-----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, LdsL8sbic+M4skV3bqt2iDYFwnOKlxlAWytDW0D3Pi51NRzzk3Nb3SKK27qrkgKv 9gorxEMX/SgJgdD/haTofA== 0001193125-03-027193.txt : 20030731 0001193125-03-027193.hdr.sgml : 20030731 20030731163532 ACCESSION NUMBER: 0001193125-03-027193 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20030731 ITEM INFORMATION: Other events FILED AS OF DATE: 20030731 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: 03815010 BUSINESS ADDRESS: STREET 1: 4222 EMPEROR BLVD STE 470 CITY: DURHAM STATE: NC ZIP: 27703-8466 BUSINESS PHONE: 9199419777 MAIL ADDRESS: STREET 1: 4222 EMPEROR BLVD STREET 2: STE 470 CITY: DURHAM STATE: NC ZIP: 27703-8466 8-K 1 d8k.htm CURRENT REPORT Current Report

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)                    July 31, 2003


 

INSPIRE PHARMACEUTICALS, INC.


(Exact Name of Registrant as Specified in Charter)

 

                        Delaware                                                              000-31135                                                      04-3209022


(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

4222 Emperor Boulevard, Suite 470, 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)

 


Item 5.            Other Events.

 

On July 31, 2003, Inspire Pharmaceuticals, Inc. issued the following press release:

 

“INSPIRE PHARMACEUTICALS’ DIQUAFOSOL NDA GRANTED PRIORITY REVIEW BY

THE FDA

 

“DURHAM, NC – July 31, 2003 - Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for Inspire’s New Drug Application (NDA) for diquafosol tetrasodium ophthalmic solution, for the treatment of dry eye. Priority Review is an FDA procedure designed to accelerate the review of potential products that address a significant unmet medical need. The designation of Priority Review sets the target date for initial FDA action at 6 months from the NDA submission date. The NDA submission date for diquafosol was June 27, 2003. Official notification from the FDA on filability of the NDA is expected in September, which is within the usual timeframe for such notification.

 

“ ‘We are pleased that the FDA has granted Priority Review for diquafosol and we have already begun an active dialogue with the FDA on various aspects of the submission,’ said Christy L. Shaffer, Ph.D., CEO of Inspire. ‘We are continuing our efforts toward building a commercial infrastructure to co-promote this potential new product with our partner, Allergan, Inc. Given the possibility of accelerated action on the diquafosol NDA, we intend to have our sales force ready for a potential first quarter 2004 launch.’

 

“About Dry Eye

“Dry eye is a painful, burning and irritating condition involving abnormalities and deficiencies in the tear film due to a variety of causes. It affects approximately 10 million North Americans and is one of the most frequent patient complaints reported to ophthalmologists and optometrists. The majority of dry eye patients rely on artificial tears to relieve symptoms. Allergan’s Restasis is the first and only pharmacologically active prescription product approved for patients with chronic dry eye disease.

 

“About Inspire

“Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body’s innate defense mechanisms of mucosal hydration and mucociliary clearance, as well as other non-mucosal disorders. Mucosal defense mechanisms are the natural way that the body defends its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire’s lead product candidates target ophthalmic and respiratory diseases with inadequate current treatments and which represent large therapeutic market opportunities. Inspire has development and commercialization alliances with Allergan, Inc., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd., and has a collaboration with Cystic Fibrosis Foundation Therapeutics, Inc. Inspire’s products are based on proprietary technology relating to P2Y2 receptors and to non-P2Y2 receptors that show therapeutic promise, including P2Y12.

 

“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 and earnings expectations, intellectual property rights and litigation, competitive products, results of clinical trials, the need for additional research and testing, delays in manufacturing, funding and the timing and content of decisions made by regulatory authorities, including the United States Food and Drug Administration. Further information regarding factors that could affect Inspire’s results is included in Inspire’s filings with the Securities 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.”

 

# # #


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

     Chief Executive Officer

 

Dated: July 31, 2003

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