UPDATE 1-FDA denies ViroPharma's higher genetic-drug production
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ViroPharma Incorporated
VPHM.O
$15.20
-0.99-6.11%7:25pm UTC+0300
Fri Oct 22, 2010 9:25am EDT
* Co says FDA seeks more information
* Co says to go ahead with manufacturing at risk
* Says approved process to yield 60,000 doses annually
* Shares fall as much as 17 pct before the bell
Oct 22 (Reuters) - ViroPharma Inc (VPHM.O), a specialty pharmaceutical company, said U.S. health regulators declined to approve industrial-scale manufacturing of its genetic disorder drug Cinryze, sending its shares down 17 percent.
In a complete response letter to ViroPharma, the U.S. Food and Drug Administration (FDA) sought additional information related to observations from the pre-approval inspection and review of the technical processes, the company said.
ViroPharma said it will respond to the FDA and plans to start manufacturing industrial scale lots at risk in the first quarter of 2011.
The company however, expects its currently approved manufacturing process alone to yield up to 60,000 doses annually.
Cinryze is the company's approved treatment for a fatal genetic disorder called hereditary angioedema and is expected to generate full-year revenue of $165-$175 million.
In June, ViroPharma approached the FDA, seeking approval to commercialize Cinryze manufactured using the industrial scale process. [ID:nWNAB9826]
The company's shares, which had plunged 18 percent since it expressed doubts over the drug's production capability in October last year, fell to $13.51 pre-market trade on Friday. They closed at $16.19 Thursday on Nasdaq. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Gopakumar Warrier)
