Victory Pharma, Inc. Announces FDA Accepts MGX006 NDA for Review

Mon Jul 13, 2009 7:17am EDT
 
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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 rug, 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.



SOURCE  Victory Pharma, Inc.

David J. Parker, Chief Financial Officer of Victory Pharma, Inc., 
+1-858-720-4524

 

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