Previous Issues

by Patti Charek

Xcellerex Announces Groundbreaking for New State-of-the-Art Biomanufacturing Facility

Xcellerex, Inc. announced that it has begun construction of a state-of-the-art cGMP FlexFactory® biomanufacturing facility at its headquarters location in Marlborough, MA. Construction will be completed in September 2010. The facility, the second FlexFactory at the company's headquarters, will expand Xcellerex's capacity to provide bridge biomanufacturing services for clients that are planning or building their own FlexFactory facilities. The plant will also support Xcellerex's contract manufacturing operations.

The new facility will feature 2,000 liter Xcellerex XDR single-use bioreactors and modular single-use downstream unit operations through bulk-product. Xcellerex President and CEO Guy Broadbent commented, "This facility represents an important milestone for Xcellerex..." Xcellerex founder and Chief Technology Officer Parrish Galliher added, "This new FlexFactory facility...will be a great case study, demonstrating the power of the FlexFactory capability. We will achieve new working capacity in less than six months, at a fraction of the cost required for a conventional facility. This will also give us a hands-on educational tool to help prospective customers achieve a deeper understanding of how a FlexFactory operates." (Source:  Xcellerex Website, 9 June, 2010)

Xcellerex and Collaborators Demonstrate Rapid Production of Swine Flu H1 Hemagglutinin

Xcellerex, Inc. and Pfenex Inc. announced that the companies, along with deltaDOT Ltd. and BioPharm Services have successfully demonstrated the production of purified swine flu H1 hemagglutinin (California strain) in 42 days starting from the amino acid sequence of the protein. During that period, the gene was cloned and expressed, fermentation and purification processes developed, and the quality product shown to be fully within the specifications set out by the Defense Threat Reduction Agency (DTRA) under its Accelerated Manufacturing of Pharmaceuticals contract.

The test followed completion of 24-month, $19 million Phase 1 and Phase 2 contracts funded by both the Defense Advanced Research Projects Agency (DARPA) and the DTRA Transformational Medical Technologies Initiative (TMTI). The contracts are part of a government effort to support development of advanced manufacturing technology to address pandemic or biosecurity threats. The test results exceeded the goal for rate of production by at least 10-fold and exceeded all product quality specifications.

The test demonstrated the speed and capability of the platform in producing a real-world vaccine, in this case swine flu H1, within 12 weeks of receipt of an unknown target amino acid sequence. The team succeeded in developing a strain and bioprocess, and fully characterizing the purified product in less than six weeks and at a cost, that (scaled to manufacturing) would be less than $0.50/dose. (Source:  Xcellerex Website, 17 May, 2010)

Regulatory Affairs Workload at Drug Development Firms Shows Dramatic Increase

A growing volume of global drug development and commercialization activity during the past decade has dramatically increased the workload for regulatory affairs professionals at pharmaceutical and biotech companies, according to a study recently completed by the Tufts Center for the Study of Drug Development. The study, the first systematic assessment of global regulatory affairs performance, found that the regulatory affairs function within drug development companies has grown steadily, with most departments tending to hire from within. This comes at a time when a growing number of those companies are outsourcing more of their clinical trial work to external service providers. Findings from the Tufts CSDD analysis were reported in the March/April Tufts CSDD Impact Report.

"As more of the clinical function continues to be outsourced, regulatory affairs personnel will need to coordinate closely and communicate with external service providers. They will be challenged to handle a growing workload as their companies seek to improve R&D efficiency in an operating environment marked by ever-rising costs," said Tufts CSDD Senior Research Fellow Ken Getz, who conducted the study.

Based on data from mid-size and large pharmaceutical and biotechnology companies with global drug development operations, the study also found that:

• Regulatory affairs functions support, on average, 100 major projects per year, two-thirds of which are in clinical research phases.
• On average, 39 percent of regulatory staff has more than 10 years of experience. This compares to 9 percent for clinical staff.
• Annual average internal staff turnover for regulatory affairs groups was 6.5 percent, compared to 21 percent for clinical groups.
• Companies report that only 5 percent of staff are contract employees, who are engaged most frequently in connection with dossier compilation. (Source: Center for the Study of Drug Development, 11 March, 2010)

New Approaches to R&D May Prove Best Path for Drug Developers

Innovative approaches to drug development, including alliances and partnerships, may prove the best way to increase the rate at which the research-based drug industry brings new products to market, according to a panel of pharmaceutical and biotech industry leaders recently convened by the Tufts Center for the Study of Drug Development.

