Microsoft word - press release luvox.doc

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

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
[email protected]

Source: http://www.bpoc.com/news/Press%20Release%20Luvox.pdf