“We are glad that we successfully arrived at another milestone that brings Depomed closer to potential milestone payments related to the development of DM-1796 and further royalties and sales milestones upon its approval. We remain excited to have Solvay Pharmaceuticals as a strong and committed partner in the neuroscience field, we share with their expectation that DM-1796 could become a significant product for the treatment of neuropathic pain,” said Carl A. Pelzel, Depomed’s president and chief executive officer. Dr. Michael Sweeney, Depomed’s vice president, Research and Development, added, “ I would like to thank all clinical investigators, patients, and Depomed employees whose dedication to DM-1796 enabled us to complete enrollment as planned. We look forward to the top-line results of the trial in the fourth quarter of this year.”
Clinical Development Status
In March 2008, Depomed initiated dosing of the first patient in this Phase 3 clinical trial for DM-1796 for PHN. The study is a randomized, double-blind, placebo-controlled study of approximately 450 PHN patients. Patients in the study are randomized into two treatment arms: placebo, or 1800mg of DM-1796 dosed once daily.
Postherpetic Neuralgia (PHN)
Postherpetic neuralgia (PHN) is a persistent neuropathic pain condition. It is caused by nerve damage after a shingles, or herpes zoster, viral infection and afflicts approximately one in five patients diagnosed with shingles (~ 150,000 individuals) in the U.S. The incidence of PHN increases in elderly patients, with 75 percent of those over 70 years old who have shingles developing PHN. The pain associated with PHN reportedly can be so severe that some patients are unable to resume normal activities for months.
Leveraging Depomed's Gastric Retentive Technology
Gabapentin available on the market today is formulated for immediate release (IR). Upon ingestion, the entire administered dose is released into the stomach allowing for it to be rapidly absorbed into the blood. This rapid absorption leads to peak concentrations of the active ingredient, which gives rise to commonly experienced side effects including dizziness and daytime sleepiness. Patients taking immediate release formulations of gabapentin frequently need to take it three to four times a day to effectively manage their pain.
Formulated with gastric retentive technology, DM-1796 is designed for targeted, controlled release to the upper GI tract over a six to eight hour period. This extended release allows for the drug to be gradually absorbed into the blood, reducing the likelihood of peak concentrations and potentially resulting in fewer side effects than seen with immediate release formulations. Greater treatment tolerability and a more convenient dosing regimen made possible with this technology could potentially translate into greater patient compliance and ultimately better pain management.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with two product candidates in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 is in Phase 3 clinical development for the treatment of neuropathic pain and has been licensed to Solvay Pharmaceuticals. 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. Proquin® XR (ciprofloxacin hydrochloride) is approved in the United States for the once-daily treatment of uncomplicated urinary tract infections. 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.
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com.
Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. These companies seek to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, and men's and women's health. Its 2008 sales were EUR 2.7 billion and it employs more than 9,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.
Solvay is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs more than 28,000 people in 50 countries. In 2008, its sales amounted to EUR 9.5 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the NYSE Euronext stock exchange in Brussels. Details are available at www.solvay.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 program for DM-1796; potential benefits of 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 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.
Depomed, Inc.
Sheilah Serradell, 650-462-5900
sserradell@depomed.com