Because patents on dozens of drugs are due to expire within the next few years - paving the way for generics to compete with those products - drug developers are in a race to develop and win market approval for new medicines. "No one has yet figured out how to reliably identify early on which newly discovered compound will bear fruit," said Tufts CSDD Director Kenneth I Kaitin. "This is spurring companies across the industry to experiment with a growing range of new tools and approaches to weed out unpromising drug candidates earlier, speed development, and reduce development costs."

According to Tufts CSDD, drug development, which starts in discovery and may involve examining many thousands of compounds, takes an average of 15 years to produce a product approved for sale in the US. Industry executives, who convene several times a year at the Tufts CSDD Executive Forum Roundtable, noted that while a growing number of drug companies are developing alliances with external service providers, those approaches have not yet emerged into full-fledged partnerships, where both parties share development risks and rewards. The executives also agreed that the following new approaches, among others, may help increase R&D efficiency:

• Reducing distinctions between phases -Traditional distinctions between clinical phases is a matter of practice and not a legal requirement. Starting human trials earlier may offer a way to save money and time.
• Engaging in collaborative relationships - Agreements between sponsors, similar to the formation of the Asian Cancer Research Group, Inc. announced by Eli Lilly, Merck, and Pfizer in February, may help accelerate research.
• Using exploratory INDs - This relatively new type of pre-Phase I clinical trial lets sponsors evaluate up to five chemical entities or formulations simultaneously to identify a lead compound.

Upcoming Tufts CSDD Executive Forum Roundtable meetings in 2010 will focus on the following: Outsourcing Strategies Across the Value Chain (Sept. 16) and Strategies for Optimizing the Drug Development Process (Nov. 4). To learn more, call 617-636-2170. (Source:  Center for the Study of Drug Development, 6 April, 2010)

Rising Clinical Trial Complexity Continues to Vex Drug Developers

Growing clinical trial complexity continues to challenge the ability of pharmaceutical and biotechnology companies to contain the ever-rising cost of developing new drugs, according to a study recently completed by the Tufts Center for the Study of Drug Development. The study found that the median number of procedures per clinical trial increased by 49 percent between 2000-03 and 2004-07, while the total effort required to complete those procedures grew by 54 percent. The new study updates an analysis conducted by Tufts CSDD two years ago, which provided the first quantitative assessment of the impact of protocol design on clinical trial performance.

"More complex and burdensome protocols are extending study cycle times, increasing costs, and challenging patient recruitment and retention," said Tufts CSDD Senior Research Fellow Ken Getz, who conducted the study. "Wide observed differences in complexity and execution burden by phase and therapeutic area indicate that pharmaceutical and biotechnology companies can target their efforts to improve protocol design and improve clinical trial operating performance."

According to Getz, the rise in the number of eligibility criteria used to screen volunteers has contributed to a decline in volunteers enrolling in clinical trials. And once volunteers enroll, he said, the larger number of procedures per protocol is dissuading study volunteers from staying in trials through to completion.

The new analysis, reported in the May/June Tufts CSDD Impact Report, also found that:

• Wide variability exists in complexity and execution burden per protocol between therapeutic areas and clinical study phases, indicating opportunities to streamline design.
• Between 2002 and 2007, protocols targeting diseases in oncology, immunology, and the central nervous system saw the most rapid growth in the total number of procedures and in the burden to execute those procedures.
• Overall growth in complexity and execution burden grew at the slowest rate for protocols in Phase III studies, as companies, looking to contain costs, gathered more data in early phases of clinical research. (Source: Center for the Study of Drug Development, 5 May, 2010)

Dyax Corp. Sells Rights to Xyntha Royalties to Paul Capital Healthcare for $12M

Dyax Corp. has sold its rights to royalties and other payments related to the cmmercialization of Xyntha by Pfizer, Inc., a licensee under the company's phage display Licensing and Funded Research Program (LFRP), to an investment fund managed by Paul Capital Healthcare. Under the terms of this sale, Dyax received an upfront cash payment of $10 million and will be eligible to receive milestone payments totaling up to $2 million based on Xyntha sales in 2010 and 2011. A portion of the upfront cash payment was applied to Dyax's debt obligations under the LFRP and, net of this and other required payments, Dyax received approximately $6.8 million, exclusive of potential future milestone payments.

