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Jazz Pharmaceuticals, Inc. Announces LUVOX CR Launch Plans and Reports Development Pipeline Progress at Investor Day Presentation
Date:3/13/2008

hase III clinical trial of JZP-6, with clinical sites in the U.S., Canada, Europe and South America, is approximately 30 percent enrolled. With successful results from these trials, Jazz Pharmaceuticals expects to submit a New Drug Application (NDA) to the FDA by the end of 2009. Fibromyalgia syndrome affects 6 to 12 million patients in the U.S., many of whom are treated with a polypharmacy approach and continue to look for new treatment options.

"In 2007, we made extraordinary progress in our later-stage development programs, which we have carefully selected to address significant unmet neurological and psychiatric medical needs in fibromyalgia syndrome, restless legs syndrome, recurrent acute repetitive seizures, epilepsy and bipolar disorder," said Dr. Saks. "These clinical programs are on track with our portfolio-building objectives, and we continue to add early-stage projects to expand our pipeline."

Jazz Pharmaceuticals announced that JZP-7, a proprietary transdermal gel formulation of ropinirole, is designed to provide an effective, once-a-day treatment of moderate to severe restless legs syndrome. JZP-7 has been successfully evaluated in one pharmacokinetic (PK) study, and a second PK study is near completion. Available results from both studies demonstrate that the product is well tolerated. Jazz Pharmaceuticals is currently planning to initiate a Phase III clinical trial in the fourth quarter of 2008. Restless legs syndrome affects up to 10 percent of the U.S. population.

Jazz Pharmaceuticals' product candidate for the treatment of recurrent acute repetitive seizures in patients with epilepsy, JZP-8, is designed to be a fast-acting intranasal spray providing a socially-acceptable treatment option. As previously announced, Jazz Pharmaceuticals has received orphan drug designation from the FDA for JZP-8. This novel formulation incorporates clonazepam, a widely prescribed benzodiazepine indicated for the chronic treatment of epilepsy. In
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SOURCE Jazz Pharmaceuticals, Inc.
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