THE MICHAEL J. FOX FOUNDATION AWARDS DEPOMED A SECOND DEVELOPMENT GRANT IN PARKINSON'S DISEASE
MENLO PARK, Calif. - October 11, 2010 - Depomed, Inc. (NASDAQ:DEPO) announced today that it has been awarded a clinical grant by The Michael J. Fox Foundation under its Clinical Intervention Awards 2010 program. The modest grant amount supports Depomed in the development of a gastric retentive extended-release tablet of levodopa/carbidopa that targets constant blood levels of levodopa compared to current therapy while reducing dosing frequency and maintaining effectiveness in controlling Parkinson's symptoms. Maintaining constant blood levels of levodopa could result in a reduction of side effects (dyskinesia, uncontrolled movements when levels are too high) and symptoms (akinesia, lack of initiation of movement when levels are too low) that are caused by current therapy.
"We are grateful to The Michael J. Fox Foundation for their continued support since we received a preclinical grant from them in July 2008. We look forward to working with the Foundation on advancing our early-stage Parkinson's program that is based on our Acuform® drug delivery technology," said Carl A. Pelzel, president and chief executive officer of Depomed.
About Depomed's Clinical Trial
Two different gastric retentive extended-release tablet formulations that deliver levodopa and carbidopa with different release profiles over 8 hr will be administered to Parkinson's disease patients following a meal. Blood samples will be obtained for up to 24 hr following administration of the tablets and the concentrations of levodopa and carbidopa will be determined. In addition, a finger tapping test will be conducted following each blood sample to determine the effectiveness of the treatment. The blood concentration data and finger tapping results obtained after administration of the gastric retentive tablets will be compared to a marketed non-gastric retentive extended-release formulation of levodopa/carbidopa that is currently being used in the treatment Parkinson disease patients. If successful, this trial will result in selection of a tablet formulation to be advanced to later stage clinical efficacy and safety studies in Parkinson's disease patients.
About Parkinson's Disease
Parkinson's disease is a chronic, degenerative neurological disorder that affects nearly one million Americans, with significant prevalence growth expected over the next 25 years due to aging population demographics. Nearly 5 million worldwide are estimated to have Parkinson's. While the average age at onset is 60, disease onset starts by age 40 in an estimated five to 10 percent of patients, and people as young as 30 can also be affected. Current therapies are effective in addressing only the mild/moderate motor symptoms of the disease and have significant long-term side effects. There are no drugs available that target the numerous non-motor aspects of the disease or that modify the underlying degenerative process.
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. A New Drug Application for DM-1796 was accepted by the FDA in the second quarter of 2010. Product candidate Serada® 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, http://www.depomed.com.
About The Michael J. Fox Foundation for Parkinson's Research (MJFF)
Founded in 2000, The Michael J. Fox Foundation for Parkinson's Research is dedicated to ensuring the development of a cure for Parkinson's disease within the coming decade through an aggressively funded research agenda. The Foundation has funded over $200 million in research to date.
About MJFF's Clinical Intervention Awards
The Clinical Intervention Awards program fund clinical intervention trials of up to three years for promising therapeutic approaches with potential to significantly improve the treatment of Parkinson's disease (PD). Ideal proposed clinical intervention trials focus on tests of novel treatments that can slow or halt disease progression, or that can greatly reduce PD motor and non-motor symptoms beyond (and without the complications of) current standards of care.
"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, 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.
CONTACT: Sheilah Serradell
Minimum 15 minutes delayed.