantic Pharmaceutical Services, a contract manufacturer that had been making some of Shire's products. Shire invested about $65 million in buying the facility, purchasing additional land, and building a new pharmaceutical technology center, which opened in 2006, to do small-batch testing.

 

The company will continue to produce enzyme replacement therapies for rare genetic diseases from a manufacturing site in Massachusetts.

 

Cabrey told the Sun that Shire tried to sell the Owings Mills facility but could not find a buyer. He said the company plans to market the space to pharmaceutical companies, and will work with the Baltimore County Department of Economic Development to find prospects.

 

"It will be a priority of the department to try to retain this facility as an operating pharmaceutical" plant, David Iannucci, executive director of economic development, told the newspaper.

 

Takeda Moves Global Development HQ from Osaka, Japan to Deerfield, IL

Takeda Pharmaceutical announced it would move its global development headquarters to Deerfield, Ill., a move it anticipated completing by July 1. Until now, Takeda, Japan's largest drug manufacturer, has based its development effort in Osaka, Japan, and maintained regional hubs in Japan, the US, Europe, and a recently established Asian subsidiary.

 

Takeda said the shift was part of its mid-term plan of stepping up activity and introducing new products ahead of the 2011 patent expiration of its hit diabetes drug Actos. The Japanese drug maker stands to lose substantial revenue after Actos expires and has been working to develop new drugs to fill the expected revenue gap.

 

Earlier this month, the company hit a roadblock when the Food and Drug Administration said that the existing clinical data for its new diabetes drug SYR-322, known as alogliptin, was not sufficient. The FDA says it will rule on the drug by June 26.

 

Wareham Breaking Ground on Three East Bay Projects Totaling 380,000 Sq. Ft.

Wareham Development will launch at least one new big office and research complex in the San Francisco Bay area's East Bay region this year — even if the project has to be built on a speculative basis, without a signed tenant, the Oakland Tribune reported.

 

Wareham, which is based in San Rafael, CA, is planning to build:

"We have to grow our laboratory space in the market by a quarter-million square feet every two to three years," Richard Robbins, Wareham's principal executive and founder, told the Tribune. "Otherwise we will lose our ability to keep our part of the life sciences sector strong."

 

Wareham succeeded with a spec project two years ago, when it developed the 245,000-square-foot EmeryStation East building in Emeryville. Amyris Biotechnologies and Novartis later signed leases for space there. Weeks later, the Joint BioEnergy Institute, or JBEI, agreed to move its headquarters to the project. The developer also accommodated significant expansions by Bionovo and Origin Therapeutics. EmeryStation East is 90 percent leased, Robbins told the newspaper.

 

Path Commits to Future 111,000 Sq. Ft. Lease at Seattle's 2201 Westlake Project

Health research organization Path said that it had signed a letter expressing its intent to relocate and expand its current 75,000-square-foot, 300-person headquarters in the Ballard section of Seattle to three floors totaling 111,000 square feet in Microsoft co-founder Paul Allen's new 2201 Westlake development, in the South Lake Union section of downtown Seattle.

 

Earlier this year Microsoft signed a letter of intent to take the entire roughly 300,000-square-foot, 12-story office building, but did not follow through on that commitment by signing a lease.

 

Path said it is tentatively planning to move into 2201 Westlake in January 2010.

 

Founded as the Program for the Introduction and Adaptation of Contraceptive Technology in 1977, Path began searching for space for a year after doubling its staff over the past decade, maxing out its available space. In addition, according to GlobeSt.com, the HRO wanted to locate to an energy-efficient "green" building; 2201 Westlake has been designed to qualify for the second-highest "Gold" certification of the US Green Building Council's Leadership in Energy and Environmental Design rating system.

 

Path said in a statement that the tentative agreement with Allen's development entity Vulcan provides "affordability in the short and long term, flexible space that can accommodate … growth, [and an] environmentally friendly building with easy access to green transportation options."

 

Path also noted that the location will put it closer to partners in the Washington Global Health Alliance and the region's leaders in research, health, and technology — including Seattle Biomedical Research Institute, Seattle Children's Research Institute, the University of Washington's biotechnology and medical research hub, the Fred Hutchinson Cancer Research Center, and the Bill & Melinda Gates Foundation.

 

The office building at 2201 Westlake is part of a 450,000-square-foot mixed-use project over half a city block, set to open in May on Seattle's new streetcar line. The project includes a 19-story office and residential tower with 135 condominiums; 25,000 square feet of street-level retail space, and a six-level underground parking garage.

 

Sellen Construction is the contractor for 2201 Westlake, and Callison the architect. CB Richard Ellis' Roy Mann and Tom Pehl represented PATH as advisors/consultants, while CBRE's Ray Attisha served as an advisor to Allen's Vulcan.

 

Fall River, MA Executive Park Wins $17 Million in State Grants; First Tenant Will Be UMass Bioprocessing Facility

Massachusetts will award a total $17 million in state grants toward the development of Fall River Executive Park, whose first anchor tenant will be a University of Massachusetts/Dartmouth bio-processing facility.

 

The funding consists of a $15 million grant through the Massachusetts Opportunity Relocation and Expansion job program for design and construction of the bio-processing pilot facility, as well as a $2 million grant from the state Growth Districts program being awarded to Fall River to expand Riggenbach Road and build an access road to the executive park.

 

The facility will be designed assist life sciences companies in testing their biomanufacturing processes at production scale, training current and future workers, and locating outside of the Boston/Cambridge region. The core facility will include construction of two large-scale suites, a purification suite, a quality control lab, an education classroom and teaching laboratory, a small research incubator laboratory, and basic office capabilities. The idea was initially developed with seed funding provided by President Jack Wilson from the UMass Science and Technology Fund.

 

The executive park, also called the SouthCoast BioPark, will rise on 300 acres off the planned Route 24 interchange, a $60 million project that will include a ramp between exits 8 and 9.

 

"This exciting project builds on our investment in the life sciences supercluster and creates long-term regional prosperity in an environmentally responsible manner," said Greg Bialecki, Massachusetts' secretary of housing and economic development, in a statement.

 

To develop the project, the city of Fall River will receive 300 acres of state land for the executive park for $2.45 million. In return, the commonwealth will receive conservation restrictions on 4,200 acres of city-owned property within the 14,000-acre Southeastern Massachusetts Bioreserve, intended to permanently preserve a habitat deemed by the state as environmentally sensitive. Created in 2001, the bioreserve is managed by the city, the nonprofit group Trustees of Reservations, the Massachusetts Department of Conservation and Recreation, and the state Department of Fish and Game's Division of Fisheries and Wildlife.

 

Mexico's Silicon Border Sci-Tech Park Completes First Phase of Infrastructure Development.

Silicon Border, the $150 million, 10,000-acre science and technology park planned for Mexicali, within Mexico's Baja California region, has completed infrastructure designed to support the 500-acre first phase of its manufacturing development, targeted for alternative-energy "green" technology companies.

 

As a result, phase one "is ready for current and future tenants to begin construction of their manufacturing facilities," developer Silicon Border Development and contractor Grupo Maiz said in a statement.

 

The infrastructure, financed by ING Clarion, consisted of potable water plant and distribution, fiber optic telephone and data cable, power substations, and waste treatment facilities. The water treatment plant has been designed to recycle up to 90 percent of the water used within the park. The remainder will be set aside for irrigation and other uses within the park.

 

By 2011, the developers anticipate completing construction of additional infrastructure to support the 900-acre phase two of Silicon Borders. Work will include installation of redundant sources of power and water for all park tenants.

 

Silicon Border said its project is the world's first science park to make exclusive use of LED lighting for all of its roadways and parking lots. Silicon Border conforms to the Leadership in Energy and Environmental Design energy-efficiency standards developed by the US Green Building Council.

