IRVINE, CA--(Marketwire - January 06, 2012) - ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today announced that its partner Senju Pharmaceuticals Co. Ltd. has received a Notice of Allowance from the United States Patent and Trademark Office for Application Serial No 10/525,006 titled, "Aqueous Liquid Preparation Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic Acid" with claims that cover an optimized formulation of bromfenac. In October, ISTA reported statistically significant Phase 3 results for its product candidate, PROLENSA™ (bromfenac ophthalmic solution), which incorporates this proprietary formulation of bromfenac.
The Notice of Allowance concludes the substantive examination of this patent application and is expected to result in the issuance of a U.S. patent following completion of administrative processes. The patent is anticipated to issue in the first half of 2012 and expire in 2024.
"This notice of allowance is important to further broaden the intellectual property position for one of our key franchises," said Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "The bromfenac franchise has multiple barriers to entry -- existing Hatch-Waxman exclusivity for BROMDAY™ and Hatch-Waxman exclusivity upon potential approval of PROLENSA, this new allowed patent and additional patents pending. It is a critical step to our continued leadership in the $367 million ophthalmic nonsteroidal anti-inflammatory drug (NSAID) market in the U.S. Once issued, we believe that this patent will provide protection for not only PROLENSA, but also a potential bromfenac adjunct therapy for age-related macular degeneration (AMD)."
Dr. Anido continued, "We anticipate filing a New Drug Application (NDA) with the FDA for PROLENSA in the first half of 2012, with a commercial launch following approval planned in early 2013. Because PROLENSA has a lower-concentration of the active ingredient with high efficacy and safety, we plan to discontinue our current once-daily product, BROMDAY, sometime after the successful launch of PROLENSA. This is the same commercial strategy we successfully implemented in early 2011 for conversion of our twice-daily XIBROM™ prescriptions to once-daily BROMDAY."
PROLENSA™ (bromfenac ophthalmic solution) is being developed as a once-daily topical nonsteroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. PROLENSA incorporates a lower concentration of bromfenac than the company's current once-daily NSAID, BROMDAY (bromfenac ophthalmic solution) 0.09% in a new formulation. From 2005 until 2011, ISTA marketed XIBROM (bromfenac ophthalmic solution)® 0.09% in the U.S. for twice-daily use for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. In October of 2010, ISTA received FDA approval for once-daily BROMDAY and discontinued shipments of XIBROM in February 2011. ISTA acquired U.S. ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. Ltd. BROMDAY is currently the only once daily treatment option in the $367 million U.S. ophthalmic nonsteroidal anti-inflammatory market. PROLENSA is an investigational drug and 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.
BROMDAY™ (bromfenac ophthalmic solution) 0.09%, XIBROM (bromfenac ophthalmic solution)® 0.09% and PROLENSA™ (bromfenac ophthalmic solution) are trademarks of ISTA Pharmaceuticals, Inc.
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 filing of a new drug application with the FDA, the FDA's actions with respect thereto, potential launch of PROLENSA in 2013 and subsequent withdrawal of BROMDAY, patent issuance, and the protections afforded by Hatch-Waxman exclusivity and patents, 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 10-Q for quarters ended March 31, June 30, and September 30, 2011.