SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
December 20, 2007
Date of Report (Date of earliest event reported)
JAZZ PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
(State or Other
|(Commission File No.)|| |
3180 Porter Drive, Palo Alto, California 94304
(Address of principal executive offices, including zip code)
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|¨||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
|Item 8.01||Other Events.|
The New Drug Application for Luvox® (immediate release tablets) was approved by the Food and Drug Administration on December 20, 2007. Jazz Pharmaceuticals, Inc. does not currently plan to market the product. The approval included post-marketing commitments to provide to the FDA the data from ongoing toxicology studies of the fluvoxamine drug substance. The cost of fulfilling this commitment is not expected to be material.
|Item 9.01||Financial Statements and Exhibits.|
|99.1||Press Release dated December 21, 2007|
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|JAZZ PHARMACEUTICALS, INC.|
|By:||/s/ Carol A. Gamble|
Carol A. Gamble
Senior Vice President, General Counsel
and Corporate Secretary
Date: December 21, 2007
|99.1||Press Release dated December 21, 2007|
FDA ISSUES APPROVABLE LETTER FOR LUVOX® CR (FLUVOXAMINE MALEATE)
EXTENDED-RELEASE CAPSULES FOR THE TREATMENT OF SOCIAL ANXIETY
DISORDER (SAD) AND OBSESSIVE COMPULSIVE DISORDER (OCD)
PALO ALTO, Calif. Dec. 21, 2007Today, Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for Once-A-Day LUVOX® CR (fluvoxamine maleate) Extended-Release Capsules, for which Jazz Pharmaceuticals and Solvay Pharmaceuticals, Inc. are seeking marketing approval for the treatment of two anxiety disorders, social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).
The FDA requested information related to the companies response concerning the previously disclosed CMC issue. The companies are seeking clarification from FDA and look forward to working with FDA to resolve this as quickly as possible. The approvable letter did not raise any questions related to safety or efficacy of LUVOX® CR. The approvable letter included the FDAs proposed labeling.
Separately, the FDA approved LUVOX® (fluvoxamine maleate) for the treatment of OCD on December 20, 2007.
Jazz Pharmaceuticals will host an investor conference call and live audio webcast to discuss this corporate update on December 24, 2007 at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time. The live webcast and press release may be accessed on Jazz Pharmaceuticals website at www.JazzPharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. An archived version of the webcast will be available through January 7, 2008. Investors may participate in the conference call by dialing 1-866-383-8009 in the U.S., or 1-617-597-5342 outside the U.S., and entering passcode 31811188. A replay of this call will be available until January 7, 2008 at 1-888-286-8010 (U.S.), or 1-617-801-6888 (international), using the passcode 32600407.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical
needs in neurology and psychiatry. For further information, please visit www.JazzPharmaceuticals.com.
LUVOX is a registered trademark of Solvay Pharmaceuticals, Inc.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the implications of the approvable letter for LUVOX CR. These forward-looking statements inherently involve significant risks and uncertainties. Jazz Pharmaceuticals actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, whether or when LUVOX CR will be approved or launched. These and other risk factors are discussed under Risk Factors, in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on November 9, 2007. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
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Jazz Pharmaceuticals, Inc.
Jim Karrels, Executive Director, Finance