 

Component Maker Sapphire Engineering Eyes Move to $9M Middleboro, Mass., Plant

Sapphire Engineering, a manufacturer of precision components used by biotechnology companies as well as telecom and semiconductor businesses, will move by year's end into a $9 million, 80,000-square-foot office and manufacturing building now under construction within Campanelli Business Park in Middleboro, Mass.

Contractors hired by business park owner Campanelli Cos. of Braintree, Mass. began construction after Sapphire's parent company Idex of Northbrook, Ill., signed a 10-year lease for the build-to-suit building. Idex was represented in lease talks by CB Richard Ellis partners Steven Clancy and Christopher Tosti.

 

Sapphire will consolidate its Bourne and Hopedale operations at the Middleboro facility, which is set to be completed in December and employ 170 people. About two-thirds of the building will be used for manufacturing, with office space occupying most of the remainder.

 

Campanelli announced in a statement that it broke ground on the building in March after receiving final permits the previous month. Middleboro officials last year granted a tax-increment-financing agreement as an incentive for Sapphire to select the town over neighboring Taunton, Mass. Sapphire will pay $1.3 million in property taxes over the course of the 20-year tax agreement.

 

"This is a very good company that's very solid and the type of business we want in town," Anna Nalevanko, Middleboro's director of economic and community development, told the Patriot Ledger of Quincy, Mass.

 

Idex solicited proposals from several industrial park owners in Southeastern Massachusetts before signing with Campanelli, the newspaper reported. Sapphire will be the 12th business and ninth building in the 220-acre Campanelli Business Park, and has rights to expand within the business park by an additional 25 percent.

 

UC Davis' MIND Institute Maps Out $40M Expansion of Sacramento Complex

The University of California, Davis' Medical Investigation of Neurodevelopmental Disorders, or MIND, Institute has made preliminary plans to add a three-story, 30,000-square-foot building on its 11-acre site, within the UC Davis Medical Center's Sacramento campus, according to the Sacramento Business Journal.

 

MIND now occupies a 100,000-square-foot complex that opened in July 2003 and is at capacity. The institute has grown with recognition of the neurodevelopmental disorders it studies – especially the spectrum of child development disorders that comprises autism.

 

The cost of the expansion is almost $40 million. MIND supporters have raised $500,000 toward the $27 million they need for construction costs and an endowment fund to cover operations, the newspaper reported.

 

Doe & Ingalls of North Carolina Celebrates Grand Opening of Riverside, CA Facility

Durham-based Doe & Ingalls of North Carolina, an East Coast provider of chemical services, has opened its newest chemical services center in Riverside, Calif., with the goal of supplying West Coast customers, in part by offering next-day delivery in California. The company began shipping orders from the new location on April 1.

 

Customized to serve biotech and microelectronic customers, the 43,000-square-foot facility has more than 1,500 pallet locations and 39,000 square feet of H3/H4 hazmat storage.

 

Doe & Ingalls said its Riverside chemical services center was designed to meet regulations for secure handling and storage of hazardous materials; meet the standards for raw material control and compliance that apply to biotechnology and microelectronics customers and suppliers, and deliver a variety of supply chain services ranging from distribution and logistics, to custom inventory management programs, and on-site sampling.

 

The facility employs GMP storage and handling guidelines, and features redundant power systems, coated flooring, temperature-control and humidity monitoring. The facility has space for chemical management and logistics, as well as reserved areas for future onsite sampling and cold storage, based on customer demand.

 

Covaris Extends Lease, Expands to 14K+ Sq. Ft. at Woburn, MA Life-Sci Cluster

Life science instrument company Covaris has extended its lease with Cummings Properties for space at 14 Gill St., within its Gill Street Life Sciences Cluster, and expanded its space there by 50 percent to more than 14,000 square feet.

 

Privately held Covaris, established in 1999, makes instrumentation for biological and chemical applications used by pharmaceutical and biotechnology companies worldwide.

 

Tony Spencer, Cummings Properties' leasing/property manager, represented Covaris in the lease expansion and extension; the instrument company was represented by in-house professionals. In a statement, he said Covaris looked elsewhere, but stayed where it was because of its below-market lease rates, a guarantee of expansion space, and proximity to amenities and other life science firms.

 

"Woburn continues to be an invaluable location for our company as it is both near our key suppliers and is readily accessible to one of our major customer market segments, namely the pharmaceutical and biotechnology community of the greater metropolitan Boston area," Covaris President James Laugharn said in a statement.

 

Located 11 miles northeast of Boston, Gill Street Life Sciences Cluster is home to more than two dozen established and start-up life-sci firms.

 

With $250K from Maryland, Life Technologies Eyes Adding 50 Workers to Frederick R&D Center, Stem Cell Office

Life Technologies plans to add 50 workers to its workforce of 250 employees at the Frederick, Md., facility that houses its R&D center and stem cell marketing department, in return for a $250,000 grant from the state of Maryland. The grant is part of the $1.3 billion Maryland plans to spend on life sciences initiatives under Gov. Martin O'Malley's 10-year BIO 2020 program, which the state has projected will generate a total $6.3 billion in private and federal investments by 2020.

 

Maryland Department of Business and Economic Development Secretary Christian Johansson announced the state grant at the facility, 7305 Executive Way, where he and Life Technologies CEO Greg Lucier toured the $900,000, 6,600-square-foot space.

 

Uplaksh Kumar, Life Technologies' director of Frederick operations, told the News-Post of Frederick that the region's educated and experience workers were key to the company maintaining R&D, manufacturing, information technology, and distribution jobs in Maryland's second-largest city.

 

Headquartered in Carlsbad, Calif., Life Technologies was formed last November after Invitrogen and Applied Biosystems completed a merger. The company's biggest customer is the National Institutes of Health.

 

BioMed Realty's Center for Life Science | Boston Achieves LEED Gold Certification

BioMed Realty Trust's Center for Life Science | Boston has achieved Gold Leadership in Energy and Environmental design, or LEED, certification for the 700,000-square-foot lab building's core and shell from the US Green Building Council. The designation is based on the center's attaining standards for sustainable site development, water savings, energy efficiency, materials selection and indoor environmental quality.

 

Located in Boston's pricey Longwood Medical Area, the Center for Life Sciences is 91 percent leased to Beth Israel Deaconess Medical Center, Children's Hospital Boston, Dana Farber Cancer Institute, Immune Disease Institute, and Japanese-owned Kowa Company.

 

BioMed has previously attained LEED certification for:

• 500 Kendall Street in Cambridge, Mass. achieved the highest-available Platinum LEED certification. The building is entirely leased to Genzyme.

 

• The 84,000 square foot built-to-suit laboratory and office facility at 9865 Towne Centre Drive in San Diego, which was completed in July, 2008 and received Silver LEED certification. The property is entirely leased to Illumina.

 

• 650 East Kendall Street in Cambridge, a 280,000-square-foot joint development of BioMed and Prudential Real Estate Investors set to be completed later this year. The project has received LEED Gold pre-certification.

 

BioMed said it is also in the process of obtaining LEED certification for its 302,919-square-foot 675 West Kendall Street building in Cambridge, which is 100 percent leased to Vertex Pharmaceuticals. BioMed is seeking a Gold LEED certification.

 

Shasun Chemicals Shuts Pharmaceutical Manufacturing Plant in Scotland

Indian-owned Shasun Chemicals shut down its Shasun Pharma Solutions pharmaceutical manufacturing plant near Annan, Scotland, almost six months after saying that the facility was "underused" and could not be sustained, according to Outsourcing-Pharma.com

 

The plant's 86 employees lost their jobs following the shutdown of the plant in Newbie. The facility offered custom development and manufacturing services to pharmaceutical and biopharmaceutical customers, and was one of two facilities operated by Shasun in the UK. The other facility, in Dudley, Northumberland, continues to provide pilot- to commercial-scale production of APIs and intermediates.

