July 11, 2007
`
`Opko Health Initiates Phase 3 Trial of
`Bevasiranib for the Treatment of AMD
`-Trial Designed to Compare Efficacy of Bevasiranib Administered Every
`8 Weeks or 12 Weeks with Lucentis(R) Administered Every 4 Weeks-
`
`-Represents First-Ever Phase 3 Pivotal Trial of an RNAi Therapeutic-
`
`MIAMI, July 11 /PRNewswire-FirstCall/ -- Opko Health Inc. (Amex: OPK) today announced
`the initiation of the Phase 3 COBALT (Combining Bevasiranib And Lucentis Therapy) clinical
`trial of bevasiranib for the treatment of wet age-related macular degeneration (wet AMD.)
`The multi-national COBALT study is currently open and enrolling patients. The trial will
`include more than 330 wet AMD patients and will assess whether bevasiranib administered
`every 8 or 12 weeks is safe and has equivalent efficacy in preventing vision loss as
`Genentech's Lucentis(R) administered every four weeks.
`
`Bevasiranib is a first-in-class small interfering RNA (siRNA) drug designed to silence the
`genes that produce vascular endothelial growth factor (VEGF), believed to be largely
`responsible for the vision loss of wet AMD. Bevasiranib is the first therapy based on the
`Nobel Prize-winning RNA interference (RNAi) technology to advance to Phase 3 clinical
`trials.
`
`"This first-ever Phase 3 trial of an agent based on RNAi technology is an important milestone
`in this new field. We are proud of the ability demonstrated by our clinical group to have
`successfully moved this innovative compound through development rapidly and cost
`effectively," said Philip Frost, M.D., Chairman and CEO of Opko Health. "Currently patients
`with wet AMD undergo intravitreal injections every four weeks to achieve the vision-
`preserving benefits of Lucentis, so the potential ability of bevasiranib to achieve similar
`results while requiring less frequent injections would be an important benefit for these
`patients who often have limited mobility."
`
`"Bevasiranib's demonstrated safety profile, its ability to inhibit the growth of the retinal lesions
`associated with wet AMD and its potential for prolonged duration are a promising foundation
`for this pivotal trial," said Lawrence Singerman M.D., founder and Executive Secretary of the
`Macula Society, Clinical Professor of Ophthalmology at Case University and a Principal
`Investigator for the Phase 3 study. "Bevasiranib's potential to serve as a long-term
`maintenance therapy for wet AMD could provide important benefits to patients, and I look
`forward to helping to assess its utility in this groundbreaking study."
`
`"We are very pleased at the enthusiastic reception the COBALT trial has received from
`retinal centers around the globe," said Denis O'Shaughnessy, Ph.D., Senior Vice President
`of Clinical Development at Opko. "Retinal physicians are keenly aware of the burden that
`frequent drug injections places on elderly patients and their families, and they are eager to
`help test an innovative new approach that has the potential to significantly reduce that
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2130 Page 1
`
`

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`burden while preserving patients' vision."
`
`About Wet AMD
`
`Wet age-related macular degeneration is the leading cause of irreversible vision loss in the
`developed world and its incidence is growing rapidly. Advanced age is the main risk factor
`for wet AMD, and it is expected to become an increasingly common condition as the
`population grows older. An estimated 1.65 million Americans have wet AMD today and an
`estimated 11 million people worldwide will have AMD by 2013. Until recently, treatments for
`wet AMD were of limited efficacy. In the search for more effective treatments, researchers
`targeted VEGF, shown to be a key cause of the excess growth and leakiness of ocular blood
`vessels that result in loss of vision in these patients. Current VEGF antagonists, such as
`Lucentis, slow this vision loss, but require injections into the eye every four weeks, a
`particular issue for elderly patients who often have limited mobility.
`
`For more information about COBALT bevasiranib clinical sites currently open and enrolling
`patients, please visit www.opko.com/clinicaltrials
`
`About Opko Health, Inc.
`
`Miami-based Opko is a specialty healthcare company. Its lead investigational drug, the
`pioneering gene silencing agent bevasiranib, has entered a pivotal Phase 3 trial after
`successfully completing Phase 2 trials for wet age-related macular degeneration and
`macular degeneration. Opko is developing a preclinical pipeline of novel agents for
`ophthalmic diseases, and it also intends to market diagnostic systems that complement its
`therapeutic products. The company recently announced it has entered into an agreement to
`acquire Ophthalmic Technologies, Inc. (OTI), a provider of innovative patient imaging
`systems to eye care professionals worldwide.
`
`This press release contains "forward-looking statements," as that term is defined under the
`Private Securities Litigation Reform Act of 1995 (PSLRA), regarding product development
`efforts and other non-historical facts 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, including the risks that enrollment of patients for the
`Phase 3 clinical trial for bevasiranib, may not be successful, that the Phase 3 clinical trial
`itself may not be completed on a timely basis or at all, that any of our compounds under
`development, including bevasiranib, may fail, may not achieve the expected results or
`effectiveness and may not generate data that would support the approval or marketing of
`products for the indications being studied or for other indications. 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. We do not undertake any obligation to
`update forward-looking statements. We intend that all forward-looking statements be subject
`to the safe-harbor provisions of the PSLRA.
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2130 Page 2
`
`

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` Contacts: Media:
` Corporate: GendeLLindheim BioCom Partners
` Steven D. Rubin Barbara Lindheim
` 305 575 6015 212 918-4650
`
`SOURCE Opko Health Inc.
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2130 Page 3
`
`