MENLO PARK, Calif., Aug. 3, 2010 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO - News) today announced that pursuant to the Hatch-Waxman Act, the 45-day period for filing a patent infringement suit under the Act, and thus initiating a 30-month stay on the FDA’s ability to approve the DM-1796 NDA, has expired. Depomed has confirmed with Pfizer Inc. that no suit under the Act has been filed. DM-1796 is an extended release, once-daily tablet formulation of gabapentin for post-herpetic neuralgia developed by Depomed.
“We look forward to a potential approval of DM-1796 in the first quarter of next year,” commented Carl A. Pelzel, Depomed’s president and chief executive officer.
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 Serada(R) is in Phase 3 clinical development for menopausal hot flashes. GLUMETZA(R) (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(R) 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 regulatory matters related to DM-1796; our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-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.
Contact:
Depomed, Inc. Sheilah Serradell 650-462-5900 sserradell@depomed.com