Xyntha, marketed as ReFacto AF in Europe, is a recombinant factor VIII product for patients with hemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis. The peptide ligand, used in the purification process during the manufacture of Xyntha, was discovered by Dyax using its proprietary phage display libraries. Xyntha is distinguished as the only recombinant factor VIII treatment to utilize an entirely synthetic purification process.

The LFRP provides access to the Dyax's phage display libraries in various types of licenses and collaborations. Dyax maintains more than 70 ongoing license agreements with various research, biotechnology and pharmaceutical companies under the LFRP. To date, licensees have advanced 17 product candidates into clinical development and one product (Xyntha) has received market approval.  (Source:  Business Wire, 20 April 2010)

Genzyme and Carl Icahn Reach Agreement

Genzyme Corporation and Carl Icahn and certain of his affiliated private investment funds recently announced an agreement to settle their proxy contest. Under the agreement, the Icahn funds will withdraw its slate of four nominees for Genzyme's board of directors and vote its Genzyme shares in favor of the company's nominees, and Genzyme will appoint Steven Burakoff, M.D., and Eric Ende, M.D., to serve as directors immediately following its annual meeting of shareholders.

Dr. Burakoff, one of the Icahn Funds' nominees, is Professor of Medicine, Hematology and Medical Oncology at the Mount Sinai School of Medicine and Director of the Tisch Cancer Institute at the Mount Sinai Medical Center. Dr. Ende, a participant in the Icahn funds' proxy solicitation, is a former biotechnology analyst with Merrill Lynch.

"Over the past year, we have made substantial progress in enacting operational and organizational changes to return to our historical path of sustainable growth," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "This agreement provides a pragmatic and constructive solution that allows us to focus on continuing to strengthen and build the company to create value for our shareholders."

Carl Icahn said: "I am always pleased when a proxy fight can be avoided. I believe Drs. Burakoff and Ende will add significant medical and financial expertise to the Genzyme board. I am also very heartened that the Genzyme board recently brought on Ralph Whitworth, a longtime activist, as a director, and announced that Dennis Fenton will shortly be added to the board as well." Mr. Icahn went on to say that the addition of these four directors represents a good outcome for shareholders, who are now better represented on Genzyme's board. "New oversight at the director level will help this great company achieve its full potential," said Mr. Icahn.

Genzyme's board currently consists of ten members, all of whom have been nominated for re-election at the company's annual meeting. Following the appointment of Drs. Burakoff and Ende and Dennis M. Fenton, Ph.D., former executive vice president of operations at Amgen Inc., the company's board will consist of 13 members. (Source:  Genzyme Website)

Philips and RXi Pharmaceuticals Sign Joint Research Agreement

Royal Philips Electronics and RXi Pharmaceuticals announced that they have entered into a joint research agreement to explore the benefits of combining proprietary technologies from both companies for the targeted delivery of experimental therapeutics based on RNA interference (RNAi).

Compounds based on RNAi represent a promising new class of drugs for the targeted treatment of a number of diseases including cancer and cardiovascular disease. Currently, however, one of the greatest challenges in developing RNAi-based therapeutics is finding ways to deliver them to their target while keeping them fully active. The joint research program between Philips and RXi will address this challenge by exploring, in preclinical studies, the possibility of using RXi's sd-rxRNA (self-delivering rxRNA) in conjunction with Philips' ultrasound technology to achieve the targeted delivery and monitoring of RNAi-based compounds in cells.

"The most important technological challenges that need to be addressed in order to realize the promise of RNAi-based approaches to treating various human disorders are efficient and safe delivery of the RNAi compounds to the targeted organs, and uptake of these compounds by relevant cells," said Noah D. Beerman, President and CEO at RXi. "By combining RXi's proprietary sd-rxRNA molecules, which have unique properties of ‘self delivery,' and Philips' ultrasound technologies, we will be working together to achieve targeted and specific delivery to relevant organs and tissues, which could potentially boost the efficacy of RNAi-based disease treatments."

Diseases, as well as their potential cures, are associated with specific processes at a cellular and molecular level. RNAi technology is a breakthrough in understanding how genes are turned on and off and represents a new approach to drug development. Therapeutics that leverage this breakthrough technology can potentially target the cause of specific diseases by silencing harmful genes and preventing disease-causing proteins being produced.

