FDA Approves Luvox(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)

PALO ALTO, Calif., Feb. 28 - Today, Jazz
Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that the U.S. Food and Drug
Administration (FDA) has approved Once-A-Day LUVOX CR (fluvoxamine maleate)
Extended-Release Capsules for the treatment of social anxiety disorder
(SAD) and obsessive compulsive disorder (OCD) in adults. LUVOX CR is a
selective serotonin reuptake inhibitor (SSRI) that incorporates Elan’s
proprietary SODAS(R) (Spheroidal Oral Drug Absorption System) technology
designed to minimize peak-to-trough plasma level fluctuations over a
24-hour period.

    In clinical trials at the primary endpoint of 12 weeks, Once-A-Day
LUVOX CR provided statistically significant improvement vs. placebo in SAD
symptoms as measured by the LSAS (Liebowitz Social Anxiety Scale) and
statistically significant improvement vs. placebo in OCD symptoms as
measured by the Y-BOCS (Yale-Brown Obsessive Compulsive Scale)(1) (2) (3)
(4).

    “We are pleased to have FDA approval of this new, effective treatment
option for patients in the United States with SAD and OCD and our
proceeding towards launch by the end of this quarter,” said Samuel Saks,
M.D., chief executive officer of Jazz Pharmaceuticals. “As part of our
commitment to patients with these two serious and widely under-recognized
anxiety disorders, we are working with patient advocacy organizations to
raise awareness about these conditions and encourage patients to get
accurately diagnosed.”

    “The approval of Once-A-Day LUVOX CR (fluvoxamine maleate)
Extended-Release Capsules for social anxiety disorder and obsessive
compulsive disorder is important for the 15 million Americans with SAD and
the 2.2 million Americans with OCD, two underdiagnosed and undertreated
anxiety disorders,” said John H. Greist, M.D., distinguished senior
scientist, Madison Institute of Medicine and clinical professor of
psychiatry, University of Wisconsin Medical School. “Physicians have been
using immediate-release fluvoxamine for years to treat OCD patients. Now
having Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules
offers patients with SAD and OCD an additional option.”

    The FDA evaluated a data package involving approximately 600 patients
worldwide that included three clinical trials with positive outcomes
evaluating the efficacy and safety of LUVOX CR. These studies were:

    Social Anxiety Disorder
    –  Davidson, Jonathan, et al. Fluvoxamine-controlled release formulation
        for the treatment of generalized social anxiety disorder. J Clin
        Psychopharmacol 2004; 24:118-125.
    –  Westenberg, Herman, et al. A double-blind, placebo-controlled study of
        controlled-release fluvoxamine for the treatment of generalized social
        anxiety disorder. J Clin Psychopharmacol. 2004; 24:49-55.

    Obsessive Compulsive Disorder
    –  Hollander, Eric, et al. A double-blind, placebo-controlled study of
        the efficacy and safety of controlled-release fluvoxamine in patients
        with obsessive-compulsive disorder. J Clin Psychiatry. 2003;
        64:640-647.

    “SAD and OCD are serious, yet treatable conditions,” said Jerilyn Ross,
M.A., L.I.C.S.W., president and CEO, Anxiety Disorders Association of
America (ADAA). “We’re excited about new treatment options — both
medications and psychological — to help patients with these chronic and
undertreated anxiety disorders. Having treatment options benefits the
patient, and that’s what is most important.”

    LUVOX CR will be available in 100 mg and 150 mg dose strengths. Over
the next several weeks, Jazz Pharmaceuticals will continue to work closely
with Elan on the manufacturing of LUVOX CR for commercial launch.

    In January 2007, Jazz Pharmaceuticals licensed the right to market
Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules in the
U.S. from Solvay Pharmaceuticals. The license agreement provides for Jazz
Pharmaceuticals to pay Solvay Pharmaceuticals $20 million as a result of
the approval of LUVOX CR for both SAD and OCD and the approved expiry
dating of the product.

    The approval of LUVOX CR includes a post marketing commitment to
conduct a safety and efficacy study in adolescent patients with SAD and a
long-term safety and efficacy study in patients with SAD. The NDA for LUVOX
CR is being transferred to Jazz Pharmaceuticals.

    For more information about LUVOX CR, please visit
http://www.JazzPharmaceuticals.com

    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 they may embarrass themselves. Patients experience
physical symptoms of anxiety, including blushing, sweating, trembling and
nausea. (5) SAD affects an estimated 15 million American adults. (6)

    Obsessive Compulsive Disorder

    OCD is a chronic and debilitating anxiety disorder that is
characterized by recurrent, unwanted thoughts (obsessions) and/or
repetitive behaviors (compulsions) that are severe enough to cause
significant impairment. Patients are compelled to perform repetitive
behaviors such as hand washing, counting, checking or cleaning with the
goal of preventing obsessive thoughts or making them go away.5 OCD affects
approximately 2.2 million American adults.6

    Important Safety Information

    Antidepressants can increase suicidal thoughts and behaviors in
children, adolescents and young adults. Patients should call their doctor
right away if they experience new or worsening depression symptoms, unusual
changes in behavior, or thoughts of suicide.

