Raptor Pharma Wins Positive Opinion for Orphan Drug Exclusivity from EU Committee for PROCYSBI

Raptor Pharmaceutical Corp.

today announced that it has received a positive opinion from the European Union (EU) Committee for Orphan Medicinal Products (COMP) recommending orphan drug exclusivity for PROCYSBI^® (mercaptamine) gastro-resistant hard capsules for the treatment of proven nephropathic cystinosis. Final adoption of the opinions on drug approval and orphan exclusivity are expected from the European Commission in the coming months. "The positive opinion from COMP is another welcome milestone for Raptor and PROCYSBI as we seek to bring this important new product to European patients who suffer from cystinosis," said Christopher M. Starr, Ph.D., Raptor's chief executive officer. "Orphan designation will provide the company with 10 years of marketing exclusivity in the European Union alongside our IP estate." The EMA's Orphan Drug Exclusivity is designed to provide regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or debilitating conditions with a prevalence in the European Union (EU) of not more than five in 10,000. Orphan medicinal products receive 10 years of market exclusivity in the EU after receiving marketing authorization.