Jazz Pharmaceuticals and UCB announce second Phase III study of sodium oxybate in patients with fibromyalgia meets

PALO ALTO, CA and BRUSSELS, BELGIUM, Jun 24 (MARKET
WIRE) --
press release, regulated information -- Jazz Pharmaceuticals, Inc.
(NASDAQ: JAZZ) and UCB (Euronext Brussels: UCB) announced today positive
preliminary top-line results from the second of two Phase III clinical
trials of sodium oxybate (JZP-6) for the treatment of fibromyalgia.
Confirming the positive results from the first Phase III study, this
international, placebo-controlled trial of sodium oxybate to treat
fibromyalgia achieved its key endpoints. As in the first randomized,
double-blind fibromyalgia study, sodium oxybate significantly decreased
pain and fatigue and improved daily function and patient global
impression of change. Sodium oxybate has not been evaluated by regulators
for the treatment of fibromyalgia and is not approved for this use.

"Fibromyalgia is a chronic illness, characterized by widespread pain,
unrefreshing sleep, chronic fatigue, and psychological distress," said I.
Jon Russell, M.D., Ph.D., lead investigator in the first Phase III study
and Associate Professor of Medicine, Division of Clinical Immunology and
Rheumatology, and Director, University Clinical Research Center,
University of Texas Health Science Center at San Antonio. "Sodium oxybate
has shown a positive effect on a number of the symptoms of fibromyalgia,
and thus could have a significant impact on patients' quality of life."

The second 14-week Phase III trial, conducted in the United States and
seven European countries, included 573 adult patients with fibromyalgia
randomized to one of three treatment arms: sodium oxybate 4.5 g/night,
sodium oxybate 6 g/night, or placebo. The primary outcome measure, viewed
by both U.S. and E.U. regulatory authorities as a clinically meaningful
endpoint, was the proportion of patients who achieved at least 30 percent
reduction in pain from baseline to endpoint based on the Pain Visual
Analog Scale (VAS). Data from the Fibromyalgia Impact Questionnaire (FIQ)
are considered equally relevant as Pain VAS data in the E.U. FIQ data are
considered supportive data by U.S. regulators.

In the top-line results, significantly more patients treated with sodium
oxybate achieved 30 percent or greater improvement in their pain compared
to patients treated with placebo. Of those patients receiving sodium
oxybate treatment, 35% of patients on 4.5 g/night and 35% of patients on
6 g/night reported this level of pain relief on the pain VAS, compared
with 20% of patients on placebo. These results were highly statistically
significant.

Patients' physical functioning and ability to perform daily tasks, as
measured by the FIQ, were highly statistically significantly different
from placebo for the 4.5 g/night dose and for the 6 g/night dose. Sodium
oxybate-treated patients also reported highly statistically significant
improvement in fatigue, another common symptom of fibromyalgia.

The most common adverse events (greater than or equal to five percent and
at least twice the rate of placebo) were nausea, dizziness, vomiting,
insomnia, anxiety, somnolence, fatigue, muscle spasms, and peripheral
oedema. Sodium oxybate was generally well tolerated, with the majority of
adverse events reported being mild to moderate in nature.

"These results from our second Phase III trial, confirming the positive
results of our first Phase III study, are an exciting milestone for Jazz
Pharmaceuticals," said Bruce Cozadd, Chairman and Chief Executive Officer
of Jazz Pharmaceuticals. "I'd like to thank the investigators, patients,
and Jazz Pharmaceuticals employees who helped us complete this trial."

"UCB is committed to improving the lives of people living with severe CNS
diseases," said Iris Loew-Friedrich, Chief Medical Officer of UCB. "The
positive results of the two Phase III trials are encouraging and suggest
that subject to regulatory approval, this may offer a new treatment
option for people with fibromyalgia."

Only preliminary top-line efficacy and safety data are available at this
time. Further analyses are planned, including analyses of additional
secondary endpoints. Jazz Pharmaceuticals anticipates submitting a New
Drug Application for sodium oxybate to the U.S. Food and Drug
Administration (FDA) by the end of 2009. UCB will consult with the
European Medicines Agency (EMEA) to define the path forward. UCB has the
exclusive marketing and distribution rights to sodium oxybate for
fibromyalgia in Europe and some other countries outside North America and
will manage registrations accordingly.

