MENLO PARK, Calif.--(BUSINESS WIRE)--Depomed, Inc. (NASDAQ:DEPO - News) announced today a product license agreement under which Solvay Pharmaceuticals will have exclusive rights for DM-1796 (formerly Gabapentin GR®) for the treatment of pain in the United States, Canada, Mexico and Puerto Rico.
DM-1796 is an investigational gastric retentive formulation of gabapentin that is designed to achieve once-daily dosing and potentially reduce some of the side effects associated with gabapentin. Currently in Phase 3 development, DM-1796 is being studied for the treatment of postherpetic neuralgia.
“DM-1796 has the potential to offer patients suffering from persistent postherpetic neuralgia a new once daily treatment option with a more tolerable safety profile,” said Carl Pelzel, Depomed’s president and chief executive officer. “We are pleased to license this important new product to Solvay Pharmaceuticals, as DM-1796 will make a significant addition to Solvay’s portfolio, and reflects Solvay’s strategic focus on neuroscience development.”
Agreement Terms
Under the agreement announced today, Solvay Pharmaceuticals will make an upfront payment of $25 million to Depomed, and will make milestone payments to Depomed, subject to the fulfillment of future regulatory and sales milestones, of up to an additional $370 million (up to $70 million in regulatory milestones and up to $300 million in sales milestones). Solvay Pharmaceuticals will also pay a royalty of 14 to 20 percent, depending on product sales.
Depomed will remain responsible for completion of the ongoing Phase 3 clinical trial for DM-1796 in PHN, and will be responsible for certain other regulatory support activities through NDA approval. Solvay Pharmaceuticals will be responsible for NDA filing and has the option to develop DM-1796 in further pain indications other than PHN. If Solvay Pharmaceuticals elects to develop DM-1796 in fibromyalgia, Depomed has a right of first negotiation for co-promote rights in the OB/GYN field upon fibromyalgia indication regulatory approval.
Consummation of the transaction is anticipated to occur in the fourth quarter of 2008 and is contingent solely on completion of review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. The upfront payment to Depomed is due 60 days following the completion of the HSR review.
“This transaction achieves an important strategic goal of partnering DM-1796 with a top tier partner, while maintaining our ownership of DM-5689 for menopausal hot flashes,” said Thadd Vargas, Depomed’s vice president, Business Development. “In addition, it provides Depomed with significant resources to fund and advance our business, particularly in these challenging economic times.”
Clinical Development Status
In March 2008, Depomed initiated dosing of the first patient in a 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. The current anticipated submission date for the DM-1796 NDA to the U.S. Food and Drug Administration is the fourth quarter of 2009.
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 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 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 2007 sales were EUR 2.6 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 2007, its consolidated sales amounted to EUR 9.6 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.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with two approved products on the market and other product candidates in its pipeline. The company utilizes its proven, proprietary AcuFormTM drug delivery technology 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. 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 and is being marketed in the United States within the urology, Ob/Gyn and long-term care specialties by Watson Pharmaceuticals. Product candidate DM-1796 is in clinical development for the treatment of neuropathic pain and has been licensed to Solvay Pharmaceuticals. Product candidate DM-5689 is in clinical development for menopausal hot flashes. Additional information about Depomed may be found on its website, www.depomedinc.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.
Contact:
Depomed, Inc. Sheilah Serradell, 650-462-5900 (Investor Relations) investorrelations@depomed.com
Source: Depomed, Inc.
