Inspire Announces Presentation at the North American Cystic Fibrosis Conference and Provides Enrollment Update for Phase 3 Cystic Fibrosis Trial

The poster, "Pharmacological Treatment of CF: Lessons Learned from a Phase 3 Clinical Trial" (T. Navratil, A. Schaberg, D. Mathews, C. Deans, T. Durham, F.J. Accurso), will be presented in Exhibit Hall B during the formal poster sessions on Thursday, October 15 from 11:50 am - 1:50 pm and Friday, October 16 from 7:00 am - 8:30 am local time. The poster describes the treatment regimen for a young, relatively mild patient population using a sample of 175 CF patients who were assigned to placebo in TIGER-1, Inspire's first Phase 3 clinical trial with denufosol.

"This analysis highlights the use of numerous medications that treat the respiratory conditions resulting from CF. These important findings underscore the need for early intervention disease-modifying therapies that may reduce the need for multiple pharmacological treatments," stated Frank J. Accurso, M.D., Head of Pulmonary Medicine, Director of Cystic Fibrosis Center at University of Colorado, Denver, and the lead principal investigator for TIGER-1.

The poster presentation will be available on Inspire's website, www.inspirepharm.com, following the conference.

The Company also announced today 430 out of the targeted 450 patients have been enrolled in its second Phase 3 clinical trial with denufosol for the treatment of CF, TIGER-2. This trial is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of 60 mg of denufosol versus placebo, administered three-times daily by jet nebulizer for 48 weeks in patients with FEV1 (Forced Expiratory Volume in One Second) greater than or equal to 75% and less than or equal to 110% predicted normal. Inspire continues to expect enrollment in TIGER-2 to be complete by the end of the year.

Throughout the development of denufosol, Inspire has worked closely with the Cystic Fibrosis Foundation (CFF) and its Therapeutics Development Network (TDN), a nationwide network of nearly 80 CF clinical research centers, and the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), a non-profit drug discovery and development affiliate. The CFF and its affiliates have provided information used in planning the denufosol development program, raised awareness about the need for patients to participate in clinical trials, and provided Inspire financial support for a key Phase 2 clinical trial.

About Denufosol Tetrasodium

Denufosol tetrasodium is a first-in-class receptor-mediated chloride channel activator that addresses the underlying ion transport defect in the lungs of patients with cystic fibrosis (CF). Denufosol is designed to enhance airway hydration and mucociliary clearance through receptor-mediated mechanisms that increase chloride secretion, inhibit sodium absorption and increase ciliary beat frequency. These integrated pharmacological actions are important to restoring airway clearance, maintaining lung function, and potentially delaying the progression of CF lung disease. Denufosol is targeted as an early intervention therapy for CF lung disease. This product candidate has been granted orphan drug and fast-track review status by the U.S. Food and Drug Administration (FDA) and orphan drug status by the European Medicines Agency (EMEA).

About Inspire

Inspire is a biopharmaceutical company focused on researching, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire's goal is to build and commercialize a sustainable portfolio of innovative new products based on its technical and scientific expertise. The most advanced compounds in Inspire's clinical pipeline are Prolacria(TM) (diquafosol tetrasodium ophthalmic solution) 2% for dry eye and denufosol tetrasodium for cystic fibrosis, which are both in Phase 3 development and AzaSite(R) (azithromycin ophthalmic solution) 1% for blepharitis, which is in Phase 2 development. Inspire receives revenues related to the promotion of AzaSite for bacterial conjunctivitis, the co-promotion of Elestat(R) (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and royalties based on net sales of Restasis(R) (cyclosporine ophthalmic emulsion) 0.05% for dry eye. 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. These statements are based upon the current beliefs and expectations of Inspire's management and are subject to significant risks and uncertainties. Specifically, there can be no assurance that enrollment in TIGER-2 will be complete by the end of the year or that denufosol will enhance airway hydration and mucociliary clearance through receptor-mediated mechanisms that increase chloride secretion, inhibit sodium absorption and increase ciliary beat frequency. Additionally, there can be no assurance that Inspire will be able to build and commercialize a sustainable portfolio of innovative new products based on its technical and scientific expertise. 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, 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 FDA. 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.

SOURCE: Inspire Pharmaceuticals, Inc.

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