Preliminary Top Line Results of Phase III Trial Show SignificantDecreases in Pain and Fatigue and Improved Daily Function inFibromyalgia Patients

PALO ALTO, CA/USA and BRUSSELS, Belgium, November 20, 2008 at10:00 PM (CET) - press release, regulated information - JazzPharmaceuticals, Inc. (Nasdaq: JAZZ) and UCB (Euronext Brussels: UCB)announced today positive preliminary top-line results from the firstof two Phase III clinical trials of sodium oxybate (JZP-6) for thetreatment of fibromyalgia. The randomized, double-blind,placebo-controlled study achieved its key endpoints, demonstratingthat sodium oxybate significantly decreased pain and fatigue, andimproved daily function in patients with fibromyalgia.

"There is a significant unmet need in diagnosing and treatingmillions of patients with fibromyalgia. Potential new treatments thataddress the various symptoms can have a significant impact onpatients' quality of life," said I. Jon Russell, M.D., Ph.D., one ofthe study's lead investigators and Associate Professor of Medicine,Division of Clinical Immunology and Rheumatology, and Director,University Clinical Research Center, University of Texas HealthScience Center at San Antonio.

The 14-week placebo-controlled study included 548 adult patients withfibromyalgia randomized to one of three treatment arms: sodiumoxybate 4.5 g/night, sodium oxybate 6 g/night or placebo. The primaryoutcome measure, viewed by both U.S. and EU regulatory authorities asa clinically meaningful endpoint, was the proportion of patients whoachieved at least 30 percent reduction in pain from baseline toendpoint based on the Pain Visual Analog Scale (VAS). In the EU, itis also considered that the Fibromyalgia Impact Questionnaire (FIQ)data is equally relevant. FIQ data are considered supportive data byU.S. regulators.

In the top-line results, significantly more patients treated withsodium oxybate achieved 30 percent or greater improvement in theirpain compared with placebo. Of those patients receiving sodiumoxybate treatment, 46.2 percent of patients on 4.5 g/night and 39.3percent of patients on 6 g/night reported this level of pain relief(VAS), compared with 27.3 percent of patients on placebo. Theseresults were highly statistically significant.

Patients' physical functioning and ability to perform daily tasks, asmeasured by the FIQ, were significantly different from placebo forthe 4.5 g/night dose and approached significance for the 6 g/nightdose.

Patients receiving sodium oxybate also reported significantimprovement in fatigue, another common symptom of fibromyalgia, atboth active dosage levels.

Adverse events were similar to those seen in other clinical studiesof sodium oxybate. The most common adverse events (greater than orequal to 5 percent and occurring at twice the rate of placebo) wereheadache, nausea, dizziness, vomiting, diarrhea, anxiety, andsinusitis. Sodium oxybate was generally well tolerated, with themajority of adverse events reported being mild to moderate in nature.

"Achieving positive sodium oxybate data in fibromyalgia from thisPhase III clinical trial is an exciting milestone for JazzPharmaceuticals and it supports our commitment to improving care forpatients with serious psychiatric and neurological conditions," saidSamuel Saks, M.D., Chief Executive Officer of Jazz Pharmaceuticals.

"As UCB continues to focus on serious diseases of the central nervoussystem and immunology, we are delighted to partner with JazzPharmaceuticals in bringing new hope for patients with thisunder-treated condition", said Roch Doliveux, Chief Executive Officerof UCB.

Only primary efficacy and safety data have been reviewed at thistime. Further analyses will be undertaken to examine the fullresults, including secondary endpoints, in greater detail. The sodiumoxybate Phase III clinical trial program also includes a secondrandomized, double blind, placebo-controlled study, which iscontinuing at sites in the U.S. and Europe. More than 90 percent ofthe subjects have been enrolled in this second phase III trial. JazzPharmaceuticals anticipates submitting a New Drug Application forsodium oxybate to the U.S. Food and Drug Administration (FDA) by theend of 2009. UCB anticipates filing in the EU shortly after.

UCB markets Xyrem® (sodium oxybate oral solution) in Europe for thetreatment of narcolepsy under a license from Jazz Pharmaceuticals.UCB has the exclusive marketing and distribution rights to Xyrem® forfibromyalgia in Europe and some other countries outside NorthAmerica, and will manage registrations accordingly.

Investor Conference CallJazz Pharmaceuticals will host an investor conference call and liveaudio webcast to discuss the preliminary top-line results from thisclinical trial on November 20, 2008 commencing at 5:00 p.m. EasternTime/2:00 p.m. Pacific Time. The live webcast may be accessed on JazzPharmaceuticals' website at http://www.JazzPharmaceuticals.com.Please connect to the website prior to the start of the conferencecall to ensure adequate time for any software downloads that may benecessary. An archived version of the webcast will be availablethrough December 4, 2008. Investors may participate in the conferencecall by dialing 866-730-5765 in the U.S., or 857-350-1589 outside theU.S., and entering passcode 52336179. A replay of this call will beavailable until December 4, 2008 at 888-286-8010 or 617-801-6888(international), using the passcode 46982308.

