DURHAM, NC - May 4, 2009 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today the presentation of data related to post-marketing open- label clinical and nonclinical work with AzaSite(R) (azithromycin ophthalmic solution) 1% in poster presentations at the 2009 Association for Research in Vision and Ophthalmology (ARVO) annual meeting May 3-7, 2009 in Ft. Lauderdale, FL.
The following poster presentations will take place on Tuesday, May 5, 2009 from 8:30 AM - 10:15 AM in Hall B/C:
“Cell-Associated Azithromycin Confers Protection to Human Corneal Epithelial Cells from Staphylococcus aureus Infection” J.L. Boyer, W. Bodnar, C.S. Crean, L.M. Guogas Program #2659/Board #D891
“Efficacy of Topical Azithromycin Ophthalmic Solution 1.0% in the Treatment of Chronic Blepharitis Patients” D. Touhey, A. Shapiro, G. Torkildsen, R. Haque, R.C. Zink, R.P. Kowalski, F.S. Mah, S.C. Pflugfelder Program #2661/Board #D893
“Azithromycin Alters ProMMP-2 and TIMP-1 Following Corneal Wounding in an Experimental Animal Model of Diabetic Ocular Complications” J.L. Jacot, T.A. Jacot, S. Hahto, J. Helis, C.J. Sheppard, J.D. Sheppard, Jr., F.A. Lattanzio, Jr., P.B. Williams Program #2663/Board #D895
“Pharmacokinetics of Azithromycin and Moxifloxacin in Human Conjunctiva and Aqueous Humor During and After the Approved Dosing Regimens” W.C. Stewart, C.S. Crean, R.C. Zink, R. Haque, D.G. Hwang Program #2670/Board #D902
“Pharmacokinetic Modeling of Azithromycin in Rabbit Eyelids Following Topical Ocular Administration of AzaSite(R)” J.L. Vittitow, A.J. Parham, W.M. Bodnar, C.S. Crean Program #2672/Board #D904
“Modification of Meibomian Gland Lipids by Topical Azithromycin” G.N. Foulks, D. Borchman, M. Yappert Program #2676/Board #D908
“The Development of a Novel in vitro Efficacy Testing Method for a Cell- Associated Antibiotic” E.G. Romanowski, R.P. Kowalski, F.S. Mah, K.A. Yates, Y.J. Gordon, R.M.Q. Shanks Program #2678/Board #D910
The following poster presentations will take place on Thursday, May 7, 2009 from 8:30 AM - 10:15 AM in Hall B/C:
“Effect of Topical Azithromycin on Innate Immune Responses in Experimental Keratitis” Z. Sadrai, A.R. Hajrasouliha, S.K. Chauhan, D.R. Saban, M.H. Dastjerdi, R. Dana Program #5536/Board #A507
“Azithromycin Suppresses Pro-Inflammatory Mediators Stimulated by a TLR2 Ligand Zymosan in Human Corneal Epithelial Cells” N. Zhou, P. Ma, D.-Q. Li, S.C. Pflugfelder Program #5546/Board #A516
“Azithromycin Suppresses Bacterial Lipases Expressed by Staphylococcus” L.M. Guogas, J.L. Boyer Program #5943/Board #A549
Data in these poster presentations are based on clinical and nonclinical work funded by Inspire. The posters will be available on Inspire’s website, www.inspirepharm.com, following the conference.
About AzaSite(R)
AzaSite (azithromycin ophthalmic solution) 1% is a prescription medicine approved by the U.S. Food and Drug Administration for the treatment of bacterial conjunctivitis in adults and children 1 year of age and older. AzaSite is for topical ophthalmic use only. In clinical trials, the most frequently reported ocular adverse event was eye irritation, which occurred in 1% - 2% of patients. Please see full Prescribing Information for AzaSite at www.azasite.com. Inspire is pursuing an additional potential indication for AzaSite for the treatment of blepharitis.
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) for dry eye and denufosol tetrasodium for cystic fibrosis, which are both in Phase 3 development, and AzaSite(R) 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) for allergic conjunctivitis and royalties based on net sales of Restasis(R) 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. Specifically, no assurances can be made with respect to: Inspire’s ability 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 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.