 

Shasun conducted research in India, and built up its capacity for development and manufacturing — at kilo laboratory and pilot plant scale — that could be conducted either in the UK or India. The company's UK operation suffered a setback last year, when Shasun announced plans to invest in a process development facility in Piscataway, NJ, following operational problems at the Annan facility that impacted Shasun's 2007 financial results.

 

A team of 30 staff will stay on at Newbie until June to dismantle the facility. Shasun Pharma Solutions President Kevin Cook has said the company is speaking to a potential buyer interested in maintaining pharmaceutical manufacturing at the plant.

 

Maryland Senate OKs $6 Million for Biotech Tax Credit Program in FY'10 Budget Bill

Maryland's state Senate voted as expected to retain the full $6 million proposed by Gov. Martin O'Malley for the state's Biotechnology Investment Tax Credit program, as part of the $13.8 billion operating budget approved for the fiscal year starting July 1.

 

The funding fate of the biotech tax credits will rest with a conference committee of state senators and members of the House of Delegates, which voted to cut funding for the program to $4 million.

 

While the legislature or General Assembly was supposed to pass a budget by April 6, that had yet to occur at deadline, and the deadline can be pushed back. The legislative session is scheduled to end April 13. According to Maryland Community Newspapers, pending bills include one requiring the Maryland Technology Development Corp., also known as TEDCO, to organize public-private partnerships to boost nanobiotechnology research in the state. That measure passed the House, and was under review in the Senate.

 

Missouri Tax Credit Advocates Say Bill Could Entice Monsanto Expansion within State

Supporters of a Missouri state Senate bill that would award biotechnology employers a tax credit equal to a percentage of their research expenses say the measure could help persuade Monsanto to select the Show Me state rather than Iowa as the site of a planned expansion.

 

The tax credit is part of Senate Bill 45, introduced by state Sen. David Pearce (R-Warrensburg). The measure is in the Senate's Jobs, Economic Development and Local Government Committee, where it faces opposition from some state senators opposed to what they deem excessive economic incentives for large businesses.

"We cannot continue to piece off all of the natural growth and say we will not tax it. Just because the neighbors are doing something stupid, does that mean you're going to do something stupid too?" state Sen. Matt Bartle (R-Lee's Summit), told the Associated Press.

 

Bartle is among a group of Republican state senators who have counter-proposed capping most tax credit programs, as well as allowing lawmakers to set total amounts of spending on each credit program while considering state budgets. State Senators narrowly rejected the latter stipulation 18-16, then agreed to re-insert the budget provision after state Sen. Jason Crowell (R-Cape Girardeau) began filibustering the bill.

 

State Sen. Tom Dempsey (R-St. Charles) acknowledged that tax credits have "cannibalized" state resources, but maintained to the wire service that incentives were the best way to attract companies: "We're playing that game. If you don't play in the game, you get left behind."

 

Pearce's bill would allow companies to receive a credit equal to 3 percent of research costs up to $2.5 million; 5 percent between $2.5 million and $5 million; and 7.5 percent for costs exceeding $5 million. Individual companies could not receive more than $2.1 million in credits each year. The tax credit is part of a larger bill that includes an expansion of Missouri's Quality Jobs Act sought by Gov. Jay Nixon, a Democrat who took office in January.

 

Monsanto "has long supported" the tax credit, spokeswoman Danielle Stuart told the AP, without stating it was a prerequisite to the expansion being considered by the company — which she said would over four years generate 1,500 jobs, most of them researcher, scientist, and office worker positions.

 

Dempsey has introduced another bill pending before the same committee. Senate Bill 572 would create a new Missouri Science and Innovation Reinvestment Authority that would "create, attract, and enhance new and existing science and innovation companies in the state and make Missouri the most attractive state for conducting, facilitating, performing, and supporting science and innovation research, development, and commercialization."

 

The authority would be similar to the Kansas Bioscience Authority, credited with attracting and retaining dozens of life-sci businesses to that state, as well as the National Bio- and Agro-Defense Facility, set to rise on the Manhattan, Kans., campus of Kansas State University [BRN, Dec. 8, 2008].

 

Minn. House Panel Advances Plan for $16 Million to Mayo-UM Genomics Partnership

A proposal by Minnesota Gov. Tim Pawlenty to guarantee $16 million in funding for the University of Minnesota and Mayo Clinic's genomics partnership in the state's next two-year budget appeared to be advancing through Minnesota's state legislature, when a House committee agreed to consider including the provision in a larger bill related to higher education and workforce development funding, the Post-Bulletin of Rochester, Minn., reported.

 

Rep. Kim Norton (DFL-Rochester) is sponsoring the bill, which would award the money to the university-Mayo entity Minnesota Partnership for Biotechnology and Medical Genomics. That is the same amount that Pawlenty, a Republican, recommended as part of his budget. A similar bill is being sponsored in the Senate by another Democratic-Farmer-Labor state senator from Rochester, Ann Lynch.

 

Norton's bill would also prevent the University of Minnesota's Board of Regents from unilaterally cutting funding from the partnership without first consulting lawmakers and partnership members. That provision comes a year after the state Board of Regents, in a budget-cutting move, sliced $3 million from the $25 million appropriated for the partnership by the Legislature.

 

hESC Funding Restrictions Draw Fire from BIO President, Ex- Official from Georgia City

The president of the Biotechnology Industry Organization and a former City council member from East Point, GA, have criticized the concept of restricting government funding of human embryonic stem cell research in part by citing impact on individual states.

 

In Arizona, which restricts public hESC funding, BIO President James Greenwood told an audience in Phoenix that Arizona's scientists and citizens are missing out on a potential lucrative source of research funds and medical benefits. Lifting such restrictions "seems to be a no-brainer," Greenwood said March 27, according to the Arizona Republic, which also quoted him as adding: "They are going to be destroyed one way or another."

 

Arizona's restrictions include a ban on conducting research on cells collected from an aborted fetus, as well as using federal, state, or private money on human cloning.

 

"My hope and expectation is the science will allow research beyond the use of embryonic stem cells, and it will get the same results," Bob Eaton, president and CEO of the Arizona Bioindustry Association, told the Republic.

 

In an opinion column published in the Atlanta Journal-Constitution, former East Point (Ga.) City Council member Teresa Nelson faulted Georgia Gov. Sonny Perdue for supporting proposed hESC funding restrictions

 

Nelson said the restrictions could negate efforts by Perdue to redevelop the US Army base Fort McPherson, set to close in 2011, by trying to draw a bioscience research facility as an anchor.

 

"Perdue may have destroyed the possibility that a future bio-science research center will be located anywhere in Georgia — let alone at Fort McPherson," Nelson declared, adding: "Why would a biotechnology firm choose to locate in a state where a threat to restrict the firm's research constantly loomed? They'll head to friendlier states. What will the economic engine be to redevelop Fort McPherson then?"

 

NC Biotechnology Center Conference on Combination Products

The state-funded North Carolina Biotechnology Center held a conference focused on new business opportunities arising from the creation of combination products — a result of the merging of drugs, devices, and biologics.

 

Scientists, engineers and entrepreneurs from throughout North Carolina attended the event, at the biotech center's headquarters in Research Triangle Park.

 

Speakers included John Barlow Weiner, associate director for policy in the US Food and Drug Administration's Office of Combination Products, and the agency's product-classification officer; Ken Tindall, senior vice president of science and business development at the biotech center; and Sam Taylor, president of the North Carolina Biosciences Organization.

 

Taylor provided an update on the biotech center-funded Center of Innovation in Advanced Medical Technologies, formed to create and support companies that develop combination products, among other technologies. The AMT center recently received a $2.5 million, four-year grant from the biotech center toward supporting commercialization of new products, as well as recruitment and expansion of companies developing advanced medical technologies.

