Valeant Product Producer Progenics Announce European Approval For RELISTOR To Treat All Opioid Induced Constipation

Valeant Pharmaceuticals International, Inc. VRX VRX and Progenics Pharmaceuticals, Inc. PGNX today announced that the European Commission has approved RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection for the treatment of opioid-induced constipation (OIC) when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older. The decision effective May 27, 2015 is applicable to all 28 European Union member states plus Iceland and Norway and includes an additional one year of marketing protection. The European Commission decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) which cited that RELISTOR offers a major contribution to patient care in comparison to existing therapies. RELISTOR was first approved in Europe in 2008 for the treatment of OIC in advanced illness patients, and is currently approved in more than 50 countries including the United States. Mark Baker, Chief Executive Officer of Progenics, stated, "This approval represents a milestone for the RELISTOR franchise, significantly expanding the number of patients in Europe who can benefit from this drug. OIC can be a tremendous burden, affecting a patient's ability to function adequately, but RELISTOR provides patients with the ability to effectively treat their symptoms. Importantly the European approval also recognized the benign safety profile of RELISTOR."