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Jazz Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2007 Financial Results

in part by lower legal fees.

Jazz Pharmaceuticals' unrestricted cash, cash equivalents and marketable securities balance as of December 31, 2007 was $102.9 million. Net operating cash used during the year ended December 31, 2007 was $81.1 million.

Recent Highlights

-- On January 31, 2008, Jazz Pharmaceuticals announced that the U.S. Food

and Drug Administration (FDA) had accepted for review the submission of

the response by Solvay Pharmaceuticals, Inc. to the FDA approvable

letter for LUVOX CR. The FDA notified Solvay Pharmaceuticals that it

considered this a complete, class 1 response and the PDUFA action date

is February 29, 2008. In an approvable letter received on

December 21, 2007, the FDA had requested additional information

concerning a chemistry, manufacturing and control (CMC) issue. The

approvable letter did not raise any questions related to safety or

efficacy of LUVOX CR and included the FDA's proposed labeling. Jazz

Pharmaceuticals and Solvay Pharmaceuticals believe that the response

submitted to the FDA on December 28, 2007 fully addressed that CMC


-- Jazz Pharmaceuticals has completed the expansion of its sales force,

and now has a total of approximately 200 field sales personnel,

including sales management and sales representatives. These

individuals are currently in their assigned sales territories promoting


-- In early January 2008, Jazz Pharmaceuticals announced that it had

received orphan drug designation from the FDA for its JZP-8 product

candidate for the treatment of recurrent acute repetitive seizures.

JZP-8 is a novel drug delivery formulation incorporating clonazepam, a

widely prescribed benzodiazepine. The product candidate is designed to

be a fast-acting intranasal spray for the treatment of re

SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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