 

Gov. Heineman to Present Inaugural Bioscience Award at Bio Nebraska Annual Meeting

Nebraska Gov. Dave Heineman will present the inaugural Governor's Bioscience Award during the Bio Nebraska Life Sciences Association's 2009 Annual Meeting, set for Thursday (April 9) at the Strategic Air and Space Museum in Ashland, Neb.

 

The event will begin with a membership meeting membership to include presentations by Lori Reilly, vice president for policy and research at the Pharmaceutical Research and Manufacturers of America or PhRMA; and Peter Pellerito, senior policy consultant in state government relations and university outreach for the Biotechnology Industry Organization and managing director of PMP Public Affairs Consulting, based at North Carolina's Research Triangle Park.

 

New Google VC Fund Targets Biotech, Healthcare, Tech Startups

Google said that its new venture capital fund — to be based jointly in Cambridge, Mass., and at its corporate headquarters city of Mountain View, Calif. — will seek to do deals with "exceptional" startups specializing in biotechnology as well as healthcare and consumer Internet, software, and alternative-energy "clean" technologies.

 

While Google has not confirmed the size of its fund, the Wall Street Journal and the

Boston Globe said the Internet giant would spend $100 million on its new Google Ventures.

 

"The goal is to follow the best practices of a top-tier venture capital firm, but to do that inside Google, where we can leverage Google's lens on what's interesting," Rich Miner, a Cambridge-based managing partner of Google Ventures, told the Globe.

 

Miner is one of two managing partners of Google ventures; the other, Bill Maris, has a background in biotechnology and healthcare, and will be based in Mountain View. Before joining Google, Maris managed the biotechnology and health care portfolios for Stockholm, Sweden-based Investor AB, and carried out scientific research into cholinergic visual pathways, cell membrane patch clamping techniques, and in vivo neuronal cell injection at Duke University Medical Center's neurobiology department.

 

"If we find an interesting therapeutics company, we'd be happy to put down a term sheet," Maris told the Globe.

 

Thrive's $9K in Grants Enable Five Madison, Wis.-Area Biotechs to Attend BIO 2009

Thrive, the economic development organization promoting the eight counties in and around Madison, Wis., has awarded a total $9,000 from its pilot BIO Partnering Grant program to five Madison-area life sciences companies to attend the Biotechnology Industry Organization's 2009 International Convention in Atlanta from May 18-21.

 

The five companies are: FluGen, Primorigen Biosciences, Shiloh Laboratories, Anteco Pharma, and Scarab Genomics.

 

"In the future, Thrive hopes to expand its Partnering Grant program to other events that connect companies with corporate partners and investors," said Cheryl Gain, Thrive's director of biotech initiatives, in a statement.

 

Fall River, MA Gets Support for SouthCoast BioPark

State officials unveiled $17 million in state grants Friday to build the 300-acre SouthCoast BioPark — a project they claim will bring thousands of jobs to the region.

The park's first tenant will be a University of Massachusetts Dartmouth bioprocessing facility — a building similar to the Advanced Technology and Manufacturing Center on Martine Street.

Initially dubbed the Fall River Executive Park, the SouthCoast BioPark will be located right off the proposed Route 24 interchange — a separate project estimated at $60 million that will build a ramp between exits 8 and 9.

City and state officials gathered at the future site of the BioPark Friday to announce the grants and detail some of the plans. The park will include a 1.5-million square-foot corporate campus, 10 three- and four-story office buildings and a parking garage.

Massachusetts Executive Office of Housing & Economic Development Secretary Gregory Bialecki said $2 million in grants will be used to extend Riggenbach Road to the proposed Route 24 interchange and construct an access road leading to the BioPark. The remaining $15 million will pay for the design and construction of the UMass bioprocessing facility, work which will begin immediately, Bialecki said.

Mayor Robert Correia said the projects will, in the short term, create dozens of construction jobs. The development of the BioPark will create 8,000 biomanufacturing and biotechnical jobs for a wide range of potential employees.  “It’s not often that a project allows for job growth both in the immediate future and the long-term as well,” said Correia. “The project will create thousands of decent, good-paying jobs that will affect the Fall River economy for generations to come.”

Bialecki said many people assume that development of biotechnology firms would occur solely in Boston or Cambridge or along the Route 128 corridor, but he said this SouthCoast proposal proves that to be untrue.

“This project builds on our investment in life sciences supercluster and creates long-term regional prosperity in an environmentally responsible manner,” Bialecki said.

Bialecki said he expects ground to be broken on the bioprocessing facility sometime next year.

State Rep. Michael Rodrigues, D-Westport, who has been involved in the project's planning for more than eight years, credited former Fall River Mayor Edward Lambert, and many others, for helping the initiative take shape.

“We have now taken the critical step in ensuring that the Bioreserve meets the goals we set forth in drafting the original legislation — to ensure that the SouthCoast is the best place to live, work and raise a family,” said Rodrigues, who added that more grants would become available after the bioprocessing facility’s groundbreaking.

The bioprocessing facility will help advance the state’s technical expertise in life science technology. At the core of the facility will be two large-scale suites, a purification suite, a quality control lab, a classroom and a teaching laboratory.

UMass Dartmouth Chancellor Jean MacCormack said the Fall River Redevelopment Authority will provide the university with $3 million in startup money.

“The region and the city of Fall River have targeted 'life sciences cluster' as a top priority. We expect to have a great return on this investment, but we don’t think of that return as we would if we were a business,” said MacCormack. “Our return is in the creation of a future workforce.”  

Correia said the city didn’t look to the Fall River Industrial Park as a potential home for the project because the designs for the BioPark's buildings don’t fit into any of the existing buildings or available land.

Fall River Office of Economic Development Executive Vice President Kenneth Fiola Jr. said the Fall River Industrial Park is at 99 percent capacity, with only the former 167,000-square-foot Genzyme Building on Airport Road empty.

“Two buildings just went under agreement,” said Fiola,  “and there are only 20 developable acres in the park. That’s why there’s the need to develop a park like this.”

Correia said besides UMass, there are no other tenants ready to set up shop at the areas only BioPark, but he doesn’t expect it to be that long before they come calling.

“For once in its life, Fall River will not be on the downturn of a trend. We came in on the downturn of the textile industry and we came in on the downturn on rubber, but not this time,” said Correia. “Biotechnology and Life Sciences are two of the industries of the future and we in southeastern Massachusetts are ecstatic to play a leading role here in Fall River.”

 

Campanelli Co. Breaks Ground on New IDEX Health & Science Building

Amid a sagging real estate market and in spite of a national slump in new construction, Campanelli Companies has reported a newly-signed contract to add 80,000 square feet of commercial space to the Campanelli Business Park of Middleborough. IDEX Health & Science signed the lease with Campanelli to provide turnkey services on the build-to-suit facility on the Middleboro campus, a property whose development by Campanelli Companies dates back to the 1980s and is currently home to several large companies.

 

"IDEX Health & Science solicited proposals from several master-planned industrial parks in Southeastern, Massachusetts ," said Steven Clancy, partner at CB Richard Ellis. "It was an incredibly competitive process, but Campanelli Companies was able to offer the best combination of price and development service

Breaking ground on the new IDEX Health & Science facility marked the 12th business and ninth building in the 220 acre Campanelli Business Park , which is already home to a number of established companies, including Christmas Tree Shops, Sager Electronics, Champion Exposition Services, Serta Mattress and NES Clothing Company.

 

The new facility will serve as one of IDEX Health & Science's manufacturing facilities. The company will be consolidating two facilities into the new Middleboro location.

 

The building will feature cleanrooms, office space, a manufacturing area, café and a fitness facility. IDEX Health & Science will have the ability to expand the building an additional 25 percent as needed.

 

"At a time when the challenge of credit underwriting, appraising and financing is at an all-time high and on a deal that required coast to coast approvals, we are very happy to announce that we have broken ground on this new manufacturing facility," said Jeffrey DeMarco, partner at Campanelli Companies. "IDEX is a welcome addition to the Campanelli Business Park of Middleboro, and we look forward to designing, building and servicing the very best possible facility for the firm."

