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`EDGAR ONLINE - REGENERON PHARMACEUTICALS ... (REGN) - 8-K - 12/20/2010
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`Exhibit 99.1
`
`For Immediate Release
`Press Release
`
`Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Phase 3 Study in Central
`Retinal Vein Occlusion (CRVO) and in Phase 2 Study in Diabetic Macular Edema (DME)
`
`In Phase 3 study in CRVO, 56 percent of VEGF Trap-Eye patients gained at least 15 letters of vision compared to 12 percent in control group;
`VEGF Trap-Eye patients on average gained 17 letters of vision compared to mean loss of 4 letters in control group
`
`In Phase 2 study in DME, patients in all VEGF Trap-Eye dose groups, including VEGF Trap-Eye dosed every two months, maintained or
`increased vision gains through 52-weeks
`
`Regeneron to receive $20 million in milestone payments in connection with VEGF Trap-Eye program
`
`Tarrytown, NY, USA, and Berlin, Germany, December 20, 2010 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) and Bayer
`HealthCare today announced positive top-line results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the COPERNICUS study, which
`is led by Regeneron, the first of two Phase 3 studies in patients with macular edema due to central retinal vein occlusion (CRVO). In this trial,
`56.1 percent of patients receiving VEGF Trap-Eye 2 milligrams (mg) monthly gained at least 15 letters of vision from baseline, compared to
`12.3 percent of patients receiving sham injections (p<0.0001), the primary endpoint of the study. Patients receiving VEGF Trap-Eye 2mg
`monthly gained, on average, 17.3 letters of vision compared to a mean loss of 4.0 letters with sham injections (p<0.001), a secondary endpoint.
`The second Phase 3 study, GALILEO, is currently ongoing and is led by Bayer HealthCare.
`
`VEGF Trap-Eye was generally well tolerated and the most common adverse events were those typically associated with intravitreal injections or
`the underlying disease. A total of 114 patients were randomized to receive VEGF Trap-Eye and 73 patients to the control arm. Serious ocular
`adverse events in the VEGF Trap-Eye group were uncommon (3.5%) and were more frequent in the control group (13.5%). The incidence of
`non-ocular serious adverse events was generally well-balanced between the treatment arms. There were no deaths among the 114 patients
`treated with VEGF Trap-Eye and two in the 73 (2.7%) patients treated with sham injections.
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`“In the COPERNICUS trial, patients treated with VEGF Trap-Eye experienced a marked improvement in vision,” said George D. Yancopoulos,
`M.D., Ph.D., President of Regeneron Research Laboratories. “If these results are confirmed by data from the GALILEO study, expected in the
`second quarter of 2011, VEGF Trap-Eye could provide patients and physicians with a new treatment option for central retinal vein occlusion.”
`
`“After reporting positive results from our global Phase 3 program (VIEW 1 and VIEW 2 studies) for the treatment of the neovascular form of
`age related macular degeneration (wet AMD), we are pleased to also have a positive Phase 3 trial with VEGF Trap-Eye in central retinal vein
`occlusion, a potential second indication,” said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive
`Committee. “We are working diligently with Regeneron to prepare regulatory filings for VEGF Trap-Eye in wet AMD to submit in the first half
`of 2011.”
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`Detailed results for COPERNICUS will be presented at the Angiogenesis Conference in Miami, Florida in February 2011.
`
`Regeneron will receive a $10 million milestone payment from Bayer HealthCare in connection with the COPERNICUS trial meeting its
`primary endpoint and received a $10 million milestone payment in December 2010 for the positive VIEW 1 and VIEW 2 trial results in wet
`AMD.
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`Phase 2 DME Results
`Regeneron and Bayer HealthCare also reported 52 week follow-up results from the Phase 2 DA VINCI study in patients with diabetic macular
`edema (DME). In this study, the previously reported visual acuity gains achieved with VEGF Trap-Eye treatment over 24 weeks (the primary
`endpoint of the study) were maintained or numerically improved up to completion of the study at week 52 in all VEGF Trap-Eye study groups,
`including 2mg dosed every other month. Based on these positive results, Regeneron and Bayer HealthCare are discussing plans to initiate Phase
`3 studies.
