Depomed Announces FDA Approval of Merck's JANUMET(R) XR That Accesses Depomed Patents Licensed to Merck


MENLO PARK, Calif., Feb. 3, 2012 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO) today announced that Merck disclosed on February 2, 2012 that the U.S. Food and Drug Administration (FDA) approved JANUMET® XR (sitagliptin and metformin hydrochloride (HCl) extended-release) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA® (sitagliptin), with extended-release metformin. JANUMET® XR provides a convenient once-daily treatment option for healthcare providers and patients who need help to control their blood sugar. Depomed has provided Merck a license to certain of Depomed's patents directed to metformin extended release technology for JANUMET® XR pursuant to the terms of the license agreement signed with Merck in 2009. Depomed received $10 million upon signing the license agreement and $2.5 million upon Merck's filing of the JANUMET® XR New Drug Application with the FDA. Depomed will receive modest, single-digit royalties on net product sales of JANUMET® XR through the expiration date of the licensed patents.

About Depomed

Depomed, Inc. is a specialty pharmaceutical company with two approved and marketed products. GraliseTM (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized 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 release of medications to the upper gastrointestinal tract when dosed with food. 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 the efforts of our collaboration partners to commercialize products; our research and development efforts; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. The achievement of those plans and objectives involves risks and uncertainties including, but not limited to, risks and uncertainties related to the timing and outcome of clinical trials, launch and market acceptance of Gralise; 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 and most recent Quarterly Report on Form 10-Q. 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.


            

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