lSTA1’IunnIceutica1sAnnnunces1ssua1meofUS PduIt£orPROLENSA(l'M)
`
`K E T
`M
`W I R E D
`
`Frangais [ About Us 1 Careers[ Media Partners] Blog
`SITE
`NEWS
`
`lsearch
`
`«f
`
`| I | 5 | In | 3*
`
`PRODUCTS
`
`\
`
`SOLUTIONS
`
`\ NEWSROOM \ RESOURCES
`
`\ CONTACT us
`
`News Room
`
`f '
`
`8+ ® gPrintFriendly
`
`<Share
`
`SOURCE: ISTA Pharmaceuticals
`
`I S
`
`Pharmaceuticals‘
`
`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 Phamiaceuticals, Inc. (NASDAQ: ISTA) today announced that the United States Patent and
`Trademark Oflice has issued Patent No. 8,129,431 with claims covering PROLENSA" (bromfenac ophthalmic solution), ISTA's once-daily
`topical nonsteroidal antnntlammatory 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 tenn 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 Ollicer 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 oncedaily use currently prescribed with BROMDAY. We
`anticipate tiling a New Dmg 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
`etlicacy and safety, we plan to discontinue BROMDAY sometime alter 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—daiIy 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 dmg and not yet available for commercial use.
`ABOUT ISTA PHARMACEUTICALS
`ISTA Pharmaceutimls, 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 cunently 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
`
`littpzl/www marketwiled mm/pe&tebwim bmnmd-wpnm-hfmbs-uMa¢kb163flB 1mn[12/16/2015 11:33:14 AM]
`
`Page 1 of 3
`
`SENJU EXHIBIT 2230
`
`LUPIN v. SENJU
`IPR2015—0l100
`
`

`
`ISTAPhztmaocInicalsAmunmoesIssuanccofUS PatentfixPROI.ENSA(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 PROLENSAW (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 21 E 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 lSTA'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 lSTA's public filings with the U.S_ Securities and Exchange Commission, including but not limited to lSTA's Annual Report on Fonn 10-K
`for the year ended December 31, 2011.
`
`CONTACT INFORMATION
`
`CONTACTS
`For Investor Relations:
`Lauren Silvemail
`949-788-5302
`
`|silvernai|@istavision_com
`
`Jeanie Herbert
`949-789-3159
`
`jherbert@istavision.com
`
`Kathy Galante
`Burns McClellan
`212-213-0006
`
`kgaIante@bumsmc.com
`
`For General Media:
`Justin Jackson
`Burns McClellan
`212-21 3-0006
`
`jjackson@bumsmc.com
`
`For Trade Media:
`Tad Heitmann
`BioComm Network
`714-273-2937
`
`theitmann@BioCommNetwork.com
`
`Web Site: http://www.istavision.com
`
`f I an 8* ® gPrintFriend|y 4 Share
`News Room
`
`VIEW RELATED NEWS
`
`About this company
`
`ISTA Pharmaceuticals
`
`From this industry
`
`Pharmaceuticals and Biotech
`
`Page 2 of 3
`
`Imp://www markctwired wduewnlusdku-phzmwufiak-amumwixrmwoflwfamn-fa-pohm-msbq-im—163M23 htm[1?Jl6fZ0lS 11:33:14 AM]
`
`

`
`ISTAP|m:maoanicalsAnnoImcesIssuanccofUS PalJentfiarPROLENSA('l'M)
`
`From this sub—industry
`
`Biotech
`Drugs
`Equipment and Supplies
`Trials
`
`See all RSS Newsfeeds
`
`About Marketwired
`
`Products
`
`Resources
`
`Newsroom
`
`Connect With Us
`
`Executive Team
`Marketwired News
`Careers
`Community Builders
`Privacy
`Site Map
`Accessibility
`
`Marketwired Resonate
`Marketwired Influencers
`News Distribution
`IR/PR Newsroom (Impress)
`Media Database (Mediahub)
`Social Media Reports
`
`Brochures
`Case Studies
`E-Books I Tip Sheets
`Webinars I Videos
`Testimonials
`
`All News
`Headlines Only
`Advanced Search
`RSS Newsfeeds
`Hot Ofi the Wire
`Personal Beat
`CASL Compliance
`
`copyngne2o15Manceiwireu LP. Al rigntsresecveu. |_ega|
`
`" 1,. '
`w
`
`+
`
`Page 3 of 3
`
`hflp:l/www mztketwired wWue$4elasdim—flmmwufial&mmmwimmwof4wfimun-fa-polmn-msdq—im—163M23 htm[l?Jl6/2015 11:33:14 AM]