 

Overall national construction starts fell 23 percent from December of 2008 to January of 2009 and an additional 6 percent in February, according to Reed Construction Data. Campanelli Companies' robust health was evident against this backdrop of an overall downward national trend in new construction: Campanelli Construction Company alone has averaged $100 million per year in recent years, and the parent firm has been in business for more than six decades, successfully passing through three generations of family ownership.

 

IDEX Health & Science designs, develops, and manufactures OEM liquid subassemblies, gas management systems, optical filters, and precision components for a range of applications requiring highly precise control and measurement. IDEX Health & Science is the synthesis of leading component and technology suppliers to the analytical instrument, diagnostics, biotechnology, industrial, and semiconductor markets.

 

Biotage Cuts to Total Around 65 as Firm Preps US Move

Biotage expects to cut around 65 jobs at its Charlottesville, Va., facilities rather than the 50 it had initially estimated when it announced the layoffs in January.

 

A Biotage spokesperson told GenomeWeb Daily News that the firm had around 75 employees in Charlottesville before the initial round of layoffs was announced. She said the cuts were being made in waves a few months apart.

 

The firm will retain around 10 employees, who will move to the firm's new US office in North Carolina in September. However, the new facility will not have any production capabilities, with employees focused on administrative tasks, distribution, and sales, she said.

 

Uppsala, Sweden-based Biotage said in January that it would move its instrument production from its current facilities in Charlottesville to an unnamed contract manufacturer. The instruments made at that facility are primarily for purification applications. A small portion of the firm's consumables also are made at the Virginia facility, but production of those products are being moved to Biotage's facility in Cardiff, Wales, which already manufactures the majority of its consumables.

 

San Diego Facility Designed by Kornberg Associates | Architects Serves as Gleaming Addition to Local Biotech Community

A new 38,000 square-foot biopharmaceutical research facility designed by Kornberg Associates | Architects has transformed an old one-story building into a modern, two-story structure featuring state-of-the-art labs, research offices and a sophisticated video conferencing room. Ken Kornberg, president and founder, made the announcement.

 

A number of city and county dignitaries attended the recent grand opening of the Ferring Pharmaceuticals facility, located in the city's Sorrento Valley area, which is home to numerous biotechnology and research institutes. The privately held Swiss company develops and markets a wide variety of pharmaceutical products and expects to launch in a few weeks a first-in-class prostate cancer drug discovered in San Diego in 1996.

 

According to Kornberg Associates | Architects Principal Mike Mulvey, who heads up the firm's San Diego operations, since the site wasn't conducive to lateral expansion and the existing structure couldn't support additional loads, a separate structure was designed that now straddles the existing labs.

 

A second-floor deck above the existing roof has been reconfigured into a semi-enclosed interstitial space that also hides all of the unsightly HVAC equipment that was on the roof.

 

"The second floor contains organic, peptide and analytical chemistry labs," Mulvey said. "Dockable lab workbenches and mobile drawer/cabinet units connect to a horizontal utility umbilical that provides configuration flexibility for the labs. The configuration also allows floor-to-ceiling glass walls that make the labs very light and allow users to enjoy views of the adjacent Penasquitos reserve."

 

Other key design features:

The site borders the Penasquitos Multiple Habitat Protection Area (MHPA) and is also subject to California Coastal Commission restrictions. Environmental reports, archaeological studies, Torrey Hills Community Planning approval and clearance from MCAS Miramar were required in addition to the usual City permits before construction could begin. As a committed good corporate citizen, Ferring made sure to do everything "by the book" before proceeding.

 

Kornberg Associates | Architects established in 1979, is the world's oldest, independent lab/research design firm. The company provides a full range of architectural services and has completed more than 500 projects worldwide. These have included pharmaceutical and biomedical research labs, clinical care facilities, medical centers, office/administrative buildings, conference centers and schools. Project scale ranges from tenant improvement/renovation to complete buildings and campuses. Offices are located in San Diego and Menlo Park, CA; and Tokyo.

 

Nutra Pharma Branches Out into Contract Services

ReceptoPharm, a subsidiary of US biotechnology company Nutra Pharma, is to start offering contract research and manufacturing services for life science companies.

 

Discussing the move, Dr. Paul Reid, CEO of ReceptoPharm, said the objective was to offer a suite of services to emerging biopharmaceutical companies, including pre-production studies, contract manufacturing services, US & EU regulatory support, and quality systems/good manufacturing practice (GMP) certification.

 

“As a clinical stage company specializing in biologics, we understand and have cleared many of the hurdles that face emerging biotech companies,” said Dr. Reid.

 

ReceptoPharm specializes in the development of drugs to treat neurological, immunological and viral conditions, and it has already advanced treatments for adreno-myeloneuropathy (AMN), HIV and multiple sclerosis into Phase I and II clinical development. It has built up particular expertise around nicotinic acetylcholine receptors, which have been linked to a number of disease states.

 

ReceptoPharm’s entry into the CRO space comes at a time when smaller contractors are coming under increasing pressure as their primary client base – small and medium-sized enterprises (SME) – are under increasing financial pressure.

 

As a result many SMEs are shelving and prioritizing early-stage drug development projects, leaving CROs competing for a dwindling number of contracts.

 

However, ReceptoPharm believes that one factor that differentiates it from many early-stage CROs is that it has established its own GMP production facility.

 

Rik Deitsch, Nutra Pharma’s chief executive, said the opening of this facility “could not have come at a better time given the current state of the economy and the reduced level of financing available for many of these early-stage companies.”

Establishing and maintaining a qualified drug production facility can represent a significant drain on a small company’s resources, according to ReceptoPharm.

“By offering these services, at a much lower cost as compared to traditional contract research organizations, ReceptoPharm allows these life science firms to immediately continue innovating and developing medical technologies, instead of waiting for the economy to fully recover.”

The company can also prepare and sterile fill pharmaceutical products in its ISO Class 5 cleanroom facilities for trials in the US and the EU.

 

Catalent Changes

Catalent is adjusting its packaging operations by closing one facility and simultaneously expanding another, which it believes will improve the service offered to its folding carton customers.

The move will allow Catalent to focus its US printed components operations on its more modern Moorestown, New Jersey facility, which will benefit from additional new equipment and technologies to perform this expanded role.

 

Moorestown’s expansion comes at the cost of Catalent’s Pennsauken, New Jersey facility, which will close in August 2009 to allow the company to gain the benefits of operating from a single location.

 

Victor Dixon, Catalent's vice president and general manager, printed components, said: "We believe housing our continental US printed components business in a single location will bring important benefits for our customers, including more efficient distribution, a consolidated invoice, and the ability to pack or 'kit' all products, including labels, inserts and cartons, together.”

 

To ensure its Moorestown facility is equipped to handle this increased workload Catalent is installing an array of new equipment and transferring some machinery from the Pennsauken site.

 

Moorestown’s new and upgraded equipment will include UV coating, vision systems, additional printing technologies and the establishment of a new design and pre-press centre.

 

The site will also benefit from Catalent’s new e-Magineering system, which is a web-based method for automating the development, management and delivery of printed labels, inserts and cartons.

 

e-Magineering covers these steps from the design phase through to supply replenishment, with the system also tracking document work flow, order history and billing.

 

Catalent has been keen to emphasize the benefits this shift in operations will bring to clients but has also stressed that it will attempt to mitigate the effects felt by employees at the Pennsauken site.

 

Dixon said: "Closing our Pennsauken plant was a difficult but necessary step in the evolution of the business, and we are dedicated to supporting efforts to help the employees that will be affected by the closing.”