    In clinical trials, the most commonly observed adverse events with an
incidence of greater than or equal to 5% and at least twice that of placebo
were nausea, somnolence, asthenia, diarrhea, anorexia, tremor, and
sweating. Overall, these side effects were mild to moderate in severity and
transient in nature. Other common adverse events with an incidence of
greater than or equal to 5% and at least twice that of placebo included
abnormal ejaculation and anorgasmia.

    The use of alosetron, tizanidine, thioridazine, or pimozide with LUVOX
CR Capsules is contraindicated. The use of MAO inhibitors in combination
with LUVOX CR Capsules or within 14 days of discontinuing treatment with
LUVOX CR Capsules is contraindicated. (see CONTRAINDICATIONS, WARNINGS and
PRECAUTIONS in full prescribing information.) LUVOX CR Capsules are also
contraindicated in patients with a history of hypersensitivity to
fluvoxamine maleate or any of its excipients.

    Clinical Measures

    LSAS: A clinician-rated, 24-item scale used to assess the range of
difficulties in social interaction (11 questions) and performance
situations (13 questions) that a patient with SAD may have.

    Y-BOCS: A clinician-rated, 10-item scale used to rate the severity of
obsessive compulsive symptoms and to monitor improvement during treatment.

    About Jazz Pharmaceuticals, Inc.

    Jazz Pharmaceuticals, Inc. is a specialty pharmaceutical company
focused on identifying, developing and commercializing innovative products
to meet unmet medical needs in neurology and psychiatry. Jazz
Pharmaceuticals will host an Investor Day on March 13, 2008 beginning at
10:00 a.m. Eastern Time/7:00 a.m. Pacific Time. The event will be available
by live audio webcast, and the accompanying presentation materials will
also be available on the investor relations section of Jazz
Pharmaceuticals’ website. For further information, please visit
http://www.JazzPharmaceuticals.com.

    “Safe Harbor” Statement under the Private Securities Litigation Reform
Act of 1995

    This press release contains forward-looking statements, including, but
not limited to, statements related to the planned commercial launch of
LUVOX CR and Jazz Pharmaceuticals’ continuing efforts, including
manufacturing to prepare for commercial launch. Words and phrases such as
“will,” “are proceeding” and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are based upon
Jazz Pharmaceuticals’ current expectations. Forward-looking statements
involve significant risks and uncertainties. Jazz Pharmaceuticals’ actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these risks
and uncertainties, which include, without limitation, risks related to when
or whether commercial launch of LUVOX CR will occur, Jazz Pharmaceuticals’
ability to attain market acceptance of LUVOX CR by physicians, patients and
third party payors, Jazz Pharmaceuticals’ dependence on single source
suppliers and manufacturers, and scaling up manufacturing of LUVOX CR to
commercial capacity. These and other risk factors are discussed under “Risk
Factors,” in the Quarterly Report on Form 10-Q for the quarter ended
September 30, 2007 filed by Jazz Pharmaceuticals with the Securities and
Exchange Commission on November 9, 2007. Jazz Pharmaceuticals undertakes no
duty or obligation to update any forward-looking statements contained in
this release as a result of new information, future events or changes in
its expectations.

    (C)2008 Jazz Pharmaceuticals, Inc. SODAS(R) is a registered trademark
of Elan Pharma International Limited, Ireland, a subsidiary of Elan
Corporation, plc (NYSE; ELN) LUVOX is a registered trademark of Solvay
Pharmaceuticals, Inc.

    (1)  Davidson J, Yaryura-Tobias J, DuPont R, et al. Fluvoxamine-controlled
         release formulation for the treatment of generalized social anxiety
         disorder. J Clin Psychopharmacol. 2004;24:118-125.
    (2)  Hollander E, Koran LM, Goodman WK, et al. A double-blind,
         placebo-controlled study of the efficacy and safety of
         controlled-release fluvoxamine in patients with obsessive-compulsive
         disorder. J Clin Psychiatry. 2003;64:640-647.
    (3)  LUVOX CR Prescribing Information. Jazz Pharmaceuticals, Inc., Palo
         Alto, CA;2008.
    (4)  Westenberg HGM, Stein DJ, Yang H, et al. A double-blind
         placebo-controlled study of controlled release fluvoxamine for the
         treatment of generalized social anxiety disorder. J Clin
         Psychopharmacol.2004;24:49-55.
    (5)  American Psychiatric Association. Diagnostic and Statistical Manual
         of Mental Disorders, 4th ed, revised. Washington, DC: American
         Psychiatric Association; 2000.
    (6)  Kessler RC, et al. Arch Gen Psychiatry. 2005; 62:593-602/ NIMH
         Website:
         http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-america.shtml#Anxiety, Date accessed December 14, 2007.

SOURCE Jazz Pharmaceuticals, Inc.