ViroPharma Inc. (VPHM) recently announced that the European Commission (EC) granted Centralized Marketing Authorization to Cinryze for the treatment of hereditary angioedema (HAE).
The drug 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.
The EC’s approval of Cinryze does not come as a surprise, as in March the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended it.
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.
Under the collaboration, the companies will initially focus on the development of a subcutaneous formulation of Cinryze for routine prophylaxis, against HAE attacks.
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 commenced a phase II trial for the said indication in March.
Our Take
We currently have a Neutral recommendation on ViroPharma, which carries a Zacks #3 Rank (short-term Hold rating). We are pleased with the EC’s approval of Cinryze, which is already available in the US for the prevention of angioedema attacks in adolescent and adult patients with HAE.
We note that Cinryze revenues soared 62% year over year to $57 million during the first quarter of 2011 and accounted for 45% of ViroPharma’s revenues. Cinryze sales are expected to increase to $235–$260 million in 2011 from $177 million in 2010.
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