GMP issues affect Mircera, Xenical production at Roche plant
pharmafile | January 31, 2012 | News story | Manufacturing and Production |Â Â GMP, Mircera, Roche, Tamiflu, XenicalÂ
Supply of two Roche products has been disrupted after an active pharmaceutical ingredient (API) production facility in the US was discovered to be out of compliance with Good Manufacturing Practice (GMP).
Roche said it has stopped releasing batches of weight-loss treatment Xenical (orlistat) and red blood cell stimulator Mircera (methoxy polyethylene glycol-epoetin beta) made at the 300,000 sq. ft. plant in Florence, South Carolina, because of the GMP deficiencies, and shortages may result in some markets.
Other drugs made at the plant, including flu treatment Tamiflu (oseltamivir), Xeloda (capecitabine) for various cancers, antiviral drug Valcyte (valganciclovir HCl) and Pegasys (peginterferon alfa-2a) for hepatitis will still be released from the facility, according to a Wall Street Journal report. The nature of the GMP violations has not yet been revealed.
Roche has not broken out Xenical sales in recent quarterly financial reports, but said in 2010 that the drug achieved revenues of 377 million Swiss francs (about $415 million). Sales of the product have likely been affected by the availability of an over-the-counter version called Alli, which until recently was sold by GlaxoSmithKline in the US, as well as reports linking its use with liver complications in some patients.
Meanwhile, Mircera pulled in 237 million francs in the first nine months of 2011, a 45% increase over the same period of 2010.
The Florence facility was earmarked for closure by Roche last year, but the drugmaker granted its 300-plus staff a reprieve after receiving representations from state authorities.
At the time the plant looked set to be retained until at least 2014, when the patent on Xeloda expires. Workers will be hoping that the GMP issues do not have an impact on that holding position.
Phil Taylor
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