Setback for Hereditary Angioedema (VPHM)

Posted in General 
June 4th, 2009

ViroPharma (VPHM) has traded over 250,000 shares in the first 20 minutes since the halt was released.  The company has received a Complete Response letter from the FDA related to its supplemental Biologics License Application for Cinryze as a treatment for acute attacks of hereditary angioedema.

The FDA has requested an additional clinical study.  This is due to the FDA opinion that the placebo controlled study group data submitted in support of the sBLA “lacked robustness.”

Things could have been worse as as the FDA cited no safety concerns related to acute treatment with Cinryze in the clinical studies; and the FDA has already approved the patient labeling for Cinryze to include self-administration for routine prophylaxis, once patients are properly trained by their healthcare provider.   Viropharma plans to respond to the FDA about our plans, and it will provide an update on the second quarter financial call.

Shares are down almost 8% at $6.40 as of 8:24 AM EST; its 52-week trading range is $3.79 to $15.16.

Jon C. Ogg
June 4, 2009

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