UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
August 20, 2010
Date of Report (Date of earliest event reported)
JAZZ PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
| Delaware | 001-33500 | 05-0563787 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File No.) |
(IRS Employer Identification No.) |
3180 Porter Drive, Palo Alto, California 94304
(Address of principal executive offices, including zip code)
(650) 496-3777
(Registrant’s 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. |
On August 20, 2010, Jazz Pharmaceuticals, Inc. issued a press release titled “Jazz Pharmaceuticals Provides Update on FDA Advisory Committee Meeting For JZP-6 (Sodium Oxybate) in Fibromyalgia.” A copy of the press release is furnished as Exhibit 99.1 to this report.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit Number |
Description | |
| 99.1 | Press Release dated August 20, 2010 | |
SIGNATURES
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/ BRUCE C. COZADD | |
| Bruce C. Cozadd | ||
| Chairman and Chief Executive Officer | ||
Date: August 23, 2010
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press Release dated August 20, 2010 | |
Exhibit 99.1
JAZZ PHARMACEUTICALS PROVIDES UPDATE ON FDA ADVISORY
COMMITTEE MEETING FOR JZP-6 (SODIUM OXYBATE) IN FIBROMYALGIA
— Company to Hold Investor Teleconference on Monday, August 23 —
PALO ALTO, Calif., August 20, 2010 — Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the Joint Advisory Committee of the U.S. Food and Drug Administration (FDA), including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of fibromyalgia with the currently proposed Risk Evaluation Mitigation Strategy (REMS).
“While we are disappointed with the recommendation of the Joint Advisory Committee, we plan to work closely with FDA on the continuing review of our new drug application (NDA),” said Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, Inc. “We will carefully consider the input of the Committee as we seek to address the needs of fibromyalgia patients for new treatment options in a safe and responsible way.”
Company to Host Teleconference on Monday, August 23
Jazz Pharmaceuticals will hold a teleconference and webcast for the investment community at 8:30 a.m. EDT (5:30 a.m. PDT) on Monday, August 23 to discuss the outcome of the FDA advisory committee meeting. Investors may participate in the conference call by dialing 866.713.8566 in the U.S., or 617.597.5325 outside the U.S., and entering 35059911.
A live webcast of the teleconference may be accessed from the Investors section of the 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 to listen to the webcast.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals (Nasdaq: JAZZ) is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. For further information see www.jazzpharmaceuticals.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including statements related to future regulatory matters. These forward-looking statements are based on the company’s current expectations and 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, risks related to the uncertain and time-consuming regulatory approval process for JZP-6 and those risks detailed from time-to-time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals’ Securities and Exchange Commission filings and reports, including in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on August 11, 2010. 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.
Contact
Ami Knoefler
Executive Director, Investor Relations &
Corporate Communications
Jazz Pharmaceuticals, Inc.
investorinfo@jazzpharmaceuticals.com
650-496-2947