ViroPharma signs agreement with Sanquin Blood Supply Foundation to develop and commercialize Cinryze

Jan 12 2010

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."

There were no upfront payments associated with this agreement. ViroPharma agreed to modify the existing manufacturing fee, establish minimum purchase requirements, fund research efforts at Sanquin at the rate of 1MM Euros per year for five years, and provide an additional loan to Sanquin to fund capacity expansions.

ViroPharma has been granted the exclusive right and license to research, develop, obtain regulatory approvals and commercialize Cinryze in all countries in Europe and rest of world, other than certain European and ROW territories in which Sanquin has existing relationships and European territories in which Sanquin retains the right to market their drug Cetor. In addition, ViroPharma also acquired the right to market Cetor in Europe other than the excluded territories if Cinryze does not receive marketing authorizations in such countries. ViroPharma also has been granted the right to develop Cinryze for all potential new indications.

Sanquin and ViroPharma have also modified the terms of the existing Distribution and Manufacturing Services Agreement with Sanquin related to the manufacture of Cinryze including those related to second sourcing, minimum purchase requirements and price.

ViroPharma has filed a report on Form 8-K containing additional information with respect to the U.S. and ROW Agreements, and intends to file the U.S. and ROW Agreements as exhibits in an upcoming filing with the SEC.