Depomed Announces US FDA Approval of Once-Daily Tablets for Post-Herpetic Neuralgia
Depomed, Inc. recently announced the US FDA has approved Gralise (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles. Gralise was developed by Depomed under the code name DM-1796 and is licensed to Abbott Products, Inc. in the
“The approval of Gralise is a major step toward achieving our key strategic objective of sustainable profitability in 2011 and beyond,” said Carl Pelzel, President and CEO of Depomed. “I’d like to thank everyone on the Depomed and Abbott teams involved in the development and approval of this important therapy for their hard work and dedication.”
“We are delighted with the approval of Gralise, which marks the third FDA approval of a product developed by Depomed,” added Michael Sweeney, MD, Vice President of Research and Development for Depomed. “Furthermore, the FDA has granted Gralise Orphan Drug status, recognizing it as an important treatment option for patients who suffer from the pain of PHN. We are also very pleased with the product label FDA has approved.”
“The Gralise formulation of gabapentin allows for once-a-day dosing and a tolerability profile that will be a positive addition to physicians’ treatment armamentarium,” said Gordon Irving, MD, Medical Director of the Swedish Pain and
Depomed entered into a license agreement for Gralise (DM-1796) with Solvay Pharmaceuticals in November 2008. Abbott Products assumed the license agreement, and Solvay’s obligations under it as a result of the acquisition of Solvay’s pharmaceutical business by Abbott Laboratories, which was completed in February 2010. In addition to the $48 million milestone payment for approval of Gralise, the license agreement calls for royalties of 14% to 20% on product sales, and sales milestone payments of up to $300 million.
Depomed announced this January that the company had initiated mediation with Abbott Laboratories, the parent company of Abbott Products, regarding Abbott’s commercialization obligations under the license agreement.
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