-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, IkxXx8/d2mYdlGTw0frdLSmpSRqUWPXuPbmHlk8boI6bNfoEZ4F/c0aHRea1zGcp DG4SagEgzB1sLpaBs6EaPA== 0001181431-06-057949.txt : 20061012 0001181431-06-057949.hdr.sgml : 20061012 20061012155223 ACCESSION NUMBER: 0001181431-06-057949 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20061012 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061012 DATE AS OF CHANGE: 20061012 FILER: COMPANY DATA: COMPANY CONFORMED NAME: INSPIRE PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001040416 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043209022 STATE OF INCORPORATION: DE FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31577 FILM NUMBER: 061142109 BUSINESS ADDRESS: STREET 1: 4222 EMPEROR BLVD STE 200 CITY: DURHAM STATE: NC ZIP: 27703-8466 BUSINESS PHONE: 9199419777 MAIL ADDRESS: STREET 1: 4222 EMPEROR BLVD STREET 2: STE 200 CITY: DURHAM STATE: NC ZIP: 27703-8466 8-K 1 rrd133174.htm 6YBQ02!.DOC

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of report (Date of earliest event reported)               October 10, 2006

INSPIRE PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)

Delaware                                    000-31135                            04-3209022
(State or Other Jurisdiction               (Commission                           (IRS Employer
       of Incorporation)                           File Number)                          Identification No.)

4222 Emperor Boulevard, Suite 200, Durham, North Carolina            27703-8466
(Address of Principal Executive Offices)                                                     (Zip Code)

Registrant's telephone number, including area code          (919) 941-9777

_____________________________________________
(Former Name or Former Address, if Changed Since Last Report)

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.               Description

99.1              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.             Description

99.1            Press Release dated October 10, 2006

EX-99.1 2 rrd133174_16323.htm PRESS RELEASE _

For Immediate Release

Investor Contact:
Inspire Pharmaceuticals, Inc.
Jenny Kobin,
Senior Director, Investor Relations
(919) 941-9777, Extension 219

Media Contact:
BMC Communications
Dan Budwick
(212) 477-9007, Extension 14

 

 

   

INSPIRE BEGINS PHASE 2 CLINICAL PROGRAM
OF EPINASTINE FOR SEASONAL ALLERGIC RHINITIS

- 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

Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. The research and development programs of Inspire are driven by extensive scientific experience in the therapeutic areas of ophthalmology and respiratory/allergy, and supported by expertise in the field of P2 receptors. Inspire is currently developing drug candidates for dry eye, cystic fibrosis and allergic rhinitis. Inspire's U.S. specialty sales force promotes Elestat® (epinastine HCI ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis® (cyclosporine ophthalmic emulsion) 0.05% for dry eye, ophthalmology products developed by Allergan, Inc. Elestat and Restasis are trademarks owned by Allergan. For more information, visit www.inspirepharm.com.

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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