Zacks_Analysts' Blog : EU Clears ViroPharma's Drug - Analyst Blog

ViroPharma Inc. (VPHM) recently received approval from the European Commission (EC) for its epilepsy drug, Buccolam. The European regulatory body granted a Centralized Pediatric Use Marketing Authorization (PUMA) for Buccolam for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, aged 3 months to 18 years.

PUMA is a new type of centralized marketing authorization procedure for medicines that are already authorized but are no longer covered by intellectual property rights and are exclusively developed for use in children.

The European approval of Buccolam triggered a payment of £10 million ($16.3 million), which ViroPharma will make to Auralis Limited, the former owners of the candidate. ViroPharma acquired Buccolam from Auralis in May 2010.

The EC’s approval of Buccolam does not come as a surprise, as in June, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended the same.

The EC’s approval of Buccolam for convulsive seizures is an important milestone for ViroPharma after the regulatory body granted Centralized Marketing Authorization to Cinryze for the treatment of hereditary angioedema (HAE) in mid-June 2011.

Cinryze is indicated for the treatment of pre-procedure prevention of angioedema attacks in adults and adolescents with HAE, and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of HAE, who are intolerant of or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.

We note that in May, ViroPharma had entered into a global licensing deal with Halozyme Therapeutics, Inc. (HALO), for using the latter’s rHuPH20 (recombinant human hyaluronidase) for the development of a subcutaneous formulation of Cinryze, which is expected to enter phase II studies by the end of 2011.

The agreement requires ViroPharma to fund all the development and commercialization expenses related to the program.

We currently have a Neutral recommendation on ViroPharma. The stock carries a Zacks #3 Rank (Hold rating) in the short run.