ViroPharma Inc. (VPHM) recently announced the initiation of a mid-stage trial of Cinryze as a treatment of acute antibody-mediated rejection (AMR) in recipients of donor-specific cross-match positive kidney transplants. The trial, which will enroll 20 patients, will evaluate the safety and efficacy of the candidate for the aforesaid indication.
In the trial, Cinryze’s safety, pharmacokinetics/pharmacodynamics, and clinical effect will be assessed after two weeks of treatment. Post-transplant, graft function and patient survival will be observed after six months of treatment with Cinryze.
Earlier during the month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Cinryze as a treatment for hereditary angioedema (HAE) in adolescents and adults.
The panel recommended European approval of the drug for pre-procedure prevention of angioedema attacks in patients suffering from HAE. Moreover, approval was also recommended for the routine prevention of angioedema attacks in patients with severe and recurrent attacks of HAE.
ViroPharma anticipates EU approval of the drug by the second quarter of 2011.
Cinryze is currently marketed in the United States for preventing angioedema attacks in adolescent and adult patients with HAE. Cinryze revenues of $52.5 million, during the fourth quarter of 2010, reflected an increase of 46%. Additionally, ViroPharma forecasts Cinryze sales to range from $235–$260 million in 2011.
Despite continuous development of Cinryze, we are concerned about Vancocin, one of the primary revenue contributors at ViroPharma, as the drug is presently not protected by any patent. Vancocin generics are yet to hit the market with the FDA requiring generic companies to conduct a bioequivalence study to gain approval for their versions.
We note that a proposed bioequivalence method for Vancocin is filed for approval with the FDA. If the method gets the regulatory body’s nod, the time required for a generic manufacturer to get a generic version of Vancocin approved will be reduced. This would lead to multiple generics entering the market with significant sales erosion of the drug.
Moreover, Vancocin could face competition from Optimer Pharmaceuticals Inc.’s (OPTR) fidaxomicin, which is currently under regulatory review in the US, with a target date set for May 30, 2011.
We currently have a Neutral recommendation on ViroPharma, which is supported by a Zacks #3 Rank (short-term Hold rating).
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