To realize this potential, it is important to first optimize RNAi compounds in a way that confers them with the required drug properties and second to enhance their delivery to cells that express these harmful genes. RXi's proprietary rxRNA molecules are chemically modified to provide them with important properties such as stability in biological fluids, low stimulatory effect on the immune system and high target specificity. Philips' image-guided ultrasound-mediated drug delivery platform offers researchers a unique approach to investigating the delivery of various therapeutic molecules across blood vessel barriers and facilitating their uptake in cells. It capitalizes upon Philips' existing expertise in medical imaging technologies for diagnosis, therapy planning and minimally-invasive medical procedures. (Source:  Business Wire, 3 June, 2010)

NIH Approves Advanced Cell Technology's Stem Cell Line for Federal Funding

Advanced Cell Technology, Inc. announced that human embryonic stem cell (hESC) line MA135 was unanimously approved for federal funding at the 100th Meeting of the Advisory Committee to the Director (ACD) National Institutes of Health (NIH). In addition to MA135, seven additional stem cell lines derived at ACT are currently under review by the NIH. Five of these lines were produced without embryo destruction using ACT's proprietary single-blastomere "embryo-safe" technology. The federal funding could accelerate the company's clinical activities.

There were previously only 67 hESC lines eligible for use in NIH-funded research. "We are extremely pleased with the NIH's decision to add this line to their registry," said Robert Lanza, M.D., Chief Scientific Officer of ACT. "This decision facilitates the use of embryonic stem cells as a potential source of replacement cells to treat a wide range of human diseases."

"This approval is a watershed moment for the company, because it provides the company with the opportunity to pursue non-dilutive federally funded research programs utilizing a stem cell line derived solely by technology that we deployed," said William M. Caldwell IV, Chairman and Chief Executive Officer of ACT. "We are optimistic that we will secure approval for additional lines using our single-cell blastomere technology in the coming months as the NIH finalizes their Proposed Rule Making expanding the definition of what will constitute a stem cell line that is eligible for federal funding. We applaud the NIH for its ongoing efforts to make more stem cell lines available to the scientific community." (Source: Advanced Cell Technology, Inc., 11 June, 2010)

Genzyme to Remain Under Federal Oversight for Seven to Eight Years

Genzyme Corp. will remain under federal oversight for the next seven to eight years as it works to fix quality-control problems that have bedeviled its Allston Landing plant for 15 months. The timetable was spelled out in a consent decree struck between Genzyme and the FDA. Under its terms, Genzyme will pay a previously disclosed $175 million federal fine, the first in its 29-year history. The agreement, filed with the US District Court in Boston, is subject to court approval.

Genzyme's plant in Allston produces drugs to treat rare genetic disorders such as Gaucher, Fabry, and Pompe diseases. The treatments can cost as much as $300,000 a year per patient.Last summer, the company had to suspend drug production after a virus was found at the plant. The temporary shutdown delayed shipments of enzyme replacement therapies Cerezyme (for Gaucher disease) and Fabrazyme (for Fabry disease), frustrating patients and depressing sales.

Although the company said earlier this year that it expected to pay the $175 million fine, other terms of the consent decree were not known until May. Among them, Genzyme agreed to move fill-finishing work for its domestic drug shipments out of the Allston site by November. The transfer of fill-finishing for overseas shipments will take place by Aug. 31, 2011. Late last year, inspectors found bits of steel, rubber, and fiber in some drugs during the fill-finishing process in Allston. The work will be moved to a Genzyme operation in Waterford, Ireland, and to subcontractors such as Hospira Inc., subject to approval by federal regulators. The firm faces additional fines if it fails to meet FDA deadlines.

In all, the Cambridge biotechnology giant will spend two to three years in remediation under the consent decree, and another five years under oversight by a third-party contractor, the Quantic Group, a Livingston, N.J., consulting firm focused on boosting manufacturing quality and safety. Quantic will craft a remediation plan with Genzyme, and the company could be fined $15,000 a day for missing milestones.

