Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a new indication for 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. Additionally, the Committee has recommended a one-year extension of data/marketing protection for RELISTOR, to 11 years from the date of approval, citing the fact that RELISTOR offers a major contribution to patient care in comparison to existing therapies.
The CHMP is responsible for reviewing medicinal product applications for safety, quality and efficacy. The CHMP's positive opinion on RELISTOR will be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The final decision will be applicable to all 28 European Union member countries plus Iceland and Norway. If approved, it is anticipated that RELISTOR will be immediately available to this newly expanded population of patients in the EU using opioids to control chronic non-cancer pain.
"The positive CHMP opinion brings RELISTOR one step closer to providing a treatment for the millions of patients in Europe who suffer from debilitating constipation while taking opioids for chronic non-cancer pain," said Mark Baker, Chief Executive Officer of Progenics. "RELISTOR offers a meaningful benefit to patients who are unable to manage their constipation with less effective laxative therapies."
Tage Ramakrishna, M.D., Chief Medical Officer of Valeant, added, "Today's positive opinion recognizes the clinical benefit of RELISTOR, which treats the underlying cause of OIC without interfering with the centrally acting analgesic properties of the opioid. We are committed to realizing the full potential of this important franchise, and if approved, we will work quickly to bring this needed medicine to European patients."
SOURCE Valeant Pharmaceuticals International, Inc.