Press release, dated March 28, 2005.
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`http://www.sec.gov/Archives/edgar/data/930553/000119312505063654/...
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`EX-99.2 3 dex992.htm PRESS RELEASE, DATED MARCH 28, 2005.
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`Exhibit 99.2
`
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`Press Release
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`ISTA Pharmaceuticals Receives FDA Approval for Xibrom(TM) for the Treatment of Ocular Inflammation Following
`Cataract Surgery
`Monday March 28, 7:30 am ET
`
`
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`Source: ISTA Pharmaceuticals, Inc.
`
` -
`
` Xibrom will be ISTA’s Third Product Launched in the U.S. Market -
` IRVINE, Calif., March 28 /PRNewswire-FirstCall/ — ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News) today announced that the
`U.S. Food & Drug Administration (FDA) has approved the New Drug Application (NDA) for Xibrom(TM) (bromfenac ophthalmic
`solution) 0.09% for the treatment of ocular inflammation following cataract surgery. ISTA expects to launch Xibrom(TM), a topical,
`twice-daily, non-steroidal anti-inflammatory solution (NSAID), during the second quarter of 2005, after securing commercial
`quantities of the product from its manufacturer and completing the further expansion of its sales force.
`
`Eric Donnenfeld, M.D., Associate Professor of Ophthalmology, New York University Medical Center, New York and an investigator
`in the Xibrom Phase III clinical trials, commented, “Xibrom is the first twice-daily ophthalmic NSAID to be approved in the United
`States. All other ophthalmic NSAIDS are dosed four times daily. Xibrom represents an advance for ophthalmic care because of the
`improved patient compliance and its early onset of action, and I am pleased that patients will have this new treatment option.”
`
`Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, “We are excited to receive FDA approval of our third
`commercial product and anticipate launching Xibrom during the second quarter of 2005. We recently completed the interim expansion
`of our sales force which is now promoting Istalol(TM) and Vitrase®. With the Xibrom approval, we plan on hiring additional sales
`representatives in order to reach approximately 10,000 ophthalmologists in the U.S.”
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`There will be a conference call today with ISTA management at 10:30 a m. EDT to discuss the approval of Xibrom in further detail. If
`you would like to participate in the call, please dial (800) 665-0430 from the United States or Canada or (913) 981-5591 from outside
`North America. A playback of this call will be available today for 24 hours and may be accessed by dialing (888) 203-1112 from the
`United States or Canada or (719) 457-0820 from outside North America. The rebroadcast access code is 3204174. In addition, this
`conference call will be webcast live and subsequently archived on ISTA’s website at http://www.istavision.com.
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`ABOUT XIBROM AND THE U.S. OPHTHALMIC ANTI-INFLAMMATORY MARKET
` Xibrom (bromfenac ophthalmic solution) 0.09% is a sterile, topical, non-steroidal anti-inflammatory compound for the treatment of
`ocular inflammation following cataract surgery. Senju Pharmaceuticals Co. Ltd. has marketed this product in Japan since 2000. ISTA
`acquired U.S. marketing rights for Xibrom in May 2002 under a license from Senju. ISTA completed two pivotal Phase III clinical
`studies of Xibrom in the United States. In these studies involving 527 patients, a statistically significant proportion of patients treated
`with Xibrom achieved treatment success, defined as the complete absence of ocular inflammation, compared to those patients who
`received placebo. This effect was evident in the Xibrom group as early as Day 3 following initiation of treatment. ISTA filed its NDA
`for Xibrom with the FDA in May 2004.
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`According to company estimates and data compiled by IMS Health, the U.S. ophthalmic anti-inflammatory market, consisting of
`steroids, NSAIDS and other related products, is approximately $250 million per year.
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`SENJU EXHIBIT 2213
`LUPIN v. SENJU
`IPR2015-01100
`
`

`
`Press release, dated March 28, 2005.
`
`http://www.sec.gov/Archives/edgar/data/930553/000119312505063654/...
`
`ABOUT ISTA
` ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved
`ophthalmic products. ISTA’s products and product candidates seek to address serious diseases and conditions of the eye such as dry
`eye, vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma and inflammation. Building on this pipeline, ISTA’s goal is to
`continue its growth as a specialty pharmaceutical company by acquiring complementary products, either already marketed or in
`late-stage development. For additional information regarding ISTA, please visit ISTA Pharmaceuticals’ Website at
`http://www.istavision.com.
`
`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 regarding the timing of our expected
`commercial launch of Xibrom, our receipt of Xibrom launch quantities, or our sales force expansion plans are forward-looking
`statements. ISTA disclaims any intent or obligation to update any forward-looking statements. Such 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: risks and
`uncertainties related to the timing, scope and outcome of FDA and other governmental agency actions and decisions; uncertainties and
`risks regarding market acceptance of Xibrom, including but not limited to the impact of competitive products and pricing; uncertainties
`and risks related to ISTA’s ability to continue to sufficiently develop and expand its sales, marketing and distribution capabilities and
`properly manage its growth; uncertainties and risks related to the availability on a timely basis of third party sourced products
`(including Xibrom) on commercially reasonable terms; uncertainties and risks related to the scope, validity and enforceability of
`patents related to ISTA’s products and technologies and the impact of patents and other intellectual property rights held by third
`parties; and such 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, 2004.
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