FDA rejects Viropharma’s Cinryze manufacturing expansion
pharmafile | October 25, 2010 | News story | Sales and Marketing |Â Â Cinryze, FDA, FDA complete response letter, Viropharma, angioedema, pharmaceutical manufacturingÂ
ViroPharma was dealt a blow late last week when the FDA turned down its application for additional manufacturing capacity for Cinryze, its drug for hereditary angioedema.
Viropharma applied to the FDA to upgrade its production of Cinryze (C1 esterase inhibitor [human]), in order to meet rising demand for the product, which was approved in October 2008. The filing sought approval to double up the scale of its parallel chromatography production process for the drug.
The company had been hoping for a green light from the FDA before the end of this year. Instead, based on its pre-approval inspection the agency asked for more details, delaying the approval and prompting a 5% decline in Viropharma’s share price on Friday.
The FDA raised a “handful” of questions in its complete response letter for the application, said Viropharma chief executive Vincent Milano in a conference call. They related to some quality observations during the pre-approval inspection, as well as details on certain technical aspects of the production process, particularly related to documentation.
“We believe that the questions raised … are answerable in a timely manner,” said Milano. Critically, the FDA has not asked the company to make additional lots of Cinryze to check conformity with its earlier process, he added.
He also noted that the FDA’s decision would have no bearing on approval of Cinryze in Europe, which is still pending.
At the moment, Viropharma’s capacity for Cinryze is around 60,000 doses a year, and the new facility was intended to almost triple that to 160,000 doses, he said. Viropharma plans to commence manufacturing industrial scale lots “at risk” in the first quarter of 2011.
The company said that it and partner Sanquin Blood Supply Foundation will begin working to respond to the FDA “as expeditiously as possible”.
Milano said: “We remain committed to provide patients with an uninterrupted supply of Cinryze.” When production starts, inventory from the industrial-scale process could be produced within four to five months.
Ahead of the FDA’s decision, analysts at Leerink Swann had said that with the new capacity online Cinryze could grow to achieve peak sales of around $500 million by 2020. The drug achieved sales of around $75 million in the first half of 2010, accounting for around 38% of Viropharma’s total revenue.
Phil Taylor
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