!STA Phannaceuticals Announces Issuance ofU S Patent for PROLENSA(fM)
`
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`SOURCE: ISTA Pharmaceuticals
`
`f
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`I S l A Pharmaceuticals•
`
`March 27, 2012 07:30 ET
`
`ISTA Pharmaceuticals Announces Issuance of U.S. Patent for PROLENSATM
`
`Patent Term Adj ustment Extend s Intellectual Property Prot ection 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 TM
`PROLENSA TM (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 unti12011,
`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 201 1. 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 PHARMA CEUTICA LS
`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:J/www marketwired com/press-release/ista-pharmaceuticals-announces-issuance-<>f-us-patent-for-prolensa-nasdaq-ista- 1636423 htm{ 12/1612015 I I :33: 14 AM]
`
`PAGE 1 OF3
`
`SENJU EXHIBIT 2230
`INNOPHARMA v SENJU
`IPR2015-00903
`
`
`
`MARK ET
`WIRED
`
`Fran~ais I About Us I Careers I Media Partners I Slog
`
`f I "~ I ll, I in I s•
`
`!search
`
`SITE 111 1
`
`sysomos
`
`PRODUCTS
`
`\ SOLUTIONS
`
`\ NEWSROOM
`
`\ RESOURCES
`
`\ CONTACT US
`
`NewsRoom
`
`. 1n g+ ® I A Print Friend~ I < Share
`
`SOURCE: ISTA Pharmaceuticals
`
`f
`~
`I S l A Pharmaceuticals•
`
`March 27, 2012 07:30 ET
`
`ISTA Pharmaceuticals Announces Issuance of U.S. Patent for PROLENSATM
`
`Patent Term Adj ustment Extend s Intellectual Property Prot ection 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 TM
`PROLENSA TM (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 unti12011,
`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 201 1. 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 PHARMA CEUTICA LS
`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:J/www marketwired com/press-release/ista-pharmaceuticals-announces-issuance-<>f-us-patent-for-prolensa-nasdaq-ista- 1636423 htm{ 12/1612015 I I :33: 14 AM]
`
`PAGE 1 OF3
`
`SENJU EXHIBIT 2230
`INNOPHARMA v SENJU
`IPR2015-00903
`
`
`
`ISTA Pharmaceuticals Annotmces Issuance ofU 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 27 A 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, 1ST A disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements
`are based on 1ST A'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
`Bums McClellan
`212-213-0006
`kgalante@bumsmc.com
`
`For General Media:
`Justin Jackson
`Bums McClellan
`212-213-0006
`jjackson@bumsmc.com
`
`For Trade Media:
`Tad Heitmann
`BioComm Network
`714-273-2937
`theitmann@BioCommNetwork.com
`
`Web Site: http://www.istavision.com
`
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`PAGE20F3
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`http://www marketwired com/press-release/ista-pharmaceuticals-annotmces-issuance-of-us-patent-for -prolensa-nasdaq-ista-1636423 htm[ 12/16/20 15 11 :3 3: 14 AM]
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`
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`ISTA Pharmaceuticals Annotmces Issuance ofU S Patent for PROLENSA(TM)
`
`From this sub-industry ......... Biotech
`Drugs
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`http://www marketwired com/press-release/ista-pharmaceuticals-annotmces-issuance-of-us-patent-for -prolensa-nasdaq-ista-1636423 htm[ 12/16/2015 11 :3 3: 14 AM]
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