"This is in line with our expectations," Genzyme spokeswoman Lori Gorski said of the consent decree. "We're focused on restoring the confidence of the FDA. And we now have a framework to achieve our goal of returning to the highest manufacturing standards and restoring a reliable product supply for our patients." (Source:  Robert Weisman, Boston Globe, 25 May, 2010)

Genzyme's Lumizyme Wins FDA Approval

Genzyme Corp. recently received a significant boost by winning long-sought FDA approval for its enzyme replacement drug Lumizyme to treat Pompe disease patients in the US. The decision represents the most important US drug approval for the Cambridge biotech since 2003, when regulators signed off on Fabrazyme, a treatment for Fabry disease. Genzyme hopes Lumizyme will become a blockbuster, with worldwide sales of at least $1 billion annually.

"This will be our fastest-growing product," said John P. Butler, president of personalized genetic health at Genzyme. The company has spent more than 10 years and $1 billion developing Lumizyme, Butler added. "The United States is the single largest market for this product, and now we have complete access to that market," he said. No other company is marketing a drug for Pompe disease in the United States. The company plans to ship the drug from a plant in Geel, Belgium.

Most immediately, the FDA approval means Genzyme will be able to sell Lumizyme to about 200 adult patients in the US who have been receiving it for free under a charitable program. The company can also begin marketing the drug to about 1,000 adults who have Pompe disease but are not yet being treated. Genzyme executives said the drug's price would probably be in line with what it costs in the more than 40 countries in Europe and elsewhere where it is already approved: about $300,000 per patient annually. Most of the expense is paid by insurers or governments.

Pompe disease is a rare disorder that causes heart and skeletal muscle weakness that can progress to respiratory problems and eventually cause death from respiratory failure. The enzyme deficiency "is a devastating condition without the appropriate treatment," said Dr. Julie Beitz, a director at the FDA's Center for Drug Evaluation and Research in Silver Spring, Md. "The approval of Lumizyme will provide an important treatment for patients diagnosed late in life with Pompe disease." Genzyme currently produces another version of the Pompe disease drug, called Myozyme, in 160-liter batches at its plant in Framingham. But Myozyme has been reserved primarily for infants and children with more serious forms of the disease.

The company made Lumizyme at its Allston plant in Boston for about three years to supply US adults with Pompe under its charitable program. But production was suspended last spring after the FDA issued a warning about manufacturing shortcomings and Genzyme concluded the plant was overtaxed. (Genzyme still makes two other enzyme replacement drugs at Allston Landing: Cerezyme for Gaucher disease, its top-selling product, and Fabrazyme for Fabry disease.)

But in the past 15 months, it has struggled with a host of quality-control problems at the plant, including the discovery of a virus that caused a monthlong production halt last summer, leading to a consent agreement with the FDA. Since it stopped production in Allston, Genzyme has shipped the drug from Belgium for its charitable program.

FDA officials had approved Myozyme in smaller batches, but they required a separate approval process for Lumizyme because the agency concluded the two drugs have different carbohydrate structures. Initially, Genzyme applied to make the drug in Allston Landing. But after its manufacturing problems surfaced, it negotiated a different path to Lumizyme's approval with the FDA, including the plan to make the drug overseas. (Source: Robert Weisman, Boston Globe, 26 May 2010)

Shire Pays $200m for Lab Buildings

Drug maker Shire Pharmaceuticals is buying four buildings in Raytheon's former Lexington campus along Route 2 for more than $200 million, marking a major move forward for the recovering commercial real estate market. The transaction is the largest purchase of laboratory space in the region's growing life sciences sector, real estate officials said.

Shire and another biotech company are already tenants in the buildings, which made them an attractive investment to a slew of bidders. But the pharmaceutical giant won out in the end for the 435,000 square feet of laboratory space in the campus, which is known as Lexington Technology Park. The deal also includes an option for Shire to build on adjacent land that could host up to 370,000 square feet of space, according to people involved in the transaction who were not authorized to speak publicly.

The park is spread across 100 acres at the intersection of routes 2 and 128. Raytheon sold the site to Patriot Partners in 2002, and its buildings have since been renovated. In November 2009, the town of Lexington voted to support an additional 380,000 square feet of development within the park, helping to clear more room for biotechnology companies to expand there.

