The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently gave the go ahead to ViroPharma Inc.’s (VPHM) Buccolam (midazolam, oromucosal solution). The company is seeking approval for Buccolam to be used as a treatment for prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years.
The European Commission’s (EC) decision on ViroPharma’s Pediatric Use Marketing Authorization (PUMA) for Buccolam is expected by the fourth quarter of 2011, which will also make the candidate the first product to gain approval under the centralized PUMA procedure.
PUMA is a new type of centralized marketing authorization procedure for medicines that are developed specifically for children and may already be approved for other indications or routes of administration in adults.
ViroPharma’s Recent Trajectory
The CHMP’s positive opinion comes as another important win for ViroPharma after the EC granted Centralized Marketing Authorization to Cinryze for the treatment of hereditary angioedema (HAE) in mid-June.
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 to 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.
Additionally, ViroPharma is studying Cinryze as a treatment for acute antibody-mediated rejection (AMR) in recipients of donor-specific cross-match positive kidney transplants. The company had commenced a phase II trial for the said indication in March.
We currently have a Neutral recommendation on ViroPharma, which carries a Zacks #3 Rank (short-term Hold rating).
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