MENLO PARK, Calif., June 28, 2010 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO) today announced that it has received a $10 million milestone payment from Abbott Products, Inc., its licensee of DM-1796, for the U.S. Food and Drug Administration's acceptance for filing of the New Drug Application (NDA) for DM-1796 for the management of postherpetic neuralgia (PHN), or pain after shingles.
DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects. The FDA has set the Prescription Drug User Fee (PDUFA) goal date in the first quarter of 2011 for action on the NDA.
"This $10 million milestone payment strengthens our balance sheet and allows us to further advance our other pipeline programs," said Carl Pelzel, president and chief executive officer of Depomed.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with one product candidate through Phase 3 clinical development, another in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 has completed Phase 3 clinical development and has been licensed to Abbott Products, Inc. Product candidate SeradaTM is in Phase 3 clinical development for menopausal hot flashes. GLUMETZA® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of Acuform-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Additional information about Depomed may be found on its website, www.depomed.com.
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"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to FDA review of the NDA for DM-1796; potential benefits of DM-1796;our collaboration with Abbott Products, Inc. related to DM-1796; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and Current Reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.