SAN DIEGO, March 25, 2013 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX) today announced that the European Commission (EC) has designated MST-188 as an orphan medicinal product for the treatment of sickle cell disease. This decision follows a positive opinion adopted by the Committee for Orphan Medicinal Products (COMP) recommending such designation.
Brian M. Culley , Chief Executive Officer, said: "Now that we actively are recruiting patients in EPIC, our pivotal phase 3 study of MST-188 in sickle cell disease, we intend to pursue strategic alliances more aggressively. We believe orphan designation and the expectation of 10 years of marketing exclusivity in the EU will enhance partnering interest in Europe. In addition to enabling development in multiple countries and enhancing the overall commercial opportunity for MST-188, partnerships will help fund its development within the U.S."
Mr. Culley continued: "Our recently announced plans to investigate MST-188 in acute limb ischemia, a complication of peripheral arterial disease, also may bolster our partnering efforts. Indeed, we already have been approached by at least one pharmaceutical company that wished to discuss our near- and long-term plans in arterial disease, which we announced just three weeks ago."
About Orphan Medicinal Product Designation
The COMP, one of seven scientific committees of the European Medicines Agency (EMA), is responsible for reviewing applications from companies seeking "orphan medicinal product designation" and making recommendations to the EC regarding these applications. Orphan medicinal product designation is for investigational medicines designed to treat rare diseases that are life-threatening or chronically debilitating and for which there is no satisfactory method of treatment or, if such a method exists, for investigational medicines that
|SOURCE Mast Therapeutics, Inc.|
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