-----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, CUT1rzjjyctxJLFjae66HaYN9SFBP/AwSLJg2Y1eLf7EwkZHLX0za2DakcNgurZX Xkqg7icNTt3355X8H+ONGA== 0001193125-08-195781.txt : 20080915 0001193125-08-195781.hdr.sgml : 20080915 20080915115627 ACCESSION NUMBER: 0001193125-08-195781 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20080911 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080915 DATE AS OF CHANGE: 20080915 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: 081070909 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 d8k.htm FORM 8-K Form 8-K

 

 

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) September 11, 2008

 

 

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)  

(IRS Employer

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 September 11, 2008, Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) issued a press release, attached to and made part of this report, announcing plans relating to INS117548 Ophthalmic Solution for the treatment of glaucoma.

 

Item 9.01 Financial Statements and Exhibits.

 

(d)   Exhibits

No.

 

Description

99.1   Press Release dated September 11, 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: September 11, 2008


EXHIBIT INDEX

 

No.

 

Description

99.1   Press Release dated September 11, 2008
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

For Immediate Release

 

Investor Contact:   Media Contact:
Inspire Pharmaceuticals, Inc.   BMC Communications
Jenny Kobin   Dan Budwick
VP, Investor Relations and Corporate Communications   (973) 271-6085
(919) 941-9777, Extension 219  

INSPIRE ANNOUNCES PLANS FOR CLINICAL TESTING OF NEW COMPOUND

INS117548 FOR THE TREATMENT OF GLAUCOMA

DURHAM, NC - - September 11, 2008 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that the standard 30-day review period by the U.S. Food and Drug Administration (FDA) relating to Inspire’s Investigational New Drug Application (IND) for INS117548 Ophthalmic Solution for the treatment of glaucoma has concluded and clinical testing can proceed.

Inspire is currently targeting the initiation of a Phase 1 clinical trial by the end of 2008 to evaluate the tolerability and efficacy of this product candidate in subjects with early stage glaucoma or ocular hypertension.

INS117548 is a rho kinase inhibitor designed to lower intraocular pressure (IOP) in glaucoma patients by disrupting the actin cytoskeleton (cellular skeleton) of the trabecular meshwork, an ocular tissue responsible for most of the outflow of aqueous humor. The elevated IOP commonly associated with glaucoma is believed to arise from impairment in the function of the trabecular meshwork. Currently, none of the FDA-approved, IOP-lowering medications directly target this tissue, so INS117548 may provide a novel approach for lowering IOP by directly enhancing the physiologic function of the trabecular meshwork.

The technology platform that led to the discovery of INS117548 is based on a license agreement with the Wisconsin Alumni Research Foundation (WARF) for use in developing and commercializing new therapies to treat glaucoma. The related patents are based upon research conducted by Paul Kaufman, M.D., Professor and Chair, Department of Ophthalmology and Visual Sciences of the University of Wisconsin-Madison, and Benjamin Geiger, Ph.D., Professor of Molecular Cell and Tumor Biology, and Dean of Biology at the Weizmann Institute of Science in Israel. Inspire has an additional compound, INS115644, related to this platform that is also in Phase 1 clinical testing.

Dr. Kaufman stated, “There remains an important need to identify new treatments for glaucoma, a leading cause of blindness affecting nearly 70 million people worldwide. For many patients, current treatments have limited benefit or multiple eye drops must be used to keep the disease under control. Inspire has made excellent progress in moving this program from the preclinical stage to human clinical testing with multiple compounds being studied to provide critical information about this targeted approach.”

LOGO


About Inspire

Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire employs a U.S. sales force for the promotion of AzaSite® (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat® (epinastine HCI ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis® (cyclosporine ophthalmic emulsion) 0.05% for dry eye. Inspire is currently 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 assurance can be made with respect to the timing of the initiation of a Phase 1 clinical trial or the outcome of such a trial, including the ability to evaluate the tolerability and efficacy of the product candidate; the ability of INS117548 to provide a novel approach for lowering IOP and impact the physiologic function of the trabecular meshwork; and the timing or outcome of clinical testing of INS115644, including Phase 1 clinical testing. 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, 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.

# # #

LOGO

 

Page 2

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