indicated that a future New Drug Application filing for this product
candidate could be eligible to receive priority review. The company
plans to initiate a Phase II clinical trial in the fourth quarter of
-- Interim data have been obtained from two single dose studies, one in
healthy volunteers and one in epilepsy patients, of JZP-4, a product
candidate for the treatment of partial epilepsy and bipolar disorder.
The data from both of these studies indicate biological activity in
human epilepsy models. A single dose study of a controlled-release
formulation of JZP-4 is underway, and is expected to complete in the
fourth quarter of 2007. Jazz Pharmaceuticals plans to initiate
Phase II clinical trial activities for JZP-4 by the end of 2007.
-- A second pharmacokinetic study of JZP-7, a product candidate for the
treatment of restless legs syndrome, was initiated in the third quarter
of 2007, and Jazz Pharmaceuticals expects top line results from that
study in the second quarter of 2008.
-- In August 2007, the U.S. Patent and Trademark Office (USPTO) awarded
Jazz Pharmaceuticals a new U.S. patent (No. 7,262,219) titled
"Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate
Salt for the Treatment of Narcolepsy." This Xyrem patent is now listed
in the FDA's Orange Book.
Jazz Pharmaceuticals will host an investor conference call and live
audio webcast to discuss its quarterly results on November 6, 2007 at 5:00
p.m. Eastern Time/2:00 p.m. Pacific Time. The live webcast and press
release 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 m
|SOURCE Jazz Pharmaceuticals, Inc.|
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