December 20, 2010
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`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)
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`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
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`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
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`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.
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`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.
`
`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 (DME And VEGF Trap-Eye:
`INvestigation of Clinical 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
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`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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`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.
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`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.
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`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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`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.
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`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.
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`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.
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`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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`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.
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`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.
`
`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.
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`*As noted during our investor teleconference on December 20, 2010, the press release inadvertently omitted certain information, which
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`Regeneron does not consider to be material. To reflect inclusion of such omitted information, this sentence would be replaced with the
`following: "In this study, VEGF Trap-Eye was generally well-tolerated and no patients experienced ocular drug-related serious adverse
`events. With respect to the number of patients with non-ocular serious adverse events judged by investigators to be drug-related, there
`were none during the first six months of the study and one in the second six months."
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`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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