4/6/23, 10:14 PM
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`EDGAR ONLINE - REGENERON PHARMACEUTICALS ... (REGN) - 8-K - 11/22/2010
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`Exhibit 99.1
`
`For Immediate Release
`
`Press Release
`Bayer and Regeneron Report Positive Top-Line Results of Two Phase 3 Studies with VEGF Trap-Eye in Wet Age-related Macular
`Degeneration
`In both studies, all regimens of VEGF Trap-Eye, including VEGF Trap-Eye dosed every two months, achieved primary endpoint compared
`to ranibizumab dosed every month
`Regulatory applications for marketing approval planned in first-half of 2011
`Tarrytown, NY, USA, and Berlin, Germany, November 22, 2010 — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) and Bayer
`HealthCare today announced that in two parallel Phase 3 studies in patients with the neovascular form of age-related macular degeneration
`(wet AMD), all regimens of VEGF Trap-Eye (aflibercept ophthalmic solution), 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.
`Further results will be presented at the Angiogenesis Conference in February 2011. Bayer HealthCare and Regeneron are planning to submit
`regulatory applications for marketing approval in Europe and the U.S. in the first-half of 2011 based on the positive results of the VIEW 1
`and VIEW 2 trials.
`In the North American VIEW 1 study, 96 percent of patients receiving VEGF Trap-Eye 0.5mg monthly, 95 percent of patients receiving
`VEGF Trap-Eye 2mg monthly, and 95 percent of patients receiving VEGF Trap-Eye 2mg every two months achieved maintenance of vision
`compared to 94 percent of patients receiving ranibizumab 0.5mg dosed every month. In the international VIEW 2 study, 96 percent of
`patients receiving VEGF Trap-Eye 0.5mg monthly, 96 percent of patients receiving VEGF Trap-Eye 2mg monthly, and 96 percent of
`patients receiving VEGF Trap-Eye 2mg every two months achieved maintenance of vision compared to 94 percent of patients receiving
`ranibizumab 0.5mg dosed every month. 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
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`visual acuity, over 52 weeks. Maintenance of vision was defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS eye
`chart.
`“The currently available anti-VEGF therapies have significantly advanced the treatment of wet AMD, actually improving vision in many
`patients. However, monthly injections are required to optimize and maintain vision gain over the long-term.” said Ursula Schmidt-Erfurth,
`M.D., Professor and Chair of the Department of Ophthalmology at the University Eye Hospital in Vienna, Austria and the VIEW 2 Principal
`Investigator. “The results of the VIEW studies indicate that VEGF Trap-Eye could establish a new treatment paradigm for the management
`of patients with wet AMD — predictable every-other-month dosing without the need for intervening monitoring or dosing visits.”
`“In an effort to avoid the inconvenience of monthly office visits and the burden of monthly injections into the eye for their wet AMD
`patients, retinal specialists have tried to extend the benefits of the existing anti-VEGF therapy with less frequent dosing. A growing body of
`data suggests that this practice may result in inconsistent visual acuity outcomes,” said Jeffrey Heier, M.D., a clinical ophthalmologist and
`retinal specialist at Ophