ViroPharma Inc. recently announced that the Canadian regulatory body has granted priority review status to the company’s new drug submission (NDS) for Cinryze. ViroPharma is seeking the drug’s approval for the treatment of prevention, pre-procedure prevention, and treatment of attacks of hereditary angioedema (HAE) in patients who are six years or older.
The company expects Health Canada to complete its review of Cinryze in the second half of 2012.
We note that Cinryze is currently marketed in the US for the prevention of angioedema attacks in adolescent and adult patients with HAE. In the European Union (EU), the same drug is marketed for the treatment of prevention, pre-procedure prevention, and treatment of attacks of HAE in adolescents and adult patients.
We view this development as a positive for ViroPharma, which expects to book $310 – $330 million of US Cinryze sales in 2012. The drug’s approval in Canada will bring in incremental sales for the company.
ViroPharma has 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. Last month, the companies reported positive top-line data from a mid-stage trial on the drug. The phase II study was designed to evaluate the safety, and pharmacokinetics and pharmacodynamics of the subcutaneous formulation of Cinryze in combination with Halozyme's Enhanze technology, in patients suffering from HAE.
The Enhanze technology is a proprietary drug-delivery platform, using Halozyme's recombinant human hyaluronidase enzyme (rHuPH20). This proprietary rHuPH20 enzyme facilitates the absorption and dispersion of drugs or fluids that are injected under the skin.
We currently have a Zacks #1 Rank (short-term Strong Buy rating) on ViroPharma. We believe continued uptake of Cinryze (hereditary angioedema) in the US, launch of Buccolam (seizure) and Cinryze in the remaining European countries, and the potential EU launch of Plenadren (adrenal insufficiency in adults), later in 2012, will help boost the company’s revenues.
Moreover, the label update of Vancocin (clostridium difficile infection), to include safety and efficacy data from 260 patients with C. difficile associated diarrhea (CDAD), who were treated with Vancocin in two pivotal studies of Sanofi’s (SNY - Analyst Report) investigational drug, tolevamer, has brought three years of marketing exclusivity (until the end of 2014) for the drug.
However, we have a Neutral recommendation on ViroPharma, for the longer term, as the company does not have any late-stage pipeline candidate in its portfolio to help drive long-term growth, post the launch of Plenadren. We believe that ViroPharma will have to continue making acquisitions or entering into deals in order to fill this gap.