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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

December 2007, Jazz Pharmaceuticals dosed the first patient in an ongoing Phase II clinical trial of JZP-8. Assuming successful results from the Phase II trial, Jazz Pharmaceuticals expects to initiate a Phase III clinical development program for JZP-8 in the first half of 2009.

Jazz Pharmaceuticals' product candidate for once-daily treatment of epilepsy and bipolar disorder, JZP-4, incorporates a new chemical entity that inhibits both sodium and calcium channels in vitro and has shown efficacy in animal models. Two proof-of-concept clinical studies in healthy volunteers and patients demonstrated activity in well-validated epilepsy models. Jazz Pharmaceuticals plans to begin enrolling subjects in a Phase II trial of JZP-4 for the treatment of epilepsy during the third quarter of 2008.

Jazz Pharmaceuticals also disclosed three additional early-stage programs: a solid oral dosage form of sodium oxybate; a new chemical entity that is a structural analog of valproic acid for the treatment of epilepsy and bipolar disorder; and a new chemical entity that is a triple reuptake inhibitor for major depressive disorder. Both of the new chemical entities are in early feasibility studies and Jazz Pharmaceuticals has established clear targets to advance them into full development.

Financial Updates

Jazz Pharmaceuticals provided guidance forecasting selling, general and administrative expenses during 2008 to be in the range of $130 million to $140 million, reflecting the expanded sales force, launch activities related to LUVOX CR and costs associated with being a public company. Research and development spending during 2008 is expected to be in the range of $60 million to $70 million.

Jazz Pharmaceuticals also announced that it has amended its agreement with Solvay Pharmaceuticals, Inc., to defer the payment of milestones triggered by the approval and launch of LUVOX CR.

A webcast of Jazz Pharmaceuticals' Investor Day is available on the i
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SOURCE Jazz Pharmaceuticals, Inc.
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