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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 10, 2006, Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) issued a press release, attached to and made part of this report, announcing that an investigational new drug application for epinastine nasal spray has been filed with the U.S. Food and Drug Administration and is in effect, having passed the 30-day review period.
Item 9.01 Financial Statements and Exhibits.
Exhibits
No.
Description99.1 Press Release dated October 10, 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: October 12, 2006
EXHIBIT INDEX
No.
DescriptionFor Immediate Release
Investor Contact: Media Contact:
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- Epinastine Nasal Spray IND Filed and in Effect with FDA -
DURHAM, NC -- October 10, 2006 -- Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that an investigational new drug application (IND) for epinastine nasal spray has been filed with the U.S. Food and Drug Administration (FDA) and is in effect, having passed the 30-day review period. Inspire previously acquired certain exclusive rights from Boehringer Ingelheim to develop and market an intranasal dosage form of epinastine in the United States and Canada for the treatment or prevention of rhinitis.
Inspire has begun Phase 2 clinical testing in patients with seasonal allergic rhinitis, based on the existing data package on epinastine, including Phase 1 safety data. The Phase 2 program will include clinical and toxicology studies to determine the optimal formulation and dose. The initial clinical trial compares several formulations and concentrations over one day.
Donald J. Kellerman, Pharm.D., Inspire's Senior Vice President, Development, stated, "Our experience with epinastine for ocular allergies, known as Elestat®, enables us to combine our scientific knowledge of the molecule with its well-established pharmacological and tolerability profile. Also, we will be leveraging our expertise in the development and commercialization of allergy products with a proven molecule in a straightforward regulatory approval path."
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. Inspire cannot guarantee the outcome or timing of the clinical or toxicology studies for epinastine for allergic rhin itis. A significant amount of work will be required to advance epinastine nasal spray through clinical testing, including satisfactory completion of additional clinical trials (including Phase 3 clinical trials) and additional toxicology studies. Even if the future development program for epinastine nasal spray is successful, Inspire cannot predict when, or if, the FDA or other regulatory authorities will approve epinastine nasal spray for allergic rhinitis. 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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