JAZZ PHARMACEUTICALS, INC. AND SOLVAY PHARMACEUTICALS, INC. ANNOUNCE LICENSE AGREEMENT FOR LUVOX® (FLUVOXAMINE MALEATE) TABLETS AND FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES IN THE UNITED STATES
JAZZ PHARMACEUTICALS, INC. AND SOLVAY PHARMACEUTICALS, INC. ANNOUNCE LICENSE AGREEMENT FOR LUVOX® (FLUVOXAMINE MALEATE) TABLETS AND FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES IN THE UNITED STATES
February 01, 2007
Palo Alto, California – February 1, 2007 – Jazz Pharmaceuticals, Inc. and Solvay 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 in the United States, upon approval by the U.S. 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 U.S.," 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.”
About Obsessive Compulsive Disorder Obsessive compulsive disorder (OCD), an anxiety disorder, is characterized by persistent, unwanted thoughts (obsessions) and repetitive behaviors or rituals (compulsions). OCD is estimated to affect two to three million adults in the United States, with fewer than half of these individuals diagnosed and treated. Approximately 50 percent of OCD patients have a concomitant psychiatric disorder, such as other anxiety disorders or depression. OCD has long been recognized by psychiatrists as one of the most difficult disorders to treat.
About Social Anxiety Disorder
Social anxiety disorder (SAD), or social phobia, is characterized by the fear and avoidance of social or performance situations where patients feel that others may scrutinize them and the patients may embarrass themselves. In addition to anxiety, patients experience physical symptoms including blushing, sweating, trembling and nausea. SAD is under diagnosed, with fewer than 15 percent of the estimated five million adults suffering from SAD in the United States diagnosed and treated. More than 70 percent of SAD patients also suffer from another psychiatric condition.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is focused on helping patients by meeting unmet medical needs in neurology and psychiatry with important and innovative therapeutic products. Jazz Pharmaceuticals is aggressively building its product portfolio through a combination of commercialization and development activities. Based in Palo Alto, California, the company is committed to working closely with patients, patient advocacy groups and healthcare professionals. For further information, please visit www.JazzPharmaceuticals.com.
Contacts:
Jazz Pharmaceuticals, Inc.
BCC Partners
Karen L. Bergman, 650-575-1509
Michelle Corral, 415-794-8662
Jazz Pharmaceuticals, Inc.
Matthew Fust
Chief Financial Officer
650-496-3777
mediainfo@jazzpharma.com
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 U.S.," 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.”
About Obsessive Compulsive Disorder Obsessive compulsive disorder (OCD), an anxiety disorder, is characterized by persistent, unwanted thoughts (obsessions) and repetitive behaviors or rituals (compulsions). OCD is estimated to affect two to three million adults in the United States, with fewer than half of these individuals diagnosed and treated. Approximately 50 percent of OCD patients have a concomitant psychiatric disorder, such as other anxiety disorders or depression. OCD has long been recognized by psychiatrists as one of the most difficult disorders to treat.
About Social Anxiety Disorder
Social anxiety disorder (SAD), or social phobia, is characterized by the fear and avoidance of social or performance situations where patients feel that others may scrutinize them and the patients may embarrass themselves. In addition to anxiety, patients experience physical symptoms including blushing, sweating, trembling and nausea. SAD is under diagnosed, with fewer than 15 percent of the estimated five million adults suffering from SAD in the United States diagnosed and treated. More than 70 percent of SAD patients also suffer from another psychiatric condition.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is focused on helping patients by meeting unmet medical needs in neurology and psychiatry with important and innovative therapeutic products. Jazz Pharmaceuticals is aggressively building its product portfolio through a combination of commercialization and development activities. Based in Palo Alto, California, the company is committed to working closely with patients, patient advocacy groups and healthcare professionals. For further information, please visit www.JazzPharmaceuticals.com.
Contacts:
Jazz Pharmaceuticals, Inc.
BCC Partners
Karen L. Bergman, 650-575-1509
Michelle Corral, 415-794-8662
Jazz Pharmaceuticals, Inc.
Matthew Fust
Chief Financial Officer
650-496-3777
mediainfo@jazzpharma.com