Depomed Comments on DM-1796 Pre-NDA Meeting and Horizant(R) Complete Response Letter
MENLO PARK, Calif., Feb 18, 2010 (BUSINESS WIRE) -- Depomed, Inc. (NASDAQ:DEPO) today announced that it has received final meeting minutes from the FDA for a pre-NDA meeting related to DM-1796 for postherpetic neuralgia (PHN) held in December 2009. Depomed also commented on recent public disclosures related to the Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant(TM)(gabapentin enacarbil) Extended-Release Tablets. Horizant is an investigational treatment for moderate-to-severe primary Restless Legs Syndrome developed by Xenoport, Inc. and licensed to GlaxoSmithKline.
Depomed noted that unlike Horizant, Depomed's proprietary extended release formulations of gabapentin are not new chemical entities that require additional carcinogenicity or other toxicology studies. Depomed expects an NDA for DM-1796 will be filed in the first quarter of this year under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. Depomed believes that no additional carcinogenicity studies will be required for the DM-1796 NDA because it will reference the same toxicology package that formed the basis of the approval of Neurontin(R) (gabapentin) for epilepsy and postherpetic neuralgia.
Depomed noted that gabapentin is a well-characterized compound that has been marketedfor epilepsy since 1993 and PHN since 2002. The compound has not shown a carcinogenicity signal in post-marketing experience involving approximately 20 million prescriptions annually.
DM-1796 Pre-NDA Meeting
In February 2010, Depomed received final meeting minutes from the pre-NDA meeting with the FDA related to DM-1796 for PHN held in December 2009. At the pre-NDA meeting, the FDA was asked to confirm that the preclinical toxicology package for DM-1796 was sufficient. Based upon the meeting minutes, Depomed believes that the toxicology package for DM-1796 appears sufficient to support the safety of DM-1796 provided certain manufacturing specifications are met.
Depomed licensed DM-1796, an investigational extended release formulation of gabapentin for PHN, to Solvay Pharmaceuticals, Inc. in the United States and other North American territories. Solvay Pharmaceuticals was acquired by Abbott Laboratories in February 2010.
Depomed also noted its SeradaTM product candidate, an investigational extended release formulation of gabapentin for menopausal hot flashes, addresses an unmet medical need in an area of women's health characterized by concerns linking the use of hormonal products to breast cancer and cardiovascular adverse events arising from post-marketing studies of those products. A Phase 3 trial for Serada is expected to begin by the end of April 2010. Any NDA for Serada will also reference Neurontin's toxicology package.
Investor Conference Call
Depomed will host a conference call tomorrow, February 19, 2010 at 8:30 am EST. Please dial in 5-10 minutes prior to the start time using the number and passcode below.
Dial-in number: 877-591-4959
An archived replay will available for up to 30 days on the company's website at http://www.depomed.com.
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 Solvay Pharmaceuticals, Inc. A New Drug Applications for DM-1796 is expected to be filed with the FDA in the first quarter of 2010. Product candidate SeradaTM 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, http://www.depomed.com.
"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 our clinical development programs; 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 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.
SOURCE: Depomed, Inc.
Sheilah Serradell, 650-462-5900
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