-----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, S6uajRIbOXierUSgZWbFPSUQlimZjEiyOdviYSqfIFJWsgdE5Fpi7nWmi9gA/Z8x 2SxQF8V1Ha6N74J+rxwFxw== 0001181431-07-071963.txt : 20071129 0001181431-07-071963.hdr.sgml : 20071129 20071128174035 ACCESSION NUMBER: 0001181431-07-071963 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071128 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071129 DATE AS OF CHANGE: 20071128 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: 071272495 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 rrd180078.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)              November 28, 2007

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 November 28, 2007, Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) issued a press release, attached to and made part of this report, announcing the initiation of a Phase 3 clinical trial to evaluate epinastine nasal spray for the treatment of seasonal allergic rhinitis..

Item 9.01     Financial Statements and Exhibits.

(d) Exhibits

No.               Description

99.1              Press Release dated November 28, 2007

 

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: November 28, 2007

EXHIBIT INDEX

No. Description

99.1              Press Release dated November 28, 2007

EX-99.1 2 rrd180078_22450.htm _

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 INITIATES PHASE 3 TRIAL OF EPINASTINE NASAL SPRAY
FOR ALLERGIC RHINITIS

- Top-line Results Expected Second Quarter 2008 -

DURHAM, NC - November 28, 2007 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today the initiation of a Phase 3 clinical trial to evaluate epinastine nasal spray for the treatment of seasonal allergic rhinitis.

This Phase 3 clinical trial is a 14-day randomized, double-blind comparison of two concentrations of epinastine (0.1% and 0.15%) at two different spray volumes to placebo in approximately 750 subjects who have a documented history of seasonal allergic rhinitis (SAR) to mountain cedar pollen. This 5-arm trial will be conducted at nine clinical sites during the mountain cedar pollen season, which typically begins in December in south Texas.

The primary efficacy endpoint of this trial is the average change from baseline over the 14-day treatment period for the reflective Total Nasal Symptom Score (TNSS), defined as the sum of scores for runny nose, itchy nose and sneezing. Several secondary endpoints will also be evaluated, including change in nasal and ocular symptoms, as well as quality of life parameters and safety endpoints.

"We are pleased to initiate our Phase 3 program of epinastine nasal spray and look forward to reporting top-line results in the second quarter of 2008," stated Christy L. Shaffer, Ph.D., President and CEO of Inspire. "We believe that epinastine has the potential to offer patients an alternative to intranasal steroids for the treatment of allergic rhinitis."

The Phase 3 program is expected to consist of three pivotal Phase 3 clinical trials, including two SAR trials and one long-term safety trial in patients with perennial allergic rhinitis (PAR). In August 2007, Inspire initiated a required 6-month intranasal toxicology study of epinastine in a single animal species and expects to have results by mid-year 2008. The results from the 6-month study are necessary to begin the long-term safety trial, which will collect one-year safety data required for a potential New Drug Application.

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/allergy, and is developing products for dry eye, cystic fibrosis, allergic rhinitis and glaucoma. Elestat and Restasis are registered trademarks owned by Allergan, Inc. AzaSite is a 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 with respect to: the initiation, timing, structure or outcome of Inspire's Phase 3 clinical program to evaluate epinastine nasal spray for the treatment of allergic rhinitis, including without limitation, the number of Phase 3 clinical trials generally, the number of Phase 3 seasonal allergic rhinitis clinical trials, the number of Phase 3 perennial allergic rhinitis clinical trials, the primary or secondary endpoints relating to any such trials, the ability of the product candidate to offer patients an alternative to intranasal steroids, the types of trials, the indications, if any, for which approval may be sought or received, the timing and scope of any mountain cedar pollen season, the timing of the initiation and expected results of a Phase 3 clinical trial during any mountain cedar pollen season, the timing or results of an intranasal toxicology study, and the timing and success of one-year safety results. 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 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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