 

REST OF World

 

UK's New £13.5M Genome Analysis Centre Eyes June Opening at Norwich Research Park

The UK's Biotechnology and Biological Sciences Research Council announced last week that its £13.5 million ($20 million) Genome Analysis Centre focused on analysis of plant, microbial, fish, and farm animal genomes will become operational over the next two months and will be formally opened in June at Norwich Research Park.

 

TGAC will provide genome sequencing to underpin advances to improve food security, to protect UK agriculture from exotic animal disease, and to exploit weaknesses in microbes to develop new ways to kill superbugs. The new center will also serve as a center of excellence in bioinformatics. The center will be run by a business development director that BBSRC said it had yet to hire.

 

BBSRC said in a statement it is providing the majority of the funding needed for TGAC, and will underwrite its running costs for several years. Additional money for the center will come from the East of England Development authority, Norfolk County Council, South Norfolk Council, Norwich City Council, and the Greater Norwich Development Partnership.

 

Funding for TGAC was delayed last fall when the Norfolk County Council postponed to November its plan to award a £1 million grant toward the center. The council held off pending more information on its losses on a £32.5 million investment in three Icelandic banks that failed as part of that nation's financial crisis last September.

 

Shasun Chemicals Shuts Pharmaceutical Manufacturing Plant in Scotland

Indian-owned Shasun Chemicals shut down its Shasun Pharma Solutions pharmaceutical manufacturing plant near Annan, Scotland, almost six months after saying that the facility was "underused" and could not be sustained, according to Outsourcing-Pharma.com

 

The plant's 86 employees lost their jobs following the shutdown of the plant in Newbie. The facility offered custom development and manufacturing services to pharmaceutical and biopharmaceutical customers, and was one of two facilities operated by Shasun in the UK. The other facility, in Dudley, Northumberland, continues to provide pilot- to commercial-scale production of APIs and intermediates.

 

Shasun conducted research in India, and built up its capacity for development and manufacturing — at kilo laboratory and pilot plant scale — that could be conducted either in the UK or India. The company's UK operation suffered a setback last year, when Shasun announced plans to invest in a process development facility in Piscataway, NJ, following operational problems at the Annan facility that impacted Shasun's 2007 financial results.

 

A team of 30 staff will stay on at Newbie until June to dismantle the facility. Shasun Pharma Solutions President Kevin Cook has said the company is speaking to a potential buyer interested in maintaining pharmaceutical manufacturing at the plant.

 

Aoxing Plant in China Gets GMP OK

China Aoxing Pharmaceutical, a specialist developer of pain management drugs, has received GMP accreditation for the new tablet production and packaging plant it has set up in Shijiazhuang.

 

The facility, which has been cleared by the State Food and Drug Administration (SFDA) for five years, will produce solid dose versions of narcotic painkillers like oxycodone and buprenorphine for the Chinese market.

 

The plant will also make the powerful narcotic pain management product tilidine, which Aoxing became one of the few manufacturers licensed to manufacture for the Chinese market in 2007.

 

Aoxing CEO Juan Yue Han said that the accreditation provides the foundation for the further development and strengthens the firm’s manufacturing base, positioning it for growth in China’s expanding drug market.

 

Since the SFDA began tightening up rules on drug production in 2006 the number of Chinese drugmakers that have gained good manufacturing practice (GMP) accreditation has increased considerably.

 

However, Aoxing claims that its facility is one of very few in China to have been cleared for the production of narcotic drugs, which necessarily require stricter control than other medications.

 

The company went on to say that the lack of manufacturing capacity, coupled with increasing demand for western pain medicines, means that the Chinese narcotic painkiller market is both “very under-served and fast-growing.”

 

Aoxing said it is working closely with the government and SFDA to ensure the strictly regulated availability to medical professionals of its narcotic drugs and pain medicines throughout China.

 

In addition, while Aoxing did not reveal any plans to make drugs for the export market, gaining GMP accreditation from the SFDA will certainly make it easier for the firm to gain similar approval from regulators outside the country in the future.

 

GVK — Excel Alliance Reaches from India to China

Companies seeking research services in India and China will now be able to use a single contact following an alliance between GVK BIO and Excel, which the companies claim is the first to span the two nations.

 

The cost-effectiveness of both countries and their respective specializations, such as India’s sponsor friendly regulations and China’s large market, have been cited by the companies as the motivation for the alliance.

 

By harnessing the respective strengths of each country and company, India-based GVK Biosciences and China-based Excel PharmaStudies believe they can quickly and efficiently move clinical trials from Phase II to IV.

 

Manni Kantipudi, president of GVK BIO, said: “This is a first of a kind alliance between an Indian contract research organization (CRO) and a Chinese CRO. The GVK BIO-Excel alliance integrates trial management across India and China and provides sponsors with a single point of contact.”

 

Under the terms of agreement GVK BIO and Excel will assist sponsors with Phase II to IV trials, statistical analysis and medical writing.

 

The arrangement between the two companies is that any of GVK BIO’s trials that take place in China will be carried out by Excel and managed by the Indian company. Similarly, Excel will manage its trials in India and they will be performed by GVK BIO.

 

GVK BIO’s alliance with Excel comes three weeks after it gained approval from the Turkish Ministry of Health to conduct bioequivalence studies, which opens up the country’s generic drug market to the Indian CRO.

 

Having gained approval GVK BIO will be able to conduct bioequivalence studies at its clinical pharmacology sites in Hyderabad, India for clients looking to market generic drugs in Turkey.

 

LGC Opens Office in China to Raise Local Lab Standards

LGC Standards is increasing its presence in Asia through the opening of its first office in China, which will provide laboratory quality management services to the local market.

By opening an office in China the UK-based company will allow it to directly support the growing local pharmaceutical laboratory network, providing technical and logistical advice in the local language.

 

LGC has offices throughout Western Europe and representatives in Central and Eastern Europe, the US and joint-venture in India and has now identified China as the next location for its international expansion.

 

Matthias Brommer, director of LGC Standards, said: “The opening of our first Chinese office clearly demonstrates that LGC Standards is committed to providing global quality management solutions for laboratories worldwide.

 

“Our Chinese team will focus on supplying laboratories in the pharmaceutical, environmental, food, industrial and forensic sectors with reference materials and proficiency testing schemes to support laboratory quality.”

 

From the office LGC will provide a range of products and services for measurement and laboratory control, such as reference materials and proficiency testing.

 

LGC believes that by improving the supply of reference materials and proficiency testing schemes to Chinese laboratories it can help the country meet international standards.

 

In addition LGC has indicated that it is keen to partner with local businesses on future projects and will use the office as a base for establishing these relationships.

 

The office will be managed by Chen Hong, with Frank Lai joining the company to provide specialist pharmaceutical knowledge.

 

French Drug Maker Sanofi to Buy Brazil's Medley

French drug maker Sanofi-Aventis SA announced that it is buying Brazilian pharmaceutical company Medley for 1.5 billion reals (euro500 million, $662 million), as reported by the Associated Press. Medley is Brazil's third-largest pharmaceutical company with annual sales of 458 million reals, Sanofi-Aventis said in a statement. Medley is the country's No. 1 maker of generic medicines with a portfolio of 127 products, from where it gets two-thirds of its sales. Paris-based Sanofi-Aventis said it expects the market for non-patented drugs to grow by 20 percent a year. The deal should be completed before the end of June, Sanofi-Aventis said. 

 

China Looks to Expand Stake in Stem Cell Technology

According to Reuters, China’s health minister has announced plans to build Asia's biggest base to develop uses for stem cell medical technology. Stem cell techniques use the body's master cells to create new cells that medical researchers hope can be used to fight diseases and heal injuries. Chinese Health Minister Chen Zhu said his country could become a leader in finding uses for the technology. China is looking to expand its stake in this increasingly competitive area, where it has few of the regulatory controls and controversies that have constrained research elsewhere. Former U.S. President George W. Bush and some religious conservatives have opposed the use of stem cells taken from human embryos. But U.S. President Barack Obama has reversed Bush's policy that virtually froze federal funding for stem cell research using embryonic samples. China's base will be in Taizhou, an area of Jiangsu with many medical and pharmaceutical businesses, and will cover 20,000 square meters and include a clinic, said the report. There was not an estimate for when the project would be completed. Singapore is also looking to emerge as a regional center for the technology. 

