Jazz Pharmaceuticals and UCB Announce Positive Phase III Results for Sodium Oxybate (JZP-6) in Fi...(nd safety data have been reviewed at thi...),Health

Date:11/20/2008

nd safety data have been reviewed at this time. Further analyses will be undertaken to examine the full results, including secondary endpoints, in greater detail. The sodium oxybate Phase III clinical trial program also includes a second randomized, double blind, placebo-controlled study, which is continuing at sites in the U.S. and Europe. More than 90% of the subjects have been enrolled in this second Phase III trial. Jazz Pharmaceuticals anticipates submitting a New Drug Application for sodium oxybate to the U.S. Food and Drug Administration by the end of 2009. UCB anticipates filing in the EU shortly after. 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.

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 An archived version of the webcast will be available through December 4, 2008.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

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 ma
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SOURCE Jazz Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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