ViroPharma Incorporated (Nasdaq: VPHM) today announced that it has signed an agreement with Sanquin Blood Supply Foundation for rights to develop, file regulatory dossiers, and commercialize Cinryze(TM) (C1 esterase inhibitor [human]) for hereditary angioedema (HAE) as well as for potential new indications in certain European and rest of world (ROW) territories. This agreement significantly expands ViroPharma's rights to commercialize Cinryze in regions beyond the originally licensed territories of North America, most of the countries in South America, and Israel and allows for development of potential new indications. ViroPharma and Sanquin have also amended the existing Distribution and Manufacturing Services Agreement related to the manufacture of Cinryze for distribution in the United States.
Cinryze was approved in October 2008 by the U.S. Food and Drug Administration for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema. ViroPharma has received agreement on its paediatric investigation plan, or PIP, from the European Medicines Agency's (EMEA) Paediatric Committee, and has been granted European orphan medicinal product designation for Cinryze. Cinryze is not currently approved in any country other than the United States.
"We have developed an outstanding relationship with Sanquin during the first year of the launch of Cinryze in the United States, and the expansion of our collaboration represents a significant step in our combined efforts to expand the potential markets in which we may commercialize Cinryze," commented Vincent Milano, ViroPharma's president and chief executive officer. "Hereditary angioedema is a disease suffered by patients across the globe, and the completion of this agreement is an important next step toward approval and launch of Cinryze in countries beyond the U.S."
Continued Milano, "In addition to our opportunities to expand the use of Cinryze in U.S. patients suffering from HAE, these newly expanded rights provide new opportunities for growth including commercializing the product in Europe and ROW, expanding the labeled indication for Cinryze to potentially include other C1 mediated diseases, and developing new forms of administration for this important drug."