FDA cites nearly 50 areas of concern at Merck vaccine plant
MONTGOMERY COUNTY, Pa. According to a report in The Philadelphia Inquirer, the Food and Drug Administration have documented unwanted “fibers” in the stoppers of vaccine vials at Merck’s vaccine plant. The agency also found instances of contaminated children’s vaccines and complaints that weren’t always investigated.
Inspectors from the FDA spent 30 days at the plant between November and January of this year and cited 49 areas of concern, including a failure to follow good management practices.
John McCubbins, Merck’s head of global vaccine manufacturing and West Point operations, disputed that assessment. He maintained that the division’s employment had kept pace with vaccine production. He stressed that no contamination was found in finished vaccines and that Merck was addressing all the problems.
McCubbins stressed that Merck’s own technicians—not FDA inspectors—had detected and reported most of the problems, which were found in the manufacturing process, not in vaccines themselves.
The report cites cases where bulk lots of Pedvax and ProQuad were contaminated. Unwanted “fibers” were found on the vial stoppers of MMR, the measles mumps and rubella vaccine, among others. They were caused by “lesser quality” supplies from a vendor, the FDA report said.
The plant continues to operate, and the FDA has not ordered Merck to stop production or to recall any products.
Schering-Plough posts quarterly loss from purchase of Organon
KENILWORTH, N.J. Schering-Plough today released its first-quarter results for 2008, according to published reports. The drugmaker reported a net income of $253 million, down from $543 million during the first quarter of 2007, mostly due to the acquisition of the biotech company Organon BioSciences.
Sales though rose by 56 percent to $4.66 billion. Its rheumatoid arthritis drug Remicade’s sales rose by 36 percent to $507 million.
Vytorin and another cholesterol treatment drug Zetia, which Schering markets through a joint venture with Merck saw sales of both drugs combined rise 6 percent to $1.2 billion during the quarter. But they fell 5 percent in the United States amid the widely publicized failure of Vytorin to cut plaque in neck arteries in a study for which results were presented in January.
Merck said Monday it expects its revenue from the drugs to drop by $700 million over the rest of 2008.
Chief executive officer Fred Hassan said the company is on track with its plan to cut annual costs by $1.5 billion by 2012, announced earlier this month. About 10 percent of its 55,000 jobs are to be cut.
Genzyme plans expansion in China
CAMBRIDGE, Mass. Genzyme has announced that it will build a research and development center in Beijing as part of its global expansion, according to published reports.
The company expects the facility to open in 2010 and cost them about $90 million. It will be a 200,000 square-foot facility, which will be able to accommodate 350 employees.
Genzyme said it already has 25 employees working in offices in Beijing and Shanghai and has a pilot program for its cell therapy MACI at Beijing Wujing Hospital.