Shire began relocating operations from Cambridge several years ago and in 2008 launched a $460 million campaign to build a campus there and add 750 jobs. It held a ceremony to mark the completion of a 200,000-square-foot manufacturing facility on the property. The firm has also broken ground on another 150,000-square-foot facility expected to be completed in two years. (Source: Casey Ross, Boston Globe, 28 May, 2010)

Covidien Buys Device Maker for $2.6B

In its largest deal since it was spun out of the former Tyco International Inc. three years ago, Covidien PLC yesterday said it will buy vascular device maker ev3 Inc. for $2.6 billion in cash and debt, a 19 percent premium over ev3's closing stock price Friday. Covidien, the former Tyco HealthCare division, is incorporated in Ireland but has its corporate headquarters in Mansfield. It has acquired more than a dozen smaller companies in the past three years, as it worked to emerge from the Tyco shadow and build its own brand in the fields of medical devices, hospital supplies, and generic drugs.

"This gives us another avenue of growth," Covidien chief executive Richard J. Meelia said yesterday. "The majority of our growth has come from our surgical and pharmaceutical franchises. We've been very interested in building out the vascular market. It's going to be one of our biggest growth opportunities."

Vascular devices are used in surgeries and procedures involving veins, arteries, and nerves. The two market segments served by ev3 - peripheral vascular and neurovascular disease technologies - together ring up annual sales of about $3.5 billion, Meelia said. Ev3, based in Plymouth, MN, anticipated revenue of about $525 million this year, meaning Covidien will have room to expand sales of its new line of stents, catheters, angioplasty balloons, plaque excision systems, embolization coils, and other devices.

Until last year, Covidien was only a small player in the vascular space, marketing hospital supplies such as compression sleeves and anti-embolism stockings. Then it acquired VNUS Medical Technologies of San Jose, Calif., last May, paying $440 million to gain a minimally invasive treatment for venous reflux disease. At that time, Covidien set up a vascular device business unit within its medical device group. That was followed in June by Covidien's smaller acquisition for an undisclosed sum of Bacchus Vascular Inc., a Santa Clara, Calif., pioneer of interven tional therapies for deep vein thrombosis.

The devices sold by VNUS and Bacchus serve two of the fastest-growing niches in the vascular device business, markets expanding by estimated annual rates of 19 percent and 15 percent respectively, said Harry Glorikian, managing partner at Scientia Advisors, a Cambridge consulting firm that focuses on life sciences. Those products were "toes in the water," he said, positioning Covidien for a deeper dive with ev3, whose products compete with industry giants such as Natick's Boston Scientific and Medtronic of Minneapolis.

Covidien, which posted revenue of $10.7 billion last year, has about 42,000 employees worldwide, including 1,300 at its sites in Massachusetts, including Bedford and Chicopee in addition to Mansfield. Its largest business group is medical devices, which generated $6.1 billion in 2009 sales, or about 57 percent of the total. Within the Covidien medical device business, however, vascular devices accounted for less than 10 percent of revenues last year. (Source: Robert Weisman, Boston Globe, 2 June 2010)

Pfizer Set to Cut 300 jobs in Andover

Pharmaceutical giant Pfizer said it will eliminate about 300 manufacturing jobs at its Andover plant over the next five years as part of a global reduction in production capacity following its purchase of Wyeth Pharmaceuticals. The job cuts, which will be accomplished through layoffs and attrition, will leave Pfizer with just over 2,000 employees in Massachusetts, including 1,300 at the former Wyeth manufacturing plant and 750 at two research and development sites in Cambridge.

Wyeth had nearly 1,900 production and research workers at its Andover plant in the fall of 2007, two years before Pfizer completed its blockbuster $68 billion purchase of the drug maker. Since then, Pfizer has been working to scale back manufacturing capacity.

The new round of cuts in Andover is part of a broader move to reconfigure the Pfizer production network worldwide. As part of that effort, the company said it will shut down eight plants in the United States, Puerto Rico, and Ireland, while reducing operations at another six - including the Andover plant - in the United States, Puerto Rico, Germany, Ireland, and the UK. Those moves will pare 6,000 jobs in all. Despite the Andover rollback, Pfizer remains committed to Massachusetts, where it is developing and manufacturing drugs and collaborating with academic labs and smaller biotech partners, said Liz Power, spokeswoman for the New York-based drug maker.

