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`Opko Health, Inc.
`Announces Update on
`Phase III Clinical Trial of
`Bevasiranib; Company
`Decided to Terminate
`Clinical Study
`
`Published: Mar 06, 2009
`
`MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE
`Alternext US:OPK)today announced that, following the
`recommendation of the Independent Data Monitoring
`Committee (IDMC), it had decided to terminate its
`Phase III clinical study of Bevasiranib, a first-in-class
`siRNA, for the treatment of wet age-related macular
`degeneration (wet-AMD). Although preliminary data,
`needing further analysis, show activity of Bevasiranib
`when used adjunctively with Genentech’s Lucentis®,
`review of the data by the IDMC indicated that the trial,
`as structured, was unlikely to meet its primary end
`point. There were no systemic safety issues identified
`and local ocular safety was generally unremarkable.
`
`“While we are clearly disappointed with the
`preliminary results of this fully-enrolled study,
`the indications of activity are encouraging and
`we look forward to fully analyzing the data in
`the coming weeks,” said Dr. Phillip Frost,
`Chairman and CEO of OPKO Health. “We
`remain committed to the continued
`development of our siRNA portfolio targeting
`Vascular Endothelial Growth Factor (VEGF),
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2129 Page 1
`
`
`
`including our recently announced VEGFA165b
`sparing siRNA.” These new proprietary siRNA's
`are designed to inhibit the angiogenic Vascular
`Endothelial Growth Factor A165 (VEGFA165
`isoform) but spare the anti angiogenic
`VEGFA165b isoform.
`
`VEGFA165 is known to play a critical role in
`diseases of the eye where the underlying
`cause of the problem is abnormal growth of
`blood vessels, such as in wet age-related
`macular degeneration. To the contrary, data
`show that VEGFA165b is an inhibitor of
`abnormal vessel growth.
`
`About OPKO Health, Inc.
`
`Miami-based OPKO is a specialty healthcare
`company engaged in the development,
`marketing, and sales of novel agents and both
`diagnostic and therapeutic devices for the
`management of ophthalmic diseases. For more
`information visit the company's website at
`www.opko.com.
`
`This press release contains "forward-looking
`statements," as that term is defined under the
`Private Securities Litigation Reform Act of 1995
`(PSLRA), which statements may be identified by
`words such as "expects," "plans," "projects,"
`"will," "may," "anticipates," "believes," "should,"
`"intends," "estimates," and other words of
`similar meaning, including statements
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2129 Page 2
`
`
`
`regarding preliminary data, our product
`development efforts, our ability to significantly
`improve clinical outcomes in patients, and our
`ability to develop a preclinical pipeline of novel
`agents for ophthalmic diseases, as well as
`other non-historical statements about our
`expectations, beliefs or intentions regarding
`our business, technologies and products,
`financial condition, strategies or prospects.
`Many factors could cause our actual activities
`or results to differ materially from the activities
`and results anticipated in forward-looking
`statements. These factors include those
`described in our filings with the Securities and
`Exchange Commission, as well as risks inherent
`in funding, developing and obtaining regulatory
`approvals of new, commercially viable and
`competitive products and treatments. In
`addition, forward looking statements may also
`be adversely affected by general market
`factors, competitive product development,
`product availability, federal and state
`regulations and legislation, the regulatory
`process for new products and indications,
`manufacturing issues that may arise, patent
`positions and litigation, among other factors.
`The forward looking statements contained in
`this press release speak only as of the date the
`statements were made, and we do not
`undertake any obligation to update forward
`looking statements. We intend that all forward-
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2129 Page 3
`
`
`
`looking statements be subject to the safe-
`harbor provisions of the PSLRA.
`
`Contact: OPKO Health, Inc., Miami Steven D.
`Rubin, 305-575-6000
`
`
`
`
`
`
`✉ F T L 𝓟 r
`
`◄ Back to news
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2129 Page 4
`
`
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