-----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, QvcaYgkbNS2tgLKf+B8zNAjTyNzukVI62zb+HfLsVnyilCcwMeUwu0XhkbXzD1gg +dtdAEy9B8prtbjSnG7N7g== 0001181431-06-034392.txt : 20060601 0001181431-06-034392.hdr.sgml : 20060601 20060601172545 ACCESSION NUMBER: 0001181431-06-034392 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060601 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060601 DATE AS OF CHANGE: 20060601 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: 06880899 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 rrd120337.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)               May 31, 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 May 31, 2006, Inspire Pharmaceuticals, Inc. issued a press release, attached to and made part of this report, announcing plans to file an Investigational New Drug (IND) application and begin Phase 2 clinical testing of intranasal epinastine for the treatment of seasonal allergic rhinitis.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

No.            Description

99.1           Press Release dated May 31, 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: June 1, 2006

EXHIBIT INDEX

No.            Description

99.1           Press Release dated May 31, 2006

EX-99.1 2 rrd120337_13887.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 ANNOUNCES PLANS TO BEGIN PHASE 2 TESTING OF INTRANASAL EPINASTINE FOR SEASONAL ALLERGIC RHINITIS

- Pre-Investigational New Drug Meeting Completed With FDA -

DURHAM, NC -- May 31, 2006 -- Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today plans to file an Investigational New Drug (IND) application and begin Phase 2 clinical testing of intranasal epinastine for the treatment of seasonal allergic rhinitis, following the recent completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA).

"We are pleased that the extensive data package on epinastine allows us to progress into Phase 2 clinical testing, following our planned IND submission," said Christy L. Shaffer, Ph.D., President and CEO of Inspire. "This program fits nicely into our existing commercial operation, provides access to an attractive market and enables us to leverage both our development expertise in the respiratory/allergy therapeutic area and our knowledge of epinastine in the ocular form, Elestat®."

Inspire expects to submit the IND application for intranasal epinastine in the third quarter of 2006 and begin Phase 2 clinical testing by year-end 2006. The Phase 2 program will include clinical and toxicology studies to determine the optimal formulation and dose. The primary Phase 2 trial is expected to be a 14-day dose-ranging trial in 600-700 subjects with seasonal allergies.

About Rhinitis

Rhinitis is a condition that primarily results from exposure to allergens, either at specific times of the year (seasonal allergic rhinitis) or year-round (perennial allergic rhinitis), or from exposure to irritants, such as cigarette smoke or perfume. Symptoms most often include nasal congestion or stuffiness, rhinorrhea (runny nose) and nasal itching. In the United States, allergic rhinitis (AR) affects approximately 40 million people, according to the American Academy of Allergy, Asthma & Immunology. Annual sales of intranasal prescription products to treat AR are estimated by IMS Health to total more than $2.8 billion. The treatments currently available include primarily prescription and over-the-counter antihistamines, decongestants and nasal corticosteroids.

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, allergic rhinitis and acute cardiac care. 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 can make no assurance that an IND application for intranasal epinastine will be submitted in the third quarte r or that Phase 2 testing will begin in 2006. Even if testing begins in 2006, the clinical testing may not be successful. 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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