Victory Pharma, Inc. Announces FDA Accepts MGX006 NDA for Review
SAN DIEGO, July 13 /PRNewswire/ -- Victory Pharma, Inc. ("Victory") announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Victory's lead investigational drug, MGX006. If approved, MGX006 will provide patients and healthcare providers the advantage of a proven antiemetic agent combined with a proprietary formulation ideally suited for the treatment of nausea and vomiting.
"Acceptance of the MGX006 NDA is a significant milestone, it demonstrates Victory's ability to grow its commercial portfolio via internal product development in addition to in-licensing products," said Matt Heck, Chief Executive Officer of Victory. "Pending FDA approval, we are planning for a first half of 2010 product launch, allowing Victory to further leverage its 150 person field sales organization. Given many patients suffering from pain also suffer from emesis, there is a good fit between MGX006 and Victory's growing, pain management franchise."
Approximately 25 million prescriptions are written annually in the U.S. for anti-emetic therapeutics. The vast majority of these prescriptions are for traditional, oral solid drug formulations, which can be problematic among patients with emesis.
"We believe the attributes of MGX006 will provide an important alternative for patients suffering from nausea and vomiting of various etiologies," said Dr. Shawn Scranton, Vice President, Scientific Operations. "We look forward to working closely with the FDA on a timely approval."
About Victory Pharma
Founded in 2003, Victory Pharma, Inc. is a privately held specialty pharmaceutical company headquartered in San Diego, CA focused on acquiring, developing, and marketing products to treat pain and related conditions. Victory markets its lead product, NAPRELAN(R) (naproxen sodium) Controlled-Release Tablets and other pain products to pain management specialists, rheumatologists, orthopedic surgeons, and selected primary care physicians through its physician office-based field sales force. Victory is also developing proprietary products for the treatment of chronic pain and common opiate- induced side effects Further information regarding Victory Pharma is available at www.victorypharma.com.
NAPRELAN(R) is a trademark of Elan Corporation, plc.
