ViroPharma Inc. recently announced the launch of its epilepsy drug, Buccolam, in the United Kingdom (UK). The drug is approved for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, aged 3 months to 18 years.
We note that the European Commission granted Buccolam a Centralized Pediatric Use Marketing Authorization (PUMA) for the said indication in September 2011. 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. Also, the PUMA-authorized drugs are exclusively developed for children.
Buccolam became a part of ViroPharma’s portfolio following the acquisition of Auralis Limited in May 2010.
The UK launch of Buccolam for convulsive seizures is an important milestone for ViroPharma after the European approval of Buccolam and the approval of 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 2011, ViroPharma entered into a global licensing deal with Halozyme Therapeutics, Inc. (HALO - Snapshot Report), for using the latter’s rHuPH20 (recombinant human hyaluronidase) for the development of a subcutaneous formulation of Cinryze, which is currently in phase II. 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.