Jazz Pharmaceuticals, Inc announced that timelines for two of its development programmes have been delayed. In addition, the company will reduce its emphasis on early-stage research and development activities and implement a workforce reduction. Jazz Pharmaceuticals' sales and marketing activities will not be affected by these changes.
Clinical development will continue as previously disclosed for JZP-6, for which top-line results from the first of two phase III clinical trials for the treatment of fibromyalgia syndrome are expected by the end of 2008. Jazz Pharmaceuticals recently announced completion of enrolment in this trial. Submission of a New Drug Application for JZP-6 is targeted for the fourth quarter of 2009. As previously disclosed, the ongoing phase II trial of JZP-8, in development for the treatment of recurrent acute repetitive seizures, is also expected to be completed during 2008.
The company plans to complete additional pre-clinical activities prior to initiation of the phase III program for JZP-7, its product candidate for the treatment of restless legs syndrome. As a result, the start of the phase III program for JZP-7 will be delayed. The phase II clinical development of JZP-4, Jazz Pharmaceuticals' product candidate for the chronic treatment of epilepsy and bipolar disorder, will be delayed to allow further formulation development work to be completed. The phase II trial for JZP-4 and the phase III trials for JZP-7 and JZP-8 will proceed in 2009 with additional financing or development partners for the company.
"Reducing our overall R&D spending commitments and streamlining our administrative operations gives us additional flexibility in our requirements for future financing and we believe will shorten our timeline to reach profitability," said Dr Samuel Saks, the chief executive officer of Jazz Pharmaceuticals. "We are actively seeking partners for several of our development programmes. We have been pleased with the level of interest from potential partners and look forward to completing one or more development partnerships to help us bring these important therapies to the market as quickly as possible".
In connection with these strategic decisions, Jazz Pharmaceuticals will reduce its workforce by 33 employees, primarily in research and development and administrative areas. The company expects to record a charge of approximately $0.5 million related to the workforce reduction in the second quarter of 2008.