Jazz Pharmaceuticals, Inc. and Solvay Pharmaceuticals, Inc. announced a product license agreement under which Jazz Pharmaceuticals will have the right to market Luvox (fluvoxamine maleate) tablets and fluvoxamine maleate extended-release capsules in the United States, upon approval by the US Food and Drug Administration (FDA). Solvay Pharmaceuticals retains the right to market both products in other territories around the world.
Under the agreement, Jazz Pharmaceuticals has made an upfront payment and will make milestone payments to Solvay Pharmaceuticals upon the achievement of future regulatory and sales milestones. Jazz Pharmaceuticals will also pay royalties based on product sales.
Solvay Pharmaceuticals submitted a New Drug Application (NDA) in April 2006 to the FDA for fluvoxamine maleate extended-release capsules, an investigational compound being studied for the treatment of obsessive compulsive disorder (OCD) and generalized social anxiety disorder (SAD) in adults. Clinical data supporting the NDA are based on three well-controlled clinical trials evaluating the efficacy and safety of the compound in approximately 600 patients worldwide. The application is awaiting action by the FDA.
"The availability of an extended-release formulation may provide help for patients suffering from serious psychiatric conditions," said Robert M Myers, chief business officer of Jazz Pharmaceuticals. "We look forward to expanding our sales and marketing organization for this exciting opportunity."
"Luvox played a very important role in our neuroscience portfolio in the 1990s and we are confident that Jazz Pharmaceuticals will provide the expertise required to market this treatment in the US," said Laurence J Downey, MD, president and CEO of Solvay Pharmaceuticals Inc. "This agreement allows Solvay Pharmaceuticals to focus its resources on its other promising compounds in development that we hope will allow us to provide physicians with an array of neuroscience treatments that meet the needs of patients."