Pfizer's Power said that, even with the staffing cutback, the company plans to continue its three existing production lines in Andover. Workers there make BeneFix, an injectable medicine that treats hemophilia B, a bleeding condition also known as Christmas disease; bone morphogenetic protein, which stimulates bone growth for people with spinal degeneration and is marketed by Pfizer partner Medtronic as part of a drug-device combination known as Infuse; and a component of the pneumonia vaccine Prevnar. Pfizer plans to consolidate global production of the Prevnar component - polysaccharides that target certain strains of pneumonia - in Andover as part of its overall consolidation, Power said. (Source: Robert Weisman, Boston Globe, 19 May 2010)

Pfizer to Pay Academics to Find Uses for Molecules

Pfizer Inc. said that it has agreed to pay $22.5 million over five years to researchers at the medical school of Washington University in St. Louis in a bid to breathe new life into existing compounds developed for other uses. The researchers will be able to check out about 500 Pfizer molecules targeting a range of diseases and study new uses for those molecules that the researchers believe are promising, said Jeff Gordon, director of the medical school's Center for Genome Sciences & Systems Biology.

The Pfizer molecules were approved for a different use, are in development for a separate indication or failed during clinical testing for another use, said Don Frail, chief scientific officer at Pfizer's Indications Discovery Unit. The unit was established in 2007 to enlist outsiders for help finding additional uses for compounds that Pfizer already had in various stages of development.

The project marks the latest effort by a big drug maker to share valuable intellectual property in a bid to replace aging pipelines. Companies have established joint ventures with rivals and signed agreements with scientists overseas, and rely heavily on outside companies called contract research organizations to share the risks and reduce the costs of developing new medicines.

Pfizer and Washington University's medical school said their collaboration is unusual in that industry and academia have teamed up in drug development. Drug makers have normally paid universities for basic research into diseases or enlisted their help during clinical testing of promising drugs. "What we are looking for is the intersection of their academic interest and disease knowledge with a mechanism we have a compound for," Mr. Frail said. Should a compound win approval for a use pursued by a university researcher, the medical school could get rights to the discovery and negotiate a licensing agreement, according to Dr. Gordon and Mr. Frail. (Source:  Jonathan D. Rockoff, Wall Street Journal, 18 May, 2010)

Huge Biotech Center Gets Green Light

Cambridge officials approved development of what would be the region's largest biotech complex, a 1.7 million-square-foot research center near Kendall Square. The $1 billion development, planned by Alexandria Real Estate Equities Inc., will include five new buildings as well as restoration of several historic buildings on 11 acres along Binney Street. The city's planning board signed off on the project.

"The Binney Street project is one of the most important developments of its kind and will further enhance Cambridge's position as a world-leading center for life-science research and development," said Tom Andrews, regional market director for Alexandria. Alexandria has not announced a starting date for construction and is still looking for a main tenant. The project is also slated to include two acres of public parks and a new transportation center for buses, bicycles, and vans. (Source:  Casey Ross, Boston Globe, 4 June, 2010)

Vertex Says Hepatitis Drug Meets Goal

Vertex Pharmaceuticals Inc. said its potential hepatitis C drug met a key goal of curing the hard-to-treat virus in a late-stage study. The company said 75 percent of patients receiving telaprevir for 12 weeks experienced a sustained response, or viral cure.

Hepatitis C is a virus that can cause severe liver damage. In the study, telaprevir was followed by a combination of pegylated interferon and Ribavirin, which is considered the standard of care. Patients on that telaprevir combination were compared with those receiving only pegylated interferon and Ribavirin. After 48 weeks, 44 percent in that arm of the study experienced a sustained response. The company expects to ask for FDA approval during the second half of 2010. (Source:  Associated Press, 26 May 26, 2010)

Abbott Labs to Become Number One Drugmaker in India

Abbott Laboratories has declared its intention to acquire Indian branded generics drugmaker Piramal Healthcare's Solutions business (Domestic Formulations), for an up-front payment of $2.12 billion, plus $400 million annually for the next four years (for a total of $3.72 billion), and will result in Abbott gaining number one position in the Indian pharmaceutical market.

There had been strong speculation that France's Sanofi-Aventis and US behemoth Pfizer were vying to buy Piramal. Abbott says that the transaction will not impact on its earnings outlook for 2010, and the company s plans to fund the deal with cash on its balance sheet. This deal is subject to shareholder approval of Piramal Healthcare and other customary closing conditions, and is expected to close in the second half of 2010.