 

New Training Facility at University in Holbeach, UK to Drive Food Sector Innovation

A recently opened UK university based food packaging and processing training factory, supported by equipment manufacturers and organizations, is aimed at food sector employees.

 

The £3.5m National Centre for Food Manufacturing at the University of Lincoln’s Holbeach campus will offer training opportunities from tailored short courses to degree programs for staff at all levels in the food processing industry, claims its Dean, Val Braybrooks.

 

She said that the Centre will also support the university in its efforts to further research and innovation in the area of food packaging and processing automation.

Braybrooks argues that the Centre is innovative in that its provision has been shaped and dictated by food companies in the region who have been working together to support the facility.

 

The training factory, she added, has state of the art equipment provided by industry suppliers including a £1.5m fully automated production line for ready meals, gas analysis equipment for modified atmosphere packing (MAP) as well as packaging coding and dating equipment, a sauce depositor, ultra-violet technology and a fork lift truck.

 

Stuart Rose, executive chairman of UK supermarket chain, Marks & Spencer, officially opened the facility, and he claims that “Holbeach will ensure a steady flow of trained professionals into the food manufacturing industry, enabling companies …to benefit from continual innovation from our suppliers.”

 

In light of growing interest in devising sustainable, cost-efficient pack and processing solutions, academic institutions are increasingly being supported and sought after by companies and retailers to find potential operational benefits.

 

UK-based retailer Tesco recently announced it was working with one veterinary university in England in a bid to encourage greater academic collaboration over supply chain challenges.

 

Groups like packager Sealed Air also announced a similar team up last year with South Carolina-based Clemson University to create a teaching, research and service facility.

 

And Coca-Cola has provided $400,000 to one US-based university to encourage development of new sustainable forms of packaging through a scheme that could see other beverage and food manufacturers following suit.

 

The funding will be used to support a proposed Packaging Innovation and Sustainability Centre at Michigan State University (MSU), which has been devised to focus on evaluating pack sustainability from a scientific perspective.

 

Susan Selke, acting director of MSU’s School of Packaging, said that the centre was seeking further support from other commercial groups both in terms of initial and longer-term support that it hopes could come, in part, from the beverage industry.

 

Moreover, greener brewing and wine production is on the syllabus at the University of California as construction begins on a new Winery, Brewery and Food Science Laboratory on the campus from June.

 

With completion of the 34,000-square-foot research centre expected by 2010, the university claims that the complex will provide scientific research, student training and even collaboration with industry.

 

Piramal Moves UK API Operations to India

Piramal Healthcare is switching its UK API making operations to Morpeth, Nothumberland after a downturn in the Indian CMO’s international business cut capacity utilization at its former base in Huddersfield to just 35 per cent.

 

The firm gained control of the Huddersfield plant in 2005 through its £10m (€11m) acquisition of Avecia Pharmaceuticals in December 2005. Pirmal plans to shut down the facility, which contributed £19m to its earnings last year, but has not yet said whether it is seeking a buyer.

 

The move, which will result in the loss of 93 jobs and cost Piramal around £10m, will split the Huddersfield plant’s roster of manufacturing contracts between the Morpeth plant and facilities in Ennore and Ahmedabad in India.

 

Piramal said that the move will improve margins in its Pharma Solutions Business (PBS) by between 6 to 8 per cent over the next two years, according to a report in India’s Business Standard

 

CEO Ajay Piramal told the paper that Piramal’s international business will shrink by around 5 per cent this year but predicted that this will be more than offset by a 15 per cent expansion of its Indian operations.

 

He added that although the global downturn has cut spending by its smaller customers, a greater number of contracts from a Big Pharma sector keen to reduce manufacturing costs would drive growth of the firm’s business in India.

 

The Morpeth facility, which houses active pharmaceutical ingredient (API) and finished dosage manufacturing capacity as well as clinical packaging and distribution units, was purchased from global drug giant Pfizer in June 2006.

 

The plant is approved by both the US Food and Drug Administration (FDA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA), employs a staff of 450 and already has a $350m (€260m) supply contract with Pfizer.

 

Piramal has again denied it is in talks with France’s Sanofi Aventis about a potential takeover after a series of rumors linked the two firms, according to a report in India’s Economic Times.

 

As recently as last month Piramal described reports that it was in talks with the European giant as “unfounded,” adopting a similar stance to the one it took in February when speculation named GlaxoSmithKline (GSK) as a potential suitor.

 

Piramal’s desire to remain independent was leant further credence with the installation of Nandini Piramal, daughter of the current CEO, as an executive director.

 

Mr. Piramal told India’s Financial Chronicle that: “I am strengthening the top management of the company. My daughter will now take up more responsibilities. My son will also get a similar role once he completes his MBA.”

 

While reorganization of Piramal’s UK operations is not likely to impact on any buyout decision, the plan to shift more business to India does fit with the desire of Big Pharma in general, and Sanofi in particular, to focus on growth in emerging markets.

 

ReSearch Pharmaceutical Services Expanded Asian Market Via the Purchase of Chinese Contract Research Organization (CRO) Paramax International

Delaware, US-based RPS will pay around $1m in cash as well as around 531,000 shares to gain control of Paramax.

 

The move will give RPS expanded capabilities in the Asian market, said RPS, which has already expanded from the US into Europe and Latin America in the last couple of years.

 

RPS first started a push to internationalize its business in 2006/2007 with an expansion into Latin America, and followed it up in 2008 with a push into Europe. Last December, RPS bought France’s Therapherm Recherches, Imerem of Germany and Spanish CRO Infociencia for a total of €7.4m, plus stock. The company says 2009 will mark its expansion into Asian markets.

 

“The acquisition of Paramax will be a key event in the expansion of our existing operations for providing globally integrated clinical research services,” commented RPS’ chief executive Dan Perlman.

 

Paramax, set up in 2003, represents the first phase of that expansion. The company has headquarters in Beijing and an operations office in Shanghai which will serve as RPS’ Asian headquarters.

 

Chinese CRO Has Stake in Good Laboratory Practice (GLP) Certified Laboratory at the Second Military Medical University (SMMU) in Shanghai

The Chinese CRO Paramax has a stake in a Good Laboratory Practice (GLP) Certified Laboratory set up with China’s Center for Evaluation of Drug Safety at the Second Military Medical University (SMMU) in Shanghai.

 

It specializes in toxicology and pharmacology studies, clinical monitoring, patient recruitment and clinical data management and biostatistics. Paramax also offers consulting, regulatory affairs, project management and medical writing services.

 

Preclinical CRO Porsolt Expands in France, U.S.

Porsolt, a French contract research organization (CRO) specializing in preclinical pharmacology services, has said it plans to open a new facility in Europe as well as boost its presence on the other side of the Atlantic.

 

The CRO has started construction of a new laboratory on a 10-hectare development in Laval, France. The first phase of the operation will see a 60,000 square foot facility completed in early 2010.

 

The new site will offer increased capacity for Porsolt's expanding cross-therapeutic area models and Good Laboratory Practices safety pharmacology expertise, according to the firm.

 

Porsolt’s chief executive, Mark Duxon, said the decision follows a period of good growth in 2008, and a growing awareness of the firm’s “cross-therapeutic area expertise,” which he believes has set the firm up for “sustained growth in the next five to 10 years.”

Porsolt has remained very focused on its core expertise – preclinical pharmacology – at a time when many CROs have pursued a strategy of broadening their service range in the hope of winning lucrative ‘preferred provider’ contracts.

