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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 January 20, 2006, Inspire Pharmaceuticals, Inc. issued a press release, attached to and made part of this report, announcing that it has discontinued two Phase 2 pilot clinical trials of denufosol tetrasodium intravitreal injection in patients with macular edema, and has no plans to conduct any further studies of denufosol for the treatment of retinal disease
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
No. Description
99.1 Press Release dated January 20, 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/ Christy L. Shaffer
Christy L. Shaffer,
President, and Chief Executive Officer
Dated: January 26, 2006
EXHIBIT INDEX
No.
Description99.1 Press Release dated January 20, 2006
For Immediate Release
Contacts: Inspire Pharmaceuticals, Inc. Jenny Kobin Senior Director, Investor Relations (919) 941-9777 Extension 219 |
|
INSPIRE DISCONTINUES RETINAL DISEASE DRUG DEVELOPMENT PROGRAM
DURHAM, NC -- January 20, 2006 -- Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that it has discontinued two Phase 2 pilot clinical trials of denufosol tetrasodium intravitreal injection (INS37217 Ophthalmic) in patients with macular edema and has no plans to conduct any further studies of denufosol for the treatment of retinal disease.
The two pilot trials of denufosol were initiated in the second and third quarters of 2005. The first trial was targeted to enroll 15 patients with persistent macular edema associated with uveitis. Data from this trial was reviewed following the treatment and evaluation of 12 patients. There were no significant safety or tolerability issues identified in the trial. The data did not demonstrate improvement in either reduction of retinal thickness or improvement in visual acuity. The second trial was targeted to enroll 15 patients with persistent macular edema following cataract surgery. No patients had yet enrolled in the second trial. Inspire has stopped enrollment in both trials, but will continue to follow the treated patients for safety for a period of one year, as specified in the protocol.
Christy L. Shaffer, Ph.D., President and CEO of Inspire, commented, "During our recent portfolio review process, we prioritized our research and development programs and decided to discontinue the retinal program so that we can apply our resources to programs with higher potential value. Our utilization of small pilot trials to explore potential new indications enables us to gather information quickly and make prudent development decisions efficiently, thereby minimizing the time and expense of drug development."
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. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the S ecurities and Exchange Commission. 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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