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Pharma/Fine Chemicals Roundup – June 19
June 19, 2012 | By DEEPTI RAMESH
FDA ISSUES CLOSE OUT LETTER TO AKZONOBEL’S API PLANT IN MEXICO
The U.S. Food and Drug Administration (FDA) issued a close-out letter on June 11, to Akzo Nobel Chemicals’ (Los Reyes La Paz, Mexico) active pharmaceutical ingredient (API) manufacturing plant at Los Reyes La Paz, which ends the warning and ‘import alert’ issued on the plant. The FDA had issued a warning letter and import alert in November 2011 to the Los Reyes La Paz plant, for deviating from current good manufacturing practice (cGMP). The FDA “has completed an evaluation of your firm's corrective actions in response to our warning letter,” says Cesar E. Matto, compliance officer at FDA in the close-out letter. “Based on our evaluation, it appears that you have addressed the violation(s) contained in the warning letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.”
PFIZER TO SPIN OFF ANIMAL HEALTH BUSINESS
Pfizer says that it will spin off its animal health business and the new standalone company will be called Zoetis. Preparations are underway to file a registration statement in the U.S. for a potential initial public offering (IPO) of a minority ownership stake in the new company, Pfizer says. “We are on track to create a standalone animal health company by our previously stated target of July 2013,” says Ian Read, chairman and CEO of Pfizer. The animal health business of Pfizer recorded revenues of about $4.2 billion in 2011.
Zoetis will build on the Pfizer animal health business in the discovery, development, manufacture and marketing of a portfolio of animal vaccines, medicines, biopharmaceuticals, diagnostics and genetic tests to prevent and treat disease in livestock and companion animals. The business has over 9,000 employees, and has an extensive research and development network and holds leading market positions across major geographic regions, including North America, Europe, Africa, the Mideast, Latin America, and Asia/Pacific, Pfizer says.
SIEGFRIED APPOINTS NEW HEAD OF R&D
Siegfried (Zofingen, Switzerland), a producer of active pharmaceutical ingredients (APIs), intermediates, and finished drugs, says it has appointed René Imwinkelried, as the company’s new head of research & development and member of the executive committee, effective September 1, 2012. He will succeed Wolfgang Wienand, who will now focus on further developing strategy and mergers & acquisitions in the executive committee and on legal and IP management. René Imwinkelried is currently head of technical development small molecules at Roche at Basel, Switzerland. Prior to his current position at Roche, René Imwinkelried executed various R&D functions at Lonza between 1991 and 2004 and held the position of head of global chemical and physical sciences at Schering-Plough from 2004 to 2010.
LONZA AND BIOWA SIGN LICENSE AGREEMENTS WITH FIVEPRIME THERAPEUTICS
Lonza says that biotechnology company Five Prime Therapeutics (South San Francisco, CA) has entered into research and commercial agreements with biotech firm BioWa (Princeton, NJ), a subsidiary of Kyowa Hakko Kirin (Tokyo), and Lonza, to use their Potelligent CHOK1SV cell line for the research, development and production of multiple proprietary antibodies in FivePrime’s oncology pipeline. Potelligent CHOK1SV is a host cell line for manufacturing recombinant antibodies that combines BioWa’s engineered glycosylation Potelligent technology with Lonza’s proprietary GS Gene Expression System, which includes the CHOK1SV cell line.
CODEXIS' INTERIM CFO RESIGNS
Codexis announced that its interim CFO Brian Dowd has resigned to accept another position at a private company. The company recently named John Nicols president and CEO after the resignation of 10-year CEO Alan Shaw in February.
Shaw was with the company since its founding, and his departure came shortly after that of CFO Bob Lawson’s resignation. The company has been pressured from poor stock performance and its shares have fallen 70% from its IPO price. Shell contributes significant funding to Codexis as a part of their collaboration and licensing agreement, however there have been delays in their cellulosic biofuel project, causing speculation and shake-ups in management positions.
DSM CLOSES TENDER OFFER FOR BIOMEDICAL FIRM KENSEY NASH
DSM says that the previously announced tender offer to acquire all the outstanding shares of common stock of biomedical company Kensey Nash (Exton, PA) was successful. DSM had announced last month that it would acquire Kensey Nash through a cash tender offer for about $360 million. The tender offer expired on June 18, and the acquisition is expected to close within a few days, DSM says. Kensey Nash is primarily focused on regenerative medicine utilizing its proprietary collagen and synthetic polymer technology. It manufactures and sells medical device parts in cardiology, orthopedic, sports medicine, spinal and general surgery. The company employs about 325 people.
OVER $290 BILLION OF SALES AT RISK FROM PATENT EXPIRATIONS FROM 2012-2018
The patent cliff will reshape the drug industry over the next six years and more than $290 billion of sales is at risk from patent expirations from 2012 to 2018, says a new report by EvaluatePharma (London). The global prescription drug sales market will have a CAGR of about 3.1% from 2011 to 2018, and worldwide prescription drug sales is forecast to total $885 billion in 2018, the report says. However, prescription drug sales are forecast to decline by 0.9% in 2012 due to a large number of patent expiries and a decline in the value of euro. Pfizer remains the largest pharmaceutical company by sales in 2011, but Novartis is expected to become the leading company in 2018, the report says. Merck & Co.’s (Whitehouse Station, NJ) Januvia/Janumet for the treatment of type 2 diabetes is expected to be the world’s largest selling drug in 2018.