Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary...(patients and Jazz Pharmaceuticals employ...),Health

"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

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