-----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, LDb6nC4G6Wpbc8wExYfQyfem2lT0yy+NEy4v/pNd0zJakvTDEKIXG6Zzn+t1Jqdv 93fjx5+EOW6XWVLtLKgqTw== 0001181431-08-026652.txt : 20080425 0001181431-08-026652.hdr.sgml : 20080425 20080425150512 ACCESSION NUMBER: 0001181431-08-026652 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080425 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080425 DATE AS OF CHANGE: 20080425 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 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31577 FILM NUMBER: 08777410 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 rrd204017.htm _

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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)              April 23, 2008

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 April 23, 2008, Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) issued a press release, attached to and made part of this report, announcing it will discontinue development of Epinastine nasal spray.

Item 9.01     Financial Statements and Exhibits.

(d)    Exhibits

No.              Description

99.1             Press Release dated April 23, 2008

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: April 25, 2008

EXHIBIT INDEX

 

No.              Description

99.1             Press Release dated April 23, 2008

EX-99.1 2 rrd204017_24157.htm EXHIBIT 99.1 _

For Immediate Release

Investor Contact:
Inspire Pharmaceuticals, Inc.

Jenny Kobin
VP, Investor Relations and Corporate Communications
(919) 941-9777, Extension 219

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

INSPIRE TO DISCONTINUE DEVELOPMENT OF EPINASTINE NASAL SPRAY

DURHAM, NC - April 23, 2008 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that its Phase 3 trial with epinastine nasal spray for the treatment of seasonal allergic rhinitis (SAR) did not meet its primary endpoint.

"Our analysis of the overall data in this program and the current competitive environment in allergic rhinitis indicate that epinastine nasal spray does not show potential to meet our desired product profile in the United States," stated Christy L. Shaffer, Ph.D., President and CEO of Inspire. "We do not plan to allocate any future resources to this program and will focus on our commercial products and progressing our high-priority development programs."

The 14-day, randomized, double-blind trial in 798 patients evaluated two concentrations of epinastine (0.10% and 0.15%) at two spray volumes compared to placebo in patients with documented SAR during mountain cedar season in south central Texas. The epinastine treatment groups did not achieve statistical significance compared to placebo for the primary efficacy endpoint of average change from baseline for the reflective Total Nasal Symptom Score (TNSS), defined as the sum of scores for runny nose, itchy nose and sneezing. The drug was well-tolerated and there were no safety concerns in the trial.

In 2006, Inspire acquired certain exclusive rights from Boehringer Ingelheim International GmbH to develop and market epinastine nasal spray in the United States and Canada for the treatment of rhinitis.

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 employs a U.S. sales force for the promotion of AzaSite® (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat® (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis® (cyclosporine ophthalmic emulsion) 0.05% for dry eye. Inspire is focused on the therapeutic areas of ophthalmology and respiratory, and is developing products for dry eye, cystic fibrosis and glaucoma. Elestat and Restasis are registered trademarks owned by Allergan, Inc. AzaSite is a registered trademark owned by InSite Vision Incorporated. 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. Specifically, no assurances can be made that Inspire will not need to, or otherwise determine to, allocate any future resources to the epinastine nasal spray program. Furthermore, no assurances can be made regarding Inspire's ability to focus on its commercial products and progress its high-priority development programs, or the success of its commercialization efforts or development programs even if able to focus its efforts. 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 commercialization of AzaSite, Restasis and Elestat, intellectual property rights, adverse litigation developments, adverse developments in th e 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 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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