May 31, 2007 Notes: Acambis's Smallpox Vaccine Approved by FDA, Microbix Discovers Vaccine Production-Boosting Manufacturing Process, more

May 31, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Acambis, FDA, Biogen, Ranbaxy, more

Company Notes

Cambridge, UK (May 17)-Acambis plc's (www.acambis.com) smallpox vaccine, ACAM2000, received positive recommendations from the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration (Rockville, MD, www.fda.gov). The recommendation clears the way for Acambis to form a warm-base manufacturing contract with the Center for Disease Control and Prevention (CDC, Atlanta, GA, www.cdc.gov). Under the contract, Acambis would provide smallpox vaccine production in the United States.

Thousand Oaks, CA (May 25)-Amgen's (www.amgen.com) marketing authorization application for its colorectal cancer treatment "Vectibix" received a negative opinion from the European Committee for Medicinal Products for Human Use (CHMP, London, www.emea.europa.eu). Amgen will appeal the CHMP's opinion.

Cambridge, MA (May 29)-The board of directors of Biogen Idec (www.biogenidec.com) authorized a $3-billion share repurchase through a modified Dutch Auction tender offer of 16% of the company's outstanding common stock. The company hopes the buyback will allow it to invest in its drug pipeline. The repurchase will be funded through a combination of up to $2.5 billion in cash and up to $1.5 billion of debt.

Princeton, NJ and Osaka, Japan (May 30)-BioWa, Inc. (www.biowa.com) entered into an agreement with Takeda Pharmaceutical Company Limited (www.takeda.com). The agreement gives Takeda access to BioWa's "Potelligent" antibody-development platform. Takeda will have nonexclusive rights to research, develop, manufacture, and commercialize antibodies based on the Potelligent platform. BioWa will receive upfront and milestone payments, license fees, and royalties on products developed using the Potelligent platform.

Mississauga, ON, Canada (May 23)-Draxis Health Inc.'s (www.draxis.com) manufacturing operations in Montreal, Quebec, passed their recent US Food and Drug Administration (Rockville, MD, www.fda.gov) inspections. The inspections largely focused on two additional products manufactured on behalf of clients at Draxis's lyophilization production facility.

Liverpool, UK (May 21)-The UK Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk) awarded Eden Biodesign Ltd. (www.edenbiodesign.com) a license to manufacture investigational medicinal products at the Eden-operated National Biomanufacturing Center in Liverpool. Eden now has the authority to manufacture biopharmaceutical drug substances for clients to use in EU clinical trials.

Toronto, ON, Canada (May 30)-Microbix Biosystems Inc. (www.microbix.com) discovered a process that could boost influenza-vaccine production. The process increases the virus yield from eggs by retrieving virus from debris in the egg that usually is discarded. Independent testing at the Queen Elizabeth II Health Sciences Center in Halifax, Nova Scotia confirmed that this process doubles the amount of virus recovered.

San Carlos, CA (May 24)-Nektar Therapeutics (www.nektar.com) announced a restructuring plan aimed at reducing its ongoing spending. The company will cut 25% of its staff and reduce its spending by approximately $65 million. Nektar hopes the restructuring will allow it to accelerate the development of its pipeline.

Oss, Netherlands (May 23)-N.V. Organon (www.organon.com) and Royal Philips Electronics (Amsterdam, Netherlands, www.philips.com) will collaborate to develop new drugs and therapies for mental disorders and cancer. Organon and Philips will use biomarkers and Philips's noninvasive medical-imaging technology to study the effects of psychiatric drugs in the brain at the molecular level. The companies hope that their collaboration will help speed up the development and approval of new drugs. They also hope to monitor the effects of certain therapies in order to customize treatment programs.

