-----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, R7vzbtWm17iR+R1qTObnK7UrIlY1lbnR2O3Uhn2sw5KQOM1W5hgQx75jnsmShFge sJxXIm4hytjYmK1vehLwfA== 0001181431-06-005803.txt : 20060126 0001181431-06-005803.hdr.sgml : 20060126 20060126161141 ACCESSION NUMBER: 0001181431-06-005803 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060126 ITEM INFORMATION: Other Events FILED AS OF DATE: 20060126 DATE AS OF CHANGE: 20060126 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: 06553744 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 rrd105057.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)               January 20, 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 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. Description

99.1 Press Release dated January 20, 2006

EX-99. 2 rrd105057_11204.htm Draft 4

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

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. Inspire has significant technical and scientific expertise in the therapy areas of ophthalmology and respiratory and is a leader in the field of P2 receptors which are important drug targets in various therapeutic areas, including ophthalmology, respiratory disease and cardiovascular disease. Inspire's U.S. specialty sales force promotes ElestatÒ (epinastine HCl ophthalmic solution) 0.05% and RestasisÒ (cyclosporine ophthalmic emulsion) 0.05%, ophthalmology products developed by Inspire's partner, Allergan, Inc. Elestat and Restasis are trademarks owned by Allergan, Inc.

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.

# # #

-----END PRIVACY-ENHANCED MESSAGE-----