ISTA Pharmaceuticals Initiates Phase 2 Clinical Study of BEPOSONE(TM) (Bepotastine Besilate - Steroid Combination Nasal Spray) for the Treatment of Symptoms Associated With Seasonal Allergic Rhinitis
IRVINE, CA -- (MARKET WIRE) -- 01/04/12 -- ISTA Pharmaceuticals, Inc. (ISTA) (NASDAQ: ISTA) today announced it has initiated a Phase 2 clinical study of its BEPOSONE" nasal spray combining bepotastine besilate with a steroid for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group environmental study will evaluate the safety and efficacy of the combination nasal spray, dosed twice daily, in patients presenting with allergic rhinitis caused by one of the most potent seasonal allergy triggers, Mountain Cedar pollen.
ISTA expects to enroll approximately 600 patients in Texas who will be treated with either the bepotastine besilate-steroid combination nasal spray, nasal spray containing only one of the active agents, or placebo nasal spray for two weeks. Patients will grade both individual nasal and ocular symptoms on a daily basis during the treatment period.
"The Phase 2 results from our first Texas study of BEPOMAX" (bepotastine besilate) as a single agent nasal spray, which we announced in April, showed each of three concentrations achieved statistically significant improvements in patients' nasal symptoms compared to placebo following exposure to Mountain Cedar pollen," stated Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals. "Based upon extensive conversations with allergists to determine their prescribing habits and treatment preferences, we expanded our bepotastine besilate nasal spray program to add development of a bepotastine-steroid combination product since antihistamines and steroids are often prescribed together for treatment of seasonal allergic rhinitis. With one marketed eye care product for ocular itch associated with allergic conjunctivitis, BEPREVE®, and the potential for two nasal formulations for allergic rhinitis, BEPOMAX and BEPOSONE, our bepotastine besilate therapeutic franchise could offer important options to address the majority of patients' seasonal allergy symptoms."
ISTA submitted the Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for BEPOSONE nasal spray in October 2011. The company expects to report results of this Phase 2 clinical study for BEPOSONE in the first half of 2012.
ABOUT THE ALLERGIC RHINITIS MARKET
According to the American Academy of Allergy Asthma & Immunology (AAAAI), approximately 60 million Americans are affected by allergic rhinitis, an inflammation of the nasal passages caused by exposure to certain allergens, such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Allergic rhinitis is characterized by a number of symptoms, including sneezing, nasal congestion, nasal itching and runny nose. The eyes, ears, sinuses and throat also can be affected. Current treatments for allergic rhinitis include antihistamines, mast cell stabilizers, anti-inflammatories, and steroids. Based on data from IMS Health in the U.S., approximately 46.7 million prescriptions were filled for nasal allergy treatments in 2010, resulting in sales of approximately $2.5 billion.
ABOUT BEPOTASTINE BESILATE
Bepotastine besilate is a non-sedating, highly selective antagonist of the histamine 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 suggest that it is a potentially effective treatment for nasal symptoms associated with seasonal allergic rhinitis.
Bepotastine besilate has been approved in Japan for systemic use in the treatment of allergic rhinitis since 2000 and for urticaria/dermal prurituses since 2002. It is marketed as an oral tablet in Japan by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION®. TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine besilate. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine besilate for ophthalmic use. In 2006, ISTA licensed the exclusive North American ophthalmic rights to bepotastine besilate from Senju. In 2007, ISTA licensed exclusive North American rights to nasal dosage forms of bepotastine besilate from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine besilate for allergy treatment.
ISTA's eye drop formulation of bepotastine besilate, BEPREVE® (bepotastine besilate ophthalmic solution) 1.5%, was approved by the U.S. Food and Drug Administration (FDA) in September 2009 for the treatment of ocular itching associated with allergic conjunctivitis. BEPOSONE" and BEPOMAX" nasal spray formulations for seasonal allergic rhinitis are currently investigational drugs in clinical studies and are not yet available for commercial use.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc. is a fast growing and the third largest branded prescription eye care business in the United States with an expanding focus on allergy therapeutics. ISTA currently markets four products, including treatments for ocular inflammation and pain post-cataract surgery, glaucoma and ocular itching associated with allergic conjunctivitis. The company's development pipeline contains additional candidates in various stages of development to treat dry eye, ocular inflammation and pain, and nasal allergies. Headquartered in Irvine, California, ISTA generated revenues of $156.5 million in 2010. For additional information about ISTA, please visit the corporate website at www.istavision.com.
BEPREVE®, BEPOSONE" and BEPOMAX" are trademarks that are owned by ISTA Pharmaceuticals, Inc. TALION® is a trademark of Mitsubishi Tanabe Pharma Corporation.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Reform Act of 1995. Without limiting the foregoing, but by way of example, statements contained in this press release related to the enrollment and completion of the Phase 2 study, the release of preliminary data from the Phase 2 study in the first half of 2012, and the potential of our bepotastine besilate therapeutic franchise 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, delays and uncertainties related to the FDA or other regulatory agency approval or actions 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, 2010, and its Quarterly Report on Forms 10-Q for the quarters ended March 31, June 30 and September 30, 2011.
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Source: ISTA Pharmaceuticals