Gurgaon, India (May 29)-A Norwegian appeals court sided with Ranbaxy Laboratories Limited (www.ranbaxy.com) in a patent dispute with Pfizer (New York, www.pfizer.com). The four patents in dispute relate to atorvastatin, the key ingredient in Pfizer's blockbuster cholesterol drug "Lipitor." Norwegian courts found that Ranbaxy had not infringed on two of Pfizer's Norwegian patents covering intermediate compounds. The appeals court ruled that Pfizer's Norwegian process patent relating to the process for manufacturing amorphous atorvastatin was invalid. The ruling paves the way for Ranbaxy to market generic atorvastatin tablets in Norway. Pfizer is appealing the case to Norway's supreme court.

Princeton, NJ (May 28)-Ranbaxy Laboratories Inc. (www.ranbaxyusa.com), a subsidiary of Ranbaxy Laboratories Limited (Gurgaon, India, www.ranbaxy.com) acquired the US rights to 13 dermatology products from Bristol-Myers Squibb Company (Princeton, NJ, www.bms.com). The brands will be sold in the United States under the Ranbaxy Laboratories Inc. label.

London (May 22)-The Medicines and Healthcare products Regulatory Agency (MHRA, www.mhra.gov.uk) announced that counterfeit batches of "Plavix," a blood-thinning drug manufactured by Sanofi-Aventis (Paris, http://en.sanofi-aventis.com) have been found in the British supply chain. MHRA issued a recall of the affected consignments of Plavix, which were supplied by parallel distributors.

Mumbai, India (May 25)-Strides Arcolab's (www.stridesarco.com) sterile manufacturing site in Bangalore received approval from the US Food and Drug Administration (Rockville, MD, www.fda.gov). The facility manufactures injectables in freeze-dried and liquid vials, prefilled syringes, and dry-powder sterile forms of nonpenicillin and noncephalosporin therapeutic formats.

Nantes, France (May 30)-Vivalis (www.vivalis.com) granted license agreements for its EBx cell lines to several pharmaceutical companies. Nobilon (Boxmeer, Netherlands, www.nobilon.com), CSL Limited (Parkville, Victoria, Australia, www.csl.com.au), and GlaxoSmithKline (London, www.gsk.com) all have been granted the right to use EBx cell lines to produce seasonal and pandemic influenza vaccines.

Mississauga, ON, Canada (May 24)-YM BioSciences Inc.'s (www.ymbiosciences.com) manufacturing facility for nimotuzumab was successfully scaled up to a 500-L-capacity continuous-perfusion fermentation process. Also, Health Canada and a regulatory authority in the European Union inspected and certified the manufacturing process for nimotuzumab and the newly enlarged facility. Nimotuzumab is a humanized monoclonal antibody for the treatment of cancer.

 

People Notes

Mississauga, ON, Canada( May 29)-Draxis Pharma (www.draxis.com) named Bruce DeChambre vice-president of commercial and business development. DeChambre previoiusly was vice-president of sales and marketing at SAB-Pharma. He also held positions at Abraxis Pharmaceutical, Fujisawa USA, Inc., and Baxter Healthcare Corp.

Indianapolis, IN (May 25)-Eli Lilly and Co. (www.lilly.com) promoted Frank Deane to president of manufacturing. Deane is currently vice-president, quality. He joined Lilly in 1979 at the company's manufacturing operations in Kinsale, Ireland.

Irvine, CA (May 29)-Timothy P. Walbert was named chief executive officer of IDM Pharma (www.idm-pharma.com). Walbert previously was executive vice-president, commercial operations with NeoPharm, Inc.

Burlington, MA (May 24)-Robert M. Haggerty was appointed vice-president of quality with Hyaluron Contract Manufacturing (www.hyaluron.com). Haggerty served as director of quality assurance at Alexion Pharmaceuticals and held varous positions at Ben Venue, Dupont, and Transkaryotic Therapies.

Winnipeg, Manitoba, Canada (May 23)-Gord Froehlich, president of Kane Biotech Inc. (www.kanebiotech.com) will assume the additional title of chief executive officer.