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`SOURCE: ISTA Pharmaceuticals
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`March 27, 2012 07:30 ET
`
`ISTA Pharmaceuticals Announces Issuance of U.S. Patent for PROLENSA™
`Patent Term Adjustment Extends Intellectual Property Protection for ISTA's Bromfenac-Based Drug Candidates Through September
` 2025
`
`IRVINE, CA--(Marketwire - Mar 27, 2012) - ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) today announced that the United States Patent and
` Trademark Office has issued Patent No. 8,129,431 with claims covering PROLENSA™ (bromfenac ophthalmic solution), ISTA's once-daily
` topical nonsteroidal anti-inflammatory product for the treatment of ocular inflammation and pain following cataract surgery. The patent was issued
` to ISTA's licensor, Senju Pharmaceuticals Co. Ltd., and was granted a patent term adjustment that extends the patent life originally set to expire
` January 2024 to September 2025.
`"The issuance of this patent broadens and further extends the intellectual property position for pipeline products in our bromfenac franchise," said
` Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "As noted earlier in the year, our bromfenac franchise has multiple
` barriers to entry, including Hatch-Waxman exclusivity and additional pending patents. This patent should provide protection for not only our new
` product candidate PROLENSA, but also a potential bromfenac adjunct therapy for age-related macular degeneration (AMD)."
`Dr. Anido continued, "The new, optimized formulation used for PROLENSA enhances the penetration of bromfenac into ocular tissues, allowing
` us to lower the concentration of bromfenac, while maintaining the convenience of once-daily use currently prescribed with BROMDAY. 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 the advantage of offering a lower concentration of the active ingredient bromfenac with high
` efficacy and safety, we plan to discontinue BROMDAY sometime after the successful launch of PROLENSA."
`ABOUT PROLENSA™
`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, optimized 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 $370 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
`
`http://www.marketwired.com/press-release/ista-pharmaceuticals-announces-issuance-of-us-patent-for-prolensa-nasdaq-ista-1636423.htm[12/16/2015 11:33:14 AM]
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`Page 1 of 3
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`SENJU EXHIBIT 2230
`LUPIN v. SENJU
`IPR2015-01097
`
`
`
`ISTA Pharmaceuticals Announces Issuance of U.S. Patent for PROLENSA(TM)
`
` various stages of development to treat dry eye, ocular inflammation and pain, and nasal allergies. Headquartered in Irvine, California, ISTA
` generated revenues of $160 million in 2011. 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.
`FORWARD-LOOKING STATEMENTS
`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 protections provided by patents
` and statutory provisions, filing and acceptance for review of a new drug application with the U.S. Food and Drug Administration, potential
` commercial launch in 2013, future discontinuation of BROMDAY, and potential for the use of bromfenac for AMD 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, 2011.
`
`CONTACT INFORMATION
`
`CONTACTS
`For Investor Relations:
` Lauren Silvernail
`949-788-5302
`lsilvernail@istavision.com
`
` Jeanie Herbert
`949-789-3159
`jherbert@istavision.com
`
` Kathy Galante
` Burns McClellan
`212-213-0006
`kgalante@burnsmc.com
`
` For General Media:
` Justin Jackson
` Burns McClellan
`212-213-0006
`jjackson@burnsmc.com
`
` For Trade Media:
` Tad Heitmann
` BioComm Network
`714-273-2937
`theitmann@BioCommNetwork.com
`
` Web Site: http://www.istavision.com
`
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`http://www.marketwired.com/press-release/ista-pharmaceuticals-announces-issuance-of-us-patent-for-prolensa-nasdaq-ista-1636423.htm[12/16/2015 11:33:14 AM]
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`ISTA Pharmaceuticals Announces Issuance of U.S. Patent for PROLENSA(TM)
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`http://www.marketwired.com/press-release/ista-pharmaceuticals-announces-issuance-of-us-patent-for-prolensa-nasdaq-ista-1636423.htm[12/16/2015 11:33:14 AM]
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