Inspire Announces Peer-Reviewed Publications Related to Denufosol for Cystic Fibrosis
DURHAM, N.C., Aug. 6, 2008--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today publication of two papers related to the denufosol for cystic fibrosis development program in peer-reviewed journals.
The first paper, “Denufosol: A Review of Studies with Inhaled P2Y2 Agonists that led to Phase 3” (D. Kellerman, A. Rossi Mospan, J. Engels, A. Schaberg, J. Gorden, L. Smiley), was published in Pulmonary Pharmacology & Therapeutics August 2008, Volume 21, Issue 4; pgs 600-607.
This review included previously published results from Phase 1 and 2 clinical trials with denufosol. Key findings highlighted in the paper provide rationale for the development of denufosol as a potential treatment for cystic fibrosis.
The second paper, “Experience Using Centralized Spirometry in the Phase 2 Randomized, Placebo-controlled, Double-blind Trial of Denufosol in Patients with Mild to Moderate Cystic Fibrosis” (C.H. Goss, E.F. McKone, D. Mathews, D. Kerr, J.S. Wanger, S.P. Millard, the Cystic Fibrosis Therapeutics Development Network), was published in the Journal of Cystic Fibrosis March 2008, Volume 7, Issue 2; pgs 147-153.
This paper examined the effects on the quality and variability in pulmonary function test measures when centralized spirometry services are utilized. The results showed that centralized spirometry has the potential to reduce variability in a CF trial and that spirometry in this Phase 2 trial was of high quality with a low rate of over-read discrepancy. Inspire is using centralized spirometry in its Phase 3 trials with denufosol.
About Denufosol
Denufosol is designed to enhance the lung’s innate mucosal hydration and mucociliary clearance mechanisms, which in CF patients are impaired due to a genetic defect. By hydrating airways and stimulating mucociliary clearance through activation of the P2Y2 receptor, denufosol can potentially help keep the lungs of CF patients clear of thickened mucus, reduce infections and limit the damage that occurs as a consequence of the prolonged retention of thick and tacky infected secretions.
Denufosol is currently in Phase 3 testing for the treatment of cystic fibrosis. Positive top-line results from the first Phase 3 trial, TIGER-1, were announced in June 2008. Denufosol for the treatment of cystic fibrosis has been granted Fast Track designation and orphan drug status in the United States by the FDA and orphan drug designation in Europe by the European Medicines Agency (EMEA). Inspire holds world-wide rights for denufosol.
About Inspire
Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire is currently developing products for dry eye, cystic fibrosis and glaucoma. 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. 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. 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.
Contacts
Investor Contact:
Inspire Pharmaceuticals, Inc.
Jenny Kobin
VP, Investor Relations and Corporate Communications
919-941-9777, Ext. 219
or
Media Contact:
BMC Communications
Dan Budwick, 973-271-6085
