(VPHM) Update on ViroPharma Industrial Facility

ViroPharma Inc. (VPHM) recently announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Cinryze’s industrial scale manufacturing facility.

The regulatory body made three comments related to a portion of the cleaning validation for industrial scale manufacturing, of which only one requires additional unplanned activity. ViroPharma does not expect this activity to take much time to complete.

The FDA also said that it has not finished reviewing the company’s January 2012 updated responses to observations specific to the September 2011 inspection of the Amsterdam facility.

We note that ViroPharma undertook an expansion of the production capacity for Cinryze in 2009. In early 2010, the company submitted the Cinryze industrial scale manufacturing Prior Approval Supplement (PAS) to the FDA. In October 2010, the regulatory body issued a CRL, asking for additional information on observations from the pre-approval inspection and review of the technical processes. In October 2011, ViroPharma submitted its response to the CRL.

The company expects the regulatory approval of the facility to increase its supply by 100,000 – 120,000 doses, for up to 160,000 doses annually, or $640 million worth of product. We believe that successfully building an industrial-scale facility is an important catalyst for ViroPharma shares, as future growth of Cinryze sales rely on added production capacity.

Cinryze is one of the leading products at ViroPharma. The company markets the drug worldwide in the intravenous form as a treatment for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE).

Further, ViroPharma recently reported positive top-line data from a mid-stage trial on the subcutaneous (SC) formulation of Cinryze. The company is studying the drug as a SC formulation in partnership with Halozyme Therapeutics Inc. (HALO).

We currently have an Outperform recommendation on ViroPharma. The stock carries a Zacks #1 Rank (Strong Buy rating) in the short-run.

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