IRVINE, Calif., Sept. 8 ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced the U.S. Food and Drug Administration (FDA) has approved Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.
"Bepreve offers a new, safe and effective way to treat the itching caused by ocular allergies. We expect to have Bepreve available to ophthalmologists and patients in the United States in the fourth quarter of 2009," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "Because of the timing of this approval and the strength of our underlying business, we will accelerate all of the launch activities immediately, including the scale-up of the sales force. This will allow us not only to finish this year very strongly but also enter next year with an expanded sales force in place. Bepreve and Xibrom will share the top spot on our promotional activities, but we will continue to devote time and energy to Istalol, too."
ISTA conducted multiple clinical studies, evaluating the safety, efficacy, onset and duration of effect of Bepreve. Two Phase 3 double-masked, placebo-controlled, conjunctival allergen challenge (CAC) studies demonstrated Bepreve significantly reduced ocular itching. In addition, the studies achieved statistical significance and demonstrated Bepreve's rapid onset of action in providing relief to persons with ocular itching associated with allergic conjunctivitis.
"Patients who experience ocular itching due to allergies want comfortable, quick and long-lasting relief for their eyes. Bepreve is the first truly new treatment for allergic conjunctivitis approved in several years. Allergic conjunctivitis, not to be confused with viral or bacterial conjunctivitis or pink eye, is an eye allergy that often results in ocular itching, and I am excited patients will have this new treatment option," commented Gregg J. Berdy, M.D., Assistant Professor of Clinical Ophthalmology, Washington University School of Medicine.
Dr. Anido concluded, "As we are accelerating our launch timing to the fourth quarter and are expanding our sales force, we now expect to be able to recognize Bepreve revenue this year. In addition, Xibrom and Istalol are performing particularly well year to date, giving us confidence to increase our full-year 2009 net product revenue guidance for our four marketed products to $101 million to $104 million. Our total net revenue for full-year 2009, including net product revenue and $2.9 million from the one-time recognition of deferred revenue resulting from our previously disclosed modification of our partnership with Otsuka, is now expected to be $104 million to $107 million. We also are reiterating our guidance that ISTA will be operating income neutral in 2009, as our increased net revenue will offset the costs associated with launching Bepreve and expanding our sales force."
About the U.S. Ocular Allergy Market
Approximately 60 to 90 million Americans suffer from ocular allergy. Allergic conjunctivitis, the most common allergy affecting the eyes, is caused by exposure to certain allergens such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Ocular itching is the most common symptom of ocular allergy, reported by more than 75% of allergy patients. Current treatments for allergic conjunctivitis include antihistamines, mast cell stabilizers and anti-inflammatories. Based on data from IMS Health, in 2008 approximately 6.6 million prescriptions were filled for ocular allergy treatments, resulting in sales of approximately $560 million.
About Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%
Bepreve 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 are believed to make it an effective treatment against ocular itching associated with allergic conjunctivitis.
Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION(R). TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine. 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 for ophthalmic use. In 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. In 2007, ISTA licensed exclusive North American rights to nasal dosage forms of bepotastine from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.
INDICATIONS AND USAGE
Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
DOSAGE AND ADMINISTRATION
Instill one drop of Bepreve(TM) into the affected eye(s) twice a day (BID).
WARNINGS AND PRECAUTIONS
To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use.
Bepreve(TM) should not be used to treat contact lens-related irritation.
Remove contact lenses prior to instillation of Bepreve(TM).
The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
Full prescribing information is available on ISTA Pharmaceuticals' website at http://www.istavision.com
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is the fourth largest branded ophthalmic pharmaceutical business in the U.S. ISTA's four marketed products plus its product candidates include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company is developing a strong product pipeline to fuel future growth and market share, 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.
Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%, Xibrom(TM) (bromfenac ophthalmic solution) 0.09%, and Istalol(R) (timolol maleate ophthalmic solution) 0.5% are trademarks of ISTA Pharmaceuticals.
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 financial guidance for 2009, the expansion of ISTA's sales force, and ISTA's anticipated devotion of resources toward the marketing of Bepreve, Xibrom and Istalol 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, uncertainties and risks regarding market acceptance of and demand for ISTA's approved products; 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, 2008, and its most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2009.
SOURCE ISTA Pharmaceuticals, Inc.