Solvay Pharmaceuticals, Inc. and Jazz Pharmaceuticals, Inc. Announce License Agreement for LUVOX® (fluvoxamine maleate) Tablets and Fluvoxamine Maleate Extended-Release Capsules in the United States
MARIETTA, Ga. - (February 1, 2007) – Solvay Pharmaceuticals, Inc. and Jazz Pharmaceuticals, Inc., announced today a product license agreement under which Jazz Pharmaceuticals will have the right to market LUVOX® (fluvoxamine maleate) Tablets and fluvoxamine maleate extended-release capsules, upon approval by the Food and Drug Administration (FDA), in the United States. Solvay Pharmaceuticals will retain the right to market both products in other territories around the world.
A product of Solvay Pharmaceuticals’ innovative research in psychiatry, fluvoxamine was introduced in 1983 in Europe as one of the very first selective serotonin reuptake inhibitors (SSRI). This class of compounds is used for the treatment of depression, anxiety and other related disorders. The company’s first global product, fluvoxamine was later introduced in the United States in 1994 and was the first SSRI marketed in Japan when it was introduced in 1999. Prescribed to more than 50 million people, fluvoxamine is currently registered in 90 countries around the world.
Most recently, Solvay Pharmaceuticals submitted a New Drug Application (NDA) in April 2006 to the FDA for fluvoxamine extended-release capsules, an investigational compound being studied for the treatment of generalized social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adults. The clinical data supporting the NDA are based on three adequate and well-controlled clinical trials evaluating the efficacy and safety of the compound in an additional 600 patients worldwide.
Under the agreement announced today, Jazz Pharmaceuticals has made an upfront payment and will make milestone payments to Solvay Pharmaceuticals, subject to the fulfillment of future regulatory and sales milestones. Jazz Pharmaceuticals will also pay royalties based on product sales.
“LUVOX played a very important role in our neuroscience portfolio in the 1990’s and we are confident that Jazz Pharmaceuticals will provide the expertise required to market this treatment in the future," said Laurence J. Downey, M.D., 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.”
"The availability of the 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."
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. The company seeks 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 2005 sales were EUR 2.3 billion and it employs approximately 10,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 30,000 people in 50 countries. In 2005 its consolidated sales amounted to EUR 8.6 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY (Euronext : SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the Euronext stock exchange in Brussels. Details are available at www.solvay.com.
