Pfizer will discontinue development of drugs for heart disease, obesity and bone health as part of its plan to focus research on Alzheimer's disease, diabetes, inflammation/immunology, oncology, pain and psychoses (schizophrenia), according to a company memo. The shift in R&D focus was led by president Martin Mackay, a Pfizer research executive who took over the division in October of last year.
   
"It's a continuous process to constantly evaluate our pipeline and make decisions based on high priority, unmet medical needs with market growth potential," said Pfizer spokesman, Ray Kerins. The plan is expected to include job and cost cuts, but will not affect products in late stage development or launches scheduled during the next three years, according to Mr. Kerins.
   
Sales of Pfizer's Lipitor, the world's top selling drug, are slowing as patients have access to generic forms of Merck's Zocor and Lipitor faces generic competition in 2011. Also, the company's second top seller Norvasc lost patent protection in 2007. In December 2006, the company discontinued development of cholesterol-lowering drug Torcetrapib after it was linked to deaths in a large trial, costing the company $800 million.

MedImmune has licensed its reverse genetics technology to Biken, The Research Foundation for Microbial Diseases of Osaka University in Japan, for the development of new vaccine strains to produce non-live human influenza vaccines. Reverse genetics is a method that uses segments of DNA to generate viruses such as influenza. This method helps protect manufacturers from exposure to potentially highly infectious pandemic strains, such as H5N1.
   
MedImmune will receive an upfront payment and has the potential to receive royalties on certain vaccine stockpiles or sales of other flu products developed using the technology.
   
"MedImmune is pleased to license our reverse genetics technology to BIKEN as we have previously to four other influenza vaccine manufacturers," said Sun Park, MedImmune's vice president, corporate development. "Biken is the first Japanese influenza vaccine manufacturer to have entered into licensing agreements with MedImmune for access to the reverse genetics technology, and we are pleased that Biken's pre-pandemic vaccine using this technology is a key part of an ongoing Japanese government public health pilot program to vaccinate about 6,000 first responders and healthcare providers against a potential bird flu outbreak."
   
MedImmune applied the reverse genetics process to the development of its seasonal live, attenuated nasal spray flu vaccine for the 2008-2009 season.

Enzon Pharmaceuticals, Inc. received approval from the Commission of the European Communities for designation of Oncaspar-IV, the next-gen pegylated L-asparaginase, as an orphan medicinal product.
   
Orphan drug designation creates favorable conditions for the development of drugs, including potential financial incentives, in addition to market exclusivity for as many as 10 years following approval.
   
“This announcement is a significant milestone in our overall plan to market the new Oncaspar-IV in new geographic territories.” said Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. “We are currently developing the next-generation Oncaspar product to enhance the pharmaceutical properties of the approved version currently marketed in the U.S.”

Analytical Bio-Chemistry Labs (ABC Labs) opened its new 90,000- sq.-ft. pharmaceutical development facility located at the University of Missouri’s Discovery Ridge Research Park, completing the transition of the company’s DMPK, bioanalytical and CGMP Analytical operations to the new facility. The facility more than doubles the company's previous capacity.
   
“The qualification of the new pharmaceutical facility is complete. All laboratory systems are validated, and scientific teams are quickly settling into their new home," said John Bucksath, senior vice president and general manager of ABC’s Pharmaceutical Division. “We are wrapping up a carefully choreographed project plan—and I’m delighted to report that the transition of pharmaceutical operations went very smoothly." In July, the FDA completed a pre-approval and General Quality Systems audit of the facility, which resulted in no 483s.
   
"This is an exciting time in ABC's history," says Byron E. Hill, president and chief executive officer. "This expansion provides the ideal platform for a new era of growth, productivity and exceptional client service."

The company will continue operating its chemical services and synthesis operations at its original campus located about five miles east of Columbia. The expansion at Discovery Ridge frees up space for these areas of the business as well. The company plans to renovate existing structures in 2009 to optimize operational efficiency.

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