`
`In this double-masked, prospective, randomized, multi-center Phase 2 trial, entitled DA VINCI ( D ME A nd V EGF Trap-Eye: IN vestigation
`of C linical Impact), 221 patients with clinically significant DME with central macular involvement were randomized and 219 patients were
`treated with balanced distribution over five groups. The control group received macular laser therapy at baseline, and patients were eligible for
`repeat laser treatments, but no more frequently than at 16 week intervals. Two groups received monthly doses of 0.5 or 2mg of VEGF Trap-Eye
`throughout the 12-month dosing period. Two groups received three initial monthly doses of 2mg of VEGF Trap-Eye (at baseline and weeks 4
`and 8), followed through week 52 by either every two months dosing or PRN (as-needed) dosing with very strict repeat dosing criteria. Mean
`gains in visual acuity versus baseline were as follows:
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`n
`Mean change in visual acuity at
`week 24 versus baseline 1 (letters)
`Mean change in visual acuity at
`week 52 versus baseline (letters)
`*Following 3 initial monthly doses
`**p<0.01 versus laser
`1 Primary endpoint
`
`2mg
`2mg
`2mg
`Laser 0.5mg
`monthlymonthlyevery two PRN*
`months*
`45
`42
`8.5** 10.3**
`
`44
`44
`8.6** 11.4**
`
`44
`2.5
`
`-1.3 11.0** 13.1**
`
`9.7** 12.0**
`
`No significant differences among the VEGF Trap-Eye arms were observed. Approximately 80 percent of the VEGF Trap-Eye patients and 75
`percent of the laser patients remained in the study through 52 weeks.
`
`VEGF Trap-Eye was generally well-tolerated, and there were no ocular or non-ocular drug-related serious adverse events reported in the study.
`The most common adverse events reported were those typically associated with intravitreal injections or the underlying disease. The most
`frequent ocular adverse events reported among patients receiving VEGF Trap-Eye included conjunctival hemorrhage, eye pain, ocular redness
`(hyperemia), and increased intraocular pressure. The incidence of non-ocular serious adverse events was generally well balanced between all
`treatment arms. There were six deaths (3.4%) among the 175 patients treated with VEGF Trap-Eye and one (2.3%) in the 44 patients treated
`with laser over 12 months.
`
`Detailed results for DA VINCI will be presented at the Angiogenesis Conference in Miami, Florida in February 2011.
`
`About the Phase 3 CRVO Program
`Patients in the COPERNICUS (Controlled Phase 3 Evaluation of Repeated intravitreal administration of VEGF Trap-Eye In Central retinal vein
`occlusion: Utility and Safety) and the identical GALILEO (General Assessment Limiting Infiltration of Exudates in central retinal vein
`Occlusion with VEGF Trap-Eye) studies receive six monthly injections of either VEGF Trap-Eye at a dose of 2mg or sham injections. Patients
`in the COPERNICUS trial were randomized in a 3:2 ratio with 114 patients randomized to receive VEGF Trap-Eye and 73 randomized to the
`control arm. At the end of the initial six months, all patients randomized to VEGF Trap-Eye are dosed on a PRN (as needed) basis for another
`six months. In the COPERNICUS trial, patients randomized to sham injections in the first six months are eligible to cross over to VEGF Trap-
`Eye PRN dosing in the second six months. During the second six months of the studies, all patients are eligible for rescue laser treatment. Visual
`acuity was measured as a score based on the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS)
`eye chart, a standard chart used in research to measure visual acuity.
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`EDGAR ONLINE - REGENERON PHARMACEUTICALS ... (REGN) - 8-K - 12/20/2010
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`About Central Retinal Vein Occlusion (CRVO)
`Over 100,000 people in the United States and more than 66,000 people in key European countries are estimated to suffer from CRVO. CRVO is
`caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina. This causes retinal injury and loss of
`vision. The retina can also become "ischemic" (starved for oxygen), resulting in the growth of new, inappropriate blood vessels that can cause
`further vision loss and more serious complications. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular
`permeability in the eye and inappropriate new vessel growth. It is believed that anti-VEGF treatment may help decrease vascular permeability
`and edema and prevent the inappropriate growth of new blood vessels in the retina in patients with CRVO.
`
`About Diabetic Macular Edema (DME)
`DME is the most prevalent cause of moderate vision loss in patients with diabetes. DME is a common complication of Diabetic Retinopathy
`(DR), a disease affecting the blood vessels of the retina. Clinically significant DME is a leading cause of blindness in younger adults (under 50).