For further information

Contacts at Jazz Pharmaceuticals:
Willie Quinn, Executive Director, Corporate Development of Jazz
Pharmaceuticals, Inc.
+1-650-496-2800 - investorinfo@jazzpharmaceuticals.com

BCC Partners on behalf of Jazz Pharmaceuticals, Inc.
Karen L. Bergman, 650-575-1509
Michelle Corral, 415-794-8662

Contacts at UCB:
Antje Witte, Corporate Communications & Investor Relations, UCB
T +32.2.559.9414, antje.witte@ucb.com

Richard Simpson, Investor Relations, UCB
T +32.2.559.9494, Richard.Simpson@ucb.com

Nancy Nackaerts, External Communications, UCB
T +32.2.559.9264, nancy.nackaerts@ucb.com

Notes to the editor

About Sodium Oxybate

Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an
endogenous neurotransmitter and metabolite of GABA. While the precise
mechanism of action is unknown, the effects may be mediated in part
through interaction with GABA(B) and GHB receptors. Sodium oxybate is the
active ingredient in XYREM(R), approved by the FDA and marketed by Jazz
Pharmaceuticals in the U.S. for the treatment of excessive daytime
sleepiness and cataplexy (the sudden loss of muscle tone) in adult
patients with narcolepsy. The American Academy of Sleep Medicine
recommends sodium oxybate as a standard of care for the FDA-approved
indications. UCB markets XYREM(R) (sodium oxybate oral solution) in
Europe, where it is approved by the EMEA for the treatment of narcolepsy
with cataplexy in adult patients under a license from Jazz
Pharmaceuticals. Most commonly reported adverse drug reactions in
narcolepsy patients are dizziness, nausea and headaches. Sodium oxybate
has the potential to induce respiratory depression and neuropsychiatric
events. Sodium oxybate has not been evaluated by regulators for the
treatment of fibromyalgia and is not approved for this use.

About Fibromyalgia

Fibromyalgia, a chronic condition characterized by widespread pain,
affects 0.5% - 5% of adults worldwide. Fibromyalgia is believed to be a
central nervous system condition, resulting from neurological changes in
how the brain perceives and responds to pain. In addition to pain, the
main symptoms are fatigue, disturbed sleep and morning stiffness. The
exact causes of fibromyalgia are unknown. It may be triggered by physical
trauma, emotional stress, chronic pain or infection. Genetics,
neurochemicals that affect pain modulation, neurohormones and sleep
physiology abnormalities are thought to play a role. Research also has
suggested a relationship between sleep and pain. Fibromyalgia patients
experience a high prevalence of sleep problems, including a reduction in
non-restorative or deep sleep.

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals (NASDAQ: JAZZ) is a specialty pharmaceutical company
that identifies, develops and commercializes innovative treatments for
important, underserved markets in neurology and psychiatry. For further
information see www.JazzPharmaceuticals.com.

About UCB

UCB (Brussels, Belgium, www.ucb.com) is a biopharmaceutical company
dedicated to the research, development and commercialization of
innovative medicines with a focus on central nervous system and
immunology disorders. Employing around 10,000 people in over 40
countries, UCB achieved revenue of EUR 3.6 billion in 2008. UCB is listed
on Euronext Brussels (symbol: UCB).

Jazz Pharmaceuticals "Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995

This press release contains forward-looking statements related to the
development and commercial potential of Jazz Pharmaceuticals' sodium
oxybate (JZP-6) product candidate for the treatment of fibromyalgia,
including further analysis of the study results and the anticipated
timing for the submission of a New Drug Application to the FDA. These
forward-looking statements are based on the company's current
expectations and inherently 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 the outcome of further analysis of
the data from the study, risks related to the company's financial
position and default on its senior debt, and risks that regulatory
filings may not be made, or may be delayed, and that the sodium oxybate
(JZP-6) product candidate may not be approved for marketing for the
treatment of fibromyalgia by regulatory authorities. These and other risk
factors are discussed under "Risk Factors" in the Quarterly Report on
Form 10-Q for the quarter ended March 31, 2009 filed by Jazz
Pharmaceuticals with the Securities and Exchange Commission on May 7,
2009. 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.

UCB Forward-looking Statement

This press release contains forward-looking statements based on current
plans, estimates and beliefs of management. Such statements are subject
to risks and uncertainties that may cause actual results to be materially
different from those that may be implied by such forward-looking
statements contained in this press release. Important factors that could
result in such differences include: changes in general economic, business
and competitive conditions, effects of future judicial decisions, changes
in regulation, exchange rate fluctuations and hiring and retention of
employees.

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