Biogen API plant gets nicked by the FDA

Biogen Idec ($BIIB) has encountered its share of manufacturing headaches because of the multiple sclerosis drug Tysabri that it acquired from Elan ($ELN). It will now have to add to that list some limited FDA concerns over its API manufacturing.

According to a Form 483 posted Friday to the FDA website, inspectors during a 5-day visit in July noted a couple of problems with processes at the plant in North Carolina where Biogen makes the active pharmaceutical ingredients for both Tysabri and Avonex. Among other shortcomings, the FDA said Biogen Idec is too trusting with its supplier of the bulk bags used in the API closure system for Tysabri. The supplier certifies the bags are sterile and endotoxin free, but the FDA says Biogen has never once challenged or verified those results. Inspectors also noted Biogen was not logging information on some of the agents used in cleaning biosafety hoods in the Avonex production building or on surfaces in the Tysabri production building.  

Biogen Idec spokesman Steven Goldsmith said in an email Monday that the Form 483 came out of the routine biennial inspection the plant went through. While there were the two observations, he said the "inspectors conveyed an overall positive impression of the quality systems and processes at this site." He said Biogen welcomes the feedback and has responded "with robust corrective actions which are currently in progress." The campus, which employs more than 1,100, not only makes the APIs for Tysabri and Avonex but also a number of products in clinical trials.

Tysabri, while effective, has had a troubled history. Initially approved in 2004, the injectable MS drug was pulled from the market the next year after a number of patients died from an unusual brain infection, progressive multifocal leukoencephalopathy, or PML. But because the drug had worked so well, the FDA permitted Tysabri to return to the market in 2006 under a strict risk-management program. Biogen was satisfied enough with the drug that in February it agreed to pay its developer Elan $3.25 billion to get full control of it.

The market interruption in 2005, however, led Biogen to unload a plant in California where it had planned to expand production of the drug, which analysts had pegged as a potentially big seller. According to a news report at the time, Biogen was close to finishing the plant in Oceanside, CA, when the FDA had Tysabri withdrawn. The drugmaker decided the $80 million to $90 million it would cost to keep the plant open was too steep for a drug whose future was uncertain. It agreed to sell the 500,000-square-foot facility with its 90,000 liter bioreactor capacity to Genentech, now a subsidiary of Roche ($RHHBY). Genentech wanted to manufacture its cancer drug Avastin. A year after selling the plant, Tysabri returned to the market. 

- here's the Form 483 (PDF)