`Clinically significant DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp,
`direct vision. Fluid in the macula can cause severe vision loss or blindness.
`
`Approximately 370,000 Americans currently suffer from clinically significant DME, with 95,000 new cases arising each year. According to the
`American Diabetes Association, more than 18 million Americans currently suffer from diabetes, and many other people are at risk for
`developing diabetes. With the incidence of diabetes steadily climbing, it is projected that up to 10 percent of all patients with diabetes will
`develop DME during their lifetime.
`
`About VEGF Trap-Eye
`VEGF Trap-Eye is a fully human fusion protein, consisting of soluble VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the
`related Placental Growth Factor (PlGF). VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. VEGF Trap-Eye is
`specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
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`EDGAR ONLINE - REGENERON PHARMACEUTICALS ... (REGN) - 8-K - 12/20/2010
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`Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye for the treatment of the neovascular form of
`age related macular degeneration (wet AMD), diabetic macular edema (DME), central retinal vein occlusion (CRVO), and other eye diseases
`and disorders. In November 2010, Regeneron and Bayer HealthCare announced positive top-line results from two parallel Phase 3 studies
`in patients with wet AMD, VIEW 1 and VIEW 2. In these trials, all regimens of VEGF Trap-Eye, including VEGF Trap-Eye dosed every two
`months, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month. The primary endpoint
`was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab. A
`generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The incidence of ocular treatment emergent adverse
`events was balanced across all four treatment groups in both studies. There were no notable differences in non-ocular adverse events among the
`study arms. Bayer HealthCare and Regeneron are planning to submit regulatory applications for marketing approval for the treatment of wet
`AMD in Europe and the U.S. in the first-half of 2011.
`
`Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future
`sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.
`
`About Regeneron Pharmaceuticals
`Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious
`medical conditions. In addition to ARCALYST ® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has
`therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and
`central retinal vein occlusion), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for
`creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory
`conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news
`releases are available on Regeneron’s web site at www.regeneron.com .
`
`About Bayer HealthCare
`The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare,
`a subgroup of Bayer AG with annual sales of more than EUR 15.9 billion (2009), is one of the world’s leading, innovative companies in the
`healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal
`Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will
`improve human and animal health worldwide. Bayer HealthCare has a global workforce of 53.400 employees and is represented in more than
`100 countries. Find more information at www.bayerhealthcare.com.
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`EDGAR ONLINE - REGENERON PHARMACEUTICALS ... (REGN) - 8-K - 12/20/2010
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`Regeneron Forward Looking Statement
`This news release includes forward-looking statements about Regeneron and its products, development programs, finances, and business, all of
`which involve a number of risks and uncertainties. These include, among others, risks and timing associated with preclinical and clinical
`development of Regeneron's drug candidates, determinations by regulatory and administrative governmental authorities which may delay or
`restrict Regeneron's ability to continue to develop or commercialize its product and drug candidates, competing drugs that are superior to
`Regeneron's product and drug candidates, uncertainty of market acceptance of Regeneron's product and drug candidates, unanticipated
`expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any license or
`collaboration agreement, including Regeneron's agreements with Astellas, the sanofi-aventis Group and Bayer HealthCare, to be canceled or
`terminated without any product success, and risks associated with third party intellectual property. A more complete description of these and
`other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission (SEC), including its Form
`10-K for the year ended December 31, 2009 and Form 10-Q for the quarter ended September 30, 2010. Regeneron does not undertake any
`obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, unless required
`by law.
`
`Bayer Forward-Looking Statements
`This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup
`management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future
`results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in
`Bayer’s public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update
`these forward-looking statements or to conform them to future events or developments.
`
`###
`
`Your Contact at Bayer :
`Doreen Schroeder, Tel. +49 30 468-11399
`E-Mail: doreen.schroeder@bayer.com
`
`Your Investor Relations Contact at Regeneron :
`Michael Aberman, M.D. Tel. +1 (914) 345-7799
`E-Mail: michael.aberman@regeneron.com
`
`Your Media Contact at Regeneron :
`Peter Dworkin, Tel. +1 (914) 345-7640
`E-Mail: peter.dworkin@regeneron.com
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