About Sodium OxybateSodium oxybate is the sodium salt form of gamma-hydroxybutyrate, anendogenous neurotransmitter and metabolite of GABA. While the precisemechanism of action is unknown, the effects may be mediated in partthrough interaction with GABAB and GHB receptors. Sodium oxybate isthe active ingredient in Xyrem®, approved by the U.S. Food and DrugAdministration (FDA) for the treatment of excessive daytimesleepiness (EDS) and cataplexy (the sudden loss of muscle tone) inadult patients with narcolepsy. The American Academy of SleepMedicine recommends sodium oxybate as a standard of care for theFDA-approved indications. It is also approved by the European MedicalEvaluation Agency (EMEA) for the treatment of narcolepsy withcataplexy in adult patients. Most commonly reported adverse drugreactions in narcolepsy patients are dizziness, nausea andheadaches. Sodium oxybate has the potential to induce respiratorydepression and neuropsychiatric events. Sodium oxybate has not beenevaluated by regulators for the treatment of fibromyalgia and is notapproved for this use.

About FibromyalgiaFibromyalgia, a chronic condition characterized by widespread pain,affects 0.5% - 5% of adults worldwide. Fibromyalgia is believed to bea central nervous system condition, resulting from neurologicalchanges in how the brain perceives and responds to pain. In additionto pain, the main symptoms are fatigue, disturbed sleep and morningstiffness.

The exact causes of fibromyalgia are unknown. It may be triggered byphysical trauma, emotional stress, chronic pain or infection.Genetics, neurochemicals that affect pain modulation, neurohormonesand sleep physiology abnormalities are thought to play a role.Research also shows a suggested relationship between sleep and pain. Fibromyalgia patients experience a high prevalence of sleepproblems, including a reduction in non-restorative or deep sleep.

About Jazz Pharmaceuticals, IncJazz Pharmaceuticals is a specialty pharmaceutical company thatidentifies, develops and commercializes innovative treatments forimportant, underserved markets in neurology and psychiatry. TheCompany has an unwavering commitment to improving care for patientswith serious psychiatric and neurological conditions throughinnovative treatments and distinctive and valuable programs forpatients and physicians. For further information seehttp://www.JazzPharmaceuticals.com.

About UCBUCB, Brussels, Belgium (www.ucb-group.com) is a globalbiopharmaceutical company dedicated to the research, development andcommercialisation of innovative medicines focused on central nervoussystem and immunology disorders. Employing more than 10,000 people inover 40 countries, UCB achieved revenues of 3.6 billion euro in 2007.UCB is listed on Euronext Brussels (symbol: UCB).

Jazz Pharmaceuticals "Safe Harbor" Statement under the PrivateSecurities Litigation Reform Act of 1995This press release contains forward-looking statements related to thedevelopment of Jazz Pharmaceuticals' sodium oxybate (JZP-6) productcandidate for the treatment of fibromyalgia, including the submissionof a New Drug Application to the FDA. These forward-lookingstatements are based on the company's current expectations andinherently involve significant risks and uncertainties. JazzPharmaceuticals' actual results and the timing of events could differmaterially from those anticipated in such forward-looking statementsas a result of these risks and uncertainties, which include, withoutlimitation, the risk that clinical trial results may require JazzPharmaceuticals to discontinue development of the sodium oxybate(JZP-6) product candidate, risks related to Jazz Pharmaceuticals'ability to obtain additional funds sufficient to support itsoperations, risks related to Jazz Pharmaceuticals' reliance on thirdparties to conduct the clinical trials for its product candidates,including the second Phase III clinical trial of the sodium oxybate(JZP-6) product candidate, and risks that regulatory filings may notbe made, or may be delayed, and that the sodium oxybate (JZP-6)product candidate for the treatment of fibromyalgia may not beapproved for marketing by regulatory authorities. These and otherrisk factors are discussed under "Risk Factors" in the QuarterlyReport on Form 10-Q for the quarter ended September 30, 2008 filed byJazz Pharmaceuticals with the Securities and Exchange Commission onNovember 14, 2008. Jazz Pharmaceuticals undertakes no duty orobligation to update any forward-looking statements contained in thisrelease as a result of new information, future events or changes inits expectations.

Forward looking statementThis press release contains forward-looking statements based oncurrent plans, estimates and beliefs of management. Such statementsare subject to risks and uncertainties that may cause actual resultsto be materially different from those that may be implied by suchforward-looking statements contained in this press release. Importantfactors that could result in such differences include: changes ingeneral economic, business and competitive conditions, effects offuture judicial decisions, changes in regulation, exchange ratefluctuations and hiring and retention of employees.

Contacts at Jazz Pharmaceuticals

Jazz Pharmaceuticals BCC PartnersMatthew Fust, Chief Financial Officer Karen L. Bergman, +1-650-575-1509T +1-650-496-2800 or Michelle Corral, +1-415-794-8662investorinfo@jazzpharmaceuticals.com

Contacts at UCBAntje Witte, Corporate Communications & Investor Relations, UCBT +32.2.559.9414, Antje.witte@ucb-group.comMichael Tuck-Sherman, Investor Relations, UCBT +32.2.559.9712, Michael.Tuck-Sherman@ucb-group.com

For the pdf-version of this press release, please click on the linkbelow:

This announcement was originally distributed by Hugin. The issuer issolely responsible for the content of this announcement.

Copyright © Hugin AS 2008. All rights reserved.