PALO ALTO, Calif., June 11 Jazz Pharmaceuticals,Inc. (Nasdaq: JAZZ) today announced that timelines for two of its developmentprograms have been delayed. In addition, the company will reduce its emphasison early-stage research and development activities and implement a workforcereduction. Jazz Pharmaceuticals' sales and marketing activities will not beaffected by these changes.
Clinical development will continue as previously disclosed for JZP-6, forwhich top-line results from the first of two Phase III clinical trials for thetreatment of fibromyalgia syndrome are expected by the end of 2008. JazzPharmaceuticals recently announced completion of enrollment in this trial.Submission of a New Drug Application for JZP-6 is targeted for the fourthquarter of 2009. As previously disclosed, the ongoing Phase II trial ofJZP-8, in development for the treatment of recurrent acute repetitiveseizures, is also expected to be completed during 2008.
The company plans to complete additional pre-clinical activities prior toinitiation of the Phase III program for JZP-7, its product candidate for thetreatment of restless legs syndrome. As a result, the start of the Phase IIIprogram for JZP-7 will be delayed. The Phase II clinical development ofJZP-4, Jazz Pharmaceuticals' product candidate for the chronic treatment ofepilepsy and bipolar disorder, will be delayed to allow further formulationdevelopment work to be completed. The Phase II trial for JZP-4 and the PhaseIII trials for JZP-7 and JZP-8 will proceed in 2009 with additional financingor development partners for the company.
"Reducing our overall R&D spending commitments and streamlining ouradministrative operations gives us additional flexibility in our requirementsfor future financing and we believe will shorten our timeline to reachprofitability," said Dr. Samuel Saks, the Chief Executive Officer of JazzPharmaceuticals. "We are actively seeking partners for several of ourdevelopment programs. We have been pleased with the level of interest frompotential partners and look forward to completing one or more developmentpartnerships to help us bring these important therapies to the market asquickly as possible."
In connection with these strategic decisions, Jazz Pharmaceuticals willreduce its workforce by 33 employees (8 percent), primarily in research anddevelopment and administrative areas. The company expects to record a chargeof approximately $0.5 million related to the workforce reduction in the secondquarter of 2008.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company focused onidentifying, developing and commercializing innovative products to meet unmetmedical needs in neurology and psychiatry. For further information seehttp://www.JazzPharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Actof 1995
This press release contains forward-looking statements, including, but notlimited to, statements related to the continued development of JazzPharmaceuticals' development product candidates, the timing of clinical studyactivities, the completion or results of potential development partnershipsand the estimated charge related to the workforce reduction. These forward-looking statements are based on the company's current expectations andinherently involve significant risks and uncertainties. Jazz Pharmaceuticals'actual results and the timing of events could differ materially from thoseanticipated in such forward looking statements as a result of these risks anduncertainties, which include, without limitation, risks related to thedevelopment of Jazz Pharmaceuticals' product candidates, including the riskthat study or clinical trial results may require Jazz Pharmaceuticals todiscontinue its development; risks related to the uncertain and time-consumingregulatory approval process; ri