Victory Pharma, Inc. has announced that the FDA has acceptedfor review the New Drug Application (NDA) for Victory’s lead investigationaldrug, MGX006. If approved, MGX006 will provide patients and healthcareproviders the advantage of a proven antiemetic agent combined with aproprietary formulation ideally suited for the treatment of nausea andvomiting. “Acceptance of the MGX006 NDA is a significant milestone, it demonstratesVictory’s ability to grow its commercial portfolio via internal productdevelopment in addition to in-licensing products,” said Matt Heck, ChiefExecutive Officer of Victory. “Pending FDA approval, we are planning for afirst half of 2010 product launch, allowing Victory to further leverage its150 person field sales organization. Given many patients suffering from painalso suffer from emesis, there is a good fit between MGX006 and Victory’sgrowing, pain management franchise.” Approximately 25 million prescriptions are written annually in the U.S.for anti-emetic therapeutics. The vast majority of these prescriptions arefor traditional, oral solid drug formulations, which can be problematic amongpatients with emesis. “We believe the attributes of MGX006 will provide an important alternativefor patients suffering from nausea and vomiting of various etiologies,” saidDr. Shawn Scranton, Vice President, Scientific Operations. “We look forwardto working closely with the FDA on a timely approval.”
