Healthcare Industry News: allergic rhinitis
News Release - December 21, 2006
ISTA Pharmaceuticals Submits Investigational New Drug Application for Eye Drop Formulation of Bepotastine for the Treatment of Allergic ConjunctivitisIRVINE, Calif., Dec. 21 (HSMN NewsFeed) -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA ), an ophthalmic pharmaceutical company, today announced it has submitted an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for its eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. ISTA intends to move bepotastine directly into Phase II/III clinical trials in the U.S. during the first quarter of 2007, based upon extensive preclinical research and early stage clinical evaluations that have been conducted in Japan by Senju Pharmaceutical Co., Ltd.
Bepotastine has three primary mechanisms of action. It is a non-sedating, selective antagonist of the histamine 1 (H1) receptor; it has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compound's primary mechanisms of action are believed to make it an effective treatment against the signs and symptoms of allergic conjunctivitis. An oral formulation of bepotastine has been approved in Japan for treatment of allergic rhinitis since July 2000.
"The IND for bepotastine, which comes only five months after ISTA in-licensed the compound from Senju Pharmaceuticals, is a critical milestone for this program. Given the early clinical work already conducted in this area by Senju, our plan is to move this drug directly into Phase II/III clinical evaluation during the first quarter of 2007," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "Approximately 20% of the U.S. population suffers from the signs of seasonal ocular allergy. We believe bepotastine, with its tri-mechanism approach, has the potential, if approved by FDA, of treating a significant percentage of patients in the U.S. who suffer from allergic conjunctivitis each allergy season."
In August 2006, ISTA licensed from Senju the exclusive North American rights to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis.
Bepotastine was approved in Japan for use in the treatment of allergic rhinitis and uriticaria/puritus in July 2000 and January 2002, respectively, and is marketed by Tanabe Seiyaku Co., Ltd. under the brand name TALION®. TALION® was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered the bepotastine compound. In 2001, Tanabe Seiyaku granted Senju exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $3.2 billion prescription ophthalmic industry include therapies for allergy, dry eye, vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain, and inflammation. The Company currently markets three products and is developing a strong product pipeline to fuel future growth and market share. The Company's product development and commercialization strategy is to launch a new product every 12 to 18 months, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' website at http://www.istavision.com.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to ISTA's goals of bringing a new product to market every 12 to 18 months and becoming the leading niche ophthalmic pharmaceutical company, its intention of moving bepotastine directly into Phase II/III clinical trials in the U.S. during the first quarter of 2007, and the potential of bepotastine, if approved by FDA ,of treating a significant percentage of patients in the U.S. who suffer from allergic conjunctivitis each allergy season are forward looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others: timely and successful implementation of ISTA's strategic initiatives; delays and uncertainties related to ISTA's research and development programs (including the difficulty of predicting the timing or outcome of product development efforts and the FDA or other regulatory agency approval or actions); uncertainties and risks regarding market acceptance of and demand for ISTA's approved products and the impact of competitive products and pricing; uncertainties and risks related to ISTA's ability to properly manage its growth; uncertainties and risks regarding the continued timely performance by ISTA's strategic partners of their respective obligations under existing collaborations and licensing arrangements; uncertainties and risks related to the continued availability of third party sourced products and raw materials on commercially reasonable terms, or at all; uncertainties and risks related to successful compliance with FDA and or other governmental regulations applicable to ISTA's facilities, products and/or business; uncertainties and risks related to the scope, validity, and enforceability of patents related to ISTA's products and technologies and the impact of patents and other intellectual property rights held by third parties; and such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2005, and its Form 10Q for the quarters ended March 31, 2006, June 30, 2006 and September 30, 2006.
Source: ISTA Pharmaceuticals
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