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UNITED STATES FORM 8-K CURRENT REPORT Date of report (Date of earliest event reported)
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
INSPIRE PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware 000-31135 04-3209022
4222 Emperor Boulevard, Suite 200, Durham, North Carolina 27703-8466
Registrant's telephone number, including area code
(919) 941-9777_____________________________________________
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 (see General Instruction A.2. below):
[ ] 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 October 5, 2006, Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) issued a press release, attached to and made part of this report, announcing that they met with the U.S. Food and Drug Administration (FDA) in late September 2006 to continue ongoing discussions related to Inspire's dry eye clinical program for Prolacria™.
Item 9.01 Financial Statements and Exhibits.
Exhibits
No.
Description99.1 Press Release dated October 5, 2006
SIGNATURE
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.
Inspire Pharmaceuticals, Inc.
By: /s/ Joseph M. Spagnardi
Joseph M. Spagnardi,
Senior Vice President, General Counsel
and Secretary
Dated: October 5, 2006
EXHIBIT INDEX
No.
DescriptionFor Immediate Release
Investor Contact: Media Contact:
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DURHAM, NC -- October 5, 2006 -- Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) met with the U.S. Food and Drug Administration (FDA) in late September 2006 to continue ongoing discussions related to Inspire's dry eye clinical program for Prolacria™ (the proposed U.S. trade name for diquafosol tetrasodium ophthalmic solution 2%).
Based on this meeting, Inspire plans to provide the FDA with additional information to facilitate ongoing discussions related to Prolacria. Inspire expects to meet with the FDA again following the FDA's review of this information.
Christy L. Shaffer, Ph.D., President and CEO of Inspire, stated, "We believe our discussions with the FDA have been constructive but the overall program remains challenging and the outcome is uncertain."
About Inspire
Forward-Looking Statements
The forward-looking statements in this news release relating to management's expectations and beliefs are based on preliminary information and management assumptions. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, the seasonality of Elestat, intellectual property rights, adverse litigation developments, adverse developments in the U.S. Securities and Exchange Commission (SEC) investigation, competitive products, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, delays in manufacturing, funding, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration. Although Inspire intends to provide additional information regarding Prolacria to the FDA, there is no assuran ce that such additional information will be sufficient for approval of Prolacria by the FDA. Inspire can make no assurance on the outcome or timing of future discussions with the FDA regarding Prolacria, including the likelihood that Inspire will continue to move forward to seek regulatory approval of Prolacria. It may be necessary for Inspire to conduct additional clinical trials of Prolacria and there is no guarantee that any additional clinical trials will be successful or that the FDA will approve Prolacria. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the SEC. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof.
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