IRVINE, Calif., Nov. 13 ISTA Pharmaceuticals,Inc. (Nasdaq: ISTA), today announced the Company filed a New Drug Application(NDA) with the U.S. Food and Drug Administration (FDA) for Bepreve(TM)(bepotastine ophthalmic solution). The Company is seeking approval for Bepreveas an eye drop treatment for ocular itching associated with allergicconjunctivitis.
ISTA filed the Bepreve NDA electronically, in eCTD format and using theFDA's Electronic Submission Gateway. Pending FDA validation of the electronicfile in the coming days and timely acceptance of the filing by the FDA, ISTAexpects a standard review of ten months from date of receipt.
In April of this year, ISTA announced highly statistically significantreductions in the primary study endpoint of ocular itching from thepreliminary analysis of its second and final Bepreve Phase III clinical study.In addition, the results showed Bepreve had a statistically significant effecton the rapidity of response and in certain secondary endpoints measuringadditional signs or symptoms of ocular allergy, including improvement in nasalsymptoms. There were no serious ocular adverse events reported in patientsdosed with Bepreve from the study.
About Bepreve(TM) (bepotastine ophthalmic solution)
Assuming both timely acceptance by the FDA of the Bepreve NDA for filingand approval to market, Bepreve would participate in the U.S. ocular allergymarket, which had estimated 2007 sales of approximately $560 million based ondata from IMS Health. Assuming approval, Bepreve would participate in ISTA'slargest market to date, as compared to ISTA's currently marketed products.
Bepreve has three primary mechanisms of action: it is a non-sedating,highly selective antagonist of the histamine (H1) receptor, it has astabilizing effect on mast cells, and it suppresses the migration into andactivation of eosinophils in inflamed tissues. The compound's primarymechanisms of action are believed to make it an effective treatment againstthe signs and symptoms of allergic conjunctivitis.
Bepotastine was approved in Japan for use as a systemic drug in thetreatment of allergic rhinitis and urticaria/pruritus in July 2000 and January2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation(formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION(R). TALION wasco-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discoveredbepotastine. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd.,exclusive worldwide rights, with the exception of certain Asian countries, todevelop, manufacture and market bepotastine for ophthalmic use. In 2006, ISTAlicensed the exclusive North American rights from Senju to an eye dropformulation of bepotastine for the treatment of allergic conjunctivitis.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA'sproducts and product candidates addressing the $4.7 billion U.S. prescriptionophthalmic industry include therapies for inflammation, ocular pain, glaucoma,allergy, and dry eye. The Company currently markets three products and isdeveloping a strong product pipeline to fuel future growth and market share.The Company's product development and commercialization strategy is to launcha new product every 12 to 18 months, thereby continuing its growth to becomethe leading niche ophthalmic pharmaceutical company in the U.S. For additionalinformation regarding ISTA, please visit ISTA Pharmaceuticals' website athttp://www.istavision.com.
Any statements contained in this press release that refer to future eventsor other non-historical matters are forward-looking statements. Withoutlimiting the foregoing, but by way of example, statements contained in thispress release related to the FDA's timely acceptance and approval of Bepreve,ISTA's belief that the FDA will review and take action on Bepreve within tenmonths of filing, ISTA's expectation of bringing a new product to market every12 to 18 months and becoming the leading niche ophthalmic pharmaceuticalcompany are forward-looking statements. Except as required by law, ISTAdisclaims any intent or obligation to update any forward-looking statements.These forward-looking statements are based on ISTA's expectations as of thedate of this press release and are subject to risks and uncertainties thatcould cause actual results to differ materially. Important factors that couldcause actual results to differ from current expectations include, amongothers, delays and uncertainties related to the FDA or other regulatory agencyapproval or actions; uncertainties and risks regarding market acceptance ofand demand for ISTA's approved products; and such other risks anduncertainties as detailed from time to time in ISTA's public filings with theU.S. Securities and Exchange Commission, including but not limited to ISTA'sAnnual Report on Form 10-K for the year ended December 31, 2007, and its mostrecent Quarterly Report on Form 10-Q for the quarter ended September 30, 2008.
SOURCE ISTA Pharmaceuticals, Inc.