 

The French CRO believes that concentrating on two core services - assessing novel substances for therapeutic activity and safety using animal models – is a more reliable model. The company has long argued that the best strategy is not to strive to become the biggest CRO, but to remain the best in selected areas of competence.

 

While the company is happy to remain a specialist service provider, it is keen to expand its geographic presence and has implemented a project to spearhead an expansion in the US.

 

Porsolt has hired two experienced PhD biologists from Big Pharma who will be permanently based in the USA to conduct business development support in that country.

 

The headcount in the US business development group will be further increased - in line with expansion of the company - in 2009 and 2010, the CRO noted. Porsolt already has a team of five business development staff located in Paris, France.

 

Martine Lemaire, senior director and head of business development, commented: "as our laboratory services grow and as we implement a new expansion strategy, we feel it is essential to have experienced personnel based in the US to offer direct face-to-face client interaction. “

 

Nutra Pharma Branches Out into Contract Services

ReceptoPharm, a subsidiary of US biotechnology company Nutra Pharma, is to start offering contract research and manufacturing services for life science companies.

 

Discussing the move, Dr. Paul Reid, CEO of ReceptoPharm, said the objective was to offer a suite of services to emerging biopharmaceutical companies, including pre-production studies, contract manufacturing services, US & EU regulatory support, and quality systems/good manufacturing practice (GMP) certification.

 

“As a clinical stage company specializing in biologics, we understand and have cleared many of the hurdles that face emerging biotech companies,” said Dr. Reid.

 

ReceptoPharm specializes in the development of drugs to treat neurological, immunological and viral conditions, and it has already advanced treatments for adreno-myeloneuropathy (AMN), HIV and multiple sclerosis into Phase I and II clinical development. It has built up particular expertise around nicotinic acetylcholine receptors, which have been linked to a number of disease states.

 

ReceptoPharm’s entry into the CRO space comes at a time when smaller contractors are coming under increasing pressure as their primary client base – small and medium-sized enterprises (SME) – are under increasing financial pressure.

 

As a result many SMEs are shelving and prioritizing early-stage drug development projects, leaving CROs competing for a dwindling number of contracts.

 

However, ReceptoPharm believes that one factor that differentiates it from many early-stage CROs is that it has established its own GMP production facility.

 

Rik Deitsch, Nutra Pharma’s chief executive, said the opening of this facility “could not have come at a better time given the current state of the economy and the reduced level of financing available for many of these early-stage companies.”

 

Establishing and maintaining a qualified drug production facility can represent a significant drain on a small company’s resources, according to ReceptoPharm.

 

“By offering these services, at a much lower cost as compared to traditional contract research organizations, ReceptoPharm allows these life science firms to immediately continue innovating and developing medical technologies, instead of waiting for the economy to fully recover.”

 

The company can also prepare and sterile fill pharmaceutical products in its ISO Class 5 cleanroom facilities for trials in the U.S. and the EU.

 

Final Curtain for India’s Shasun in Scotland

India’s Shasun Chemicals officially closed its pharmaceutical manufacturing plant near Annan in Scotland, a little under six months after saying that it was ‘underused’ and could not be kept on as a going concern.

 

A total of 86 staff lost their jobs as a result of the closure. Last October, Shasun said the UK facility – which operated as Shasun Pharma Solutions Ltd (SPSL) - would be shuttered and products manufactured at the site would be relocated to alternative locations.

 

The site, at Newbie, offered custom development and manufacturing services to the pharmaceutical and biopharmaceutical industries, and was one of two facilities operated by Shasun in the UK. The other is in Dudley, Northumberland, and is still operating, providing pilot to commercial-scale production of APIs and intermediates.

 

Shasun aligned its facilities so that research would be conducted in India, while development and manufacturing at kilo laboratory and pilot plant scale could be conducted either in the UK or India. That has made it easier to take the tough decision to rationalize production.

 

The prospects for further development of the UK operation were dealt a blow when Shasun announced plans to invest in a process development facility in Piscataway, New Jersey, US, in January 2008. That came on the back of operational problems at the Annan facility that impact Shasun’s 2007 financial results.

 

A team of 30 staff will stay on at Newbie until June to dismantle the facility, and the hope is that a buyer may still come in and buy the plant.

 

According to SPSL president Kevin Cook, who told local press that at the moment a buyer interested in maintaining pharmaceutical manufacturing at Newbie is still in the running.

 

Catalent Sells French Solid Dose Plant to Bavaria’s Industriekapital

US contracting giant Catalent Pharma Solutions has sold its manufacturing unit in Osny, France to Germany’s Bavaria Industriekapital.

 

Located just north of the French capital Paris, the good manufacturing practice (GMP) approved facility is fitted out for the production of active pharmaceutical ingredients (APIs), oral forms and non-sterile oral liquids.

 

Cornell Stamoran, Catalent’s VP of strategy and corporate development, told Outsourcing-Pharma that: “Shortly after the separation of Catalent from Cardinal Health in mid-2007, we reached a decision that Osny's specialised capabilities were not well aligned with the future of Catalent.”

 

He stressed that Catalent “remain[s] optimistic about the future prospects for outsourcing for advanced dose forms, such as our liquid filled softgels and Zydis fast dissolve tablets, where a majority of our oral technologies segment business is concentrated today.

 

Stamoran added that, in Catalent’s view, the specialised manufacturing and handling know-how offered by both its modified-release oral dose plant in Winchester, Kentucky and the Osny site under Bavaria’s ownership “will continue to meet specific niche needs of the global pharma industry, for both branded and generic products.”

 

The Osny unit, which was renamed Osny Pharma SAS when the deal closed on March 31, is expected to retain its workforce and customer base.

 

In a press statement Catalent’s VP of modified release technologies, Ian Muir, said that: “We are pleased that Bavaria has acquired this business, as we believe they, along with the strong local team in place, will continue to provide the facility’s customers the high degree of quality and compliance they have received in the past.”

 

These thoughts were echoed by Bavaria’s managing director, Hans Magnus Andresen, who said that the firm is very excited about the acquisition. He explained that the company had been very impressed by the management and operating teams at Osny.

 

Andersen added that: “[the] site will focus strongly on keeping its loyal customer base satisfied and continuously optimize its production processes without losing its keen eye on delivering top quality products.”

 

Catalent and Siga Develop Process for Anti-Smallpox Drug

In other Catalent news, the firm was named by US drug developer Siga Technologies as a key partner in developing the manufacturing process for its new anti-bio-warfare product ST-246.

 

The two firms made three pilot batches of the anti-smallpox product ST-246 comprising a total of 350,000 capsules, equivalent to around a tenth of the commercial scale manufacturing runs that Siga is planning.

 

Eric Rose, Siga’s CEO, commented, "SIGA has achieved another major step required by the FDA before commercializing ST-246,” adding that "many people worked hard at SIGA and Catalent to achieve this goal.”

 

Takeda to Move R&D Base to Illinois

Takeda Pharmaceutical Co., Japan's biggest drug maker, will move its global research and development headquarters across the Pacific to Illinois.

 

The shift is part of Takeda's midterm plan, through which it seeks to boost its global operations and introduce new products ahead of the 2011 patent expiration of its hit diabetes drug Actos.

 

The R&D transfer from Osaka, western Japan to its facility in Deerfield, Ill. will be completed by July 1, the company said.

"Takeda is making meaningful changes in structure and governance through this reorganization ... which we believe will further strengthen our global operations structure," said President Yasuchika Hasegawa in a statement.

 

The Japanese drug maker stands to lose substantial revenue after Actos expires and has been working to develop new drugs to fill the looming hole.

 

Earlier this month, the company hit a roadblock when the Food and Drug Administration said that the existing clinical data for its new diabetes drug SYR-322, known as alogliptin, was not sufficient. The FDA says it will rule on the drug by June 26.

 

 

McIlvaine Company,

Northfield, IL 60093-2743

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