The announcement is further evidence of the growing importance to multinational drug majors of generics and emerging markets, and further accelerates Abbott's growth in such sectors. The US company recently completed its buy of Belgian firm Solvay Pharmaceuticals for $6.6 billion and revealed a collaboration with India's Zydus Cadila, as well as the creation of a new stand-alone Established Products Division to focus on expanding the global markets for its leading branded generics portfolio.

"This strategic action will advance Abbott into the leading market position in India, one of the world's most attractive and rapidly growing markets," said Miles White, chairman and chief executive of Abbott. "Our strong position in branded generics and growing presence in emerging markets is part of our ongoing diversified pharmaceutical strategy, complementing our market-leading proprietary pharmaceutical offerings and pipeline in developed markets." He continued, "Emerging markets represent one of the greatest opportunities in health care - not only in pharmaceuticals - but across all of our business segments. Today, emerging markets represent more than 20 percent of Abbott's total business."

India is one of the world's fastest-growing pharmaceutical markets, due in large part to branded generics, noted Abbott in a statement. The market will generate nearly $8 billion in pharmaceutical annual sales this year, a number that is expected to more than double by 2015. Abbott estimates the growth of its Indian pharmaceutical business with Piramal to approach 20 percent annually, with expected sales of more than $2.5 billion by 2020.

Branded generics have significant brand equity in many international markets, providing durable, sustainable franchises for future growth. Piramal markets the products in its Healthcare Solutions business in India only and does not market traditional generic products. Today, says Abbott, branded generics account for 25 percent of the global pharmaceutical market, have the majority of market share in the largest emerging markets, and are expected to outpace growth of patented and generic products.

The Mumbai-based Piramal Healthcare Solutions business has a comprehensive portfolio of branded generics with annual sales expected to exceed $500 million next year in India, and market-leading brands in multiple therapeutic areas, including antibiotics, respiratory, cardiovascular, pain and neuroscience. This business grew 23 percent in the 2010 fiscal year, faster than the market in India. The business will become part of Abbott's newly-created, stand-alone Established Products Division. (Source:  thepharmaletter, 21 May, 2010)

Study Finds Bristol-Myers Squibb Melanoma Drug Improves Survival Rate

Researchers have scored the first big win against melanoma, the deadliest form of skin cancer. An experimental drug significantly improved survival in a major study of people with very advanced disease. The results, reported at a cancer conference, left doctors elated. "We have not had any therapy that has prolonged survival" until now, said Dr. Lynn Schuchter of the Abramson Cancer Center at the University of Pennsylvania, a skin cancer specialist.

The drug, ipilimumab, works by helping the immune system fight tumors. The FDA has pledged a quick review and doctors think the drug could be available by the end of this year.

Melanoma is the most serious form of skin cancer. Last year in the US, there were about 68,720 new cases and 8,650 deaths from the disease. Worldwide, more than 50,000 people die of melanoma each year. "The incidence is rising faster than any other cancer," said one of the study's leaders, Dr. Stephen Hodi of Dana-Farber Cancer Institute in Boston. "When it spreads to vital organs, it's almost always fatal."

The skin cancer study involved 676 people around the world with advanced, inoperable melanoma who had already tried other treatments - a very grim situation. They were given one of three treatments: ipilimumab by itself, with another immune-stimulating treatment, or the immune-stimulating treatment alone. After two years, 24 percent of those given the drug alone or in combination were alive, versus 14 percent of those given just the immune-stimulating treatment.

Average survival was 10 months with ipilimumab versus just more than six months for the others, which worked out to a 67 percent improvement in survival for those on the drug, said one of the study's leaders, Dr. Steven O'Day of the Angeles Clinic and Research Institute in Los Angeles. Doctors hope the drug can provide more benefit if given earlier in the course of the disease and to less sick patients. Ten percent to 15 percent of patients on ipilimumab had serious side effects related to the drug's actions on the immune system. Most were treatable with high doses of steroids, but 14 deaths were thought to be related to the treatment. That's still far fewer than deaths due to the cancer.

The study was funded by Bristol-Myers and Medarex Inc., a company that co-developed the drug and was bought by Bristol-Myers last year. A spokeswoman said Bristol-Myers has not yet set a price for the drug, but similar treatments for other cancers cost several thousand dollars a month or more. Results were reported at the American Society of Clinical Oncology's annual conference in Chicago and published online by the New England Journal of Medicine. (Source:  Marilynn Marchione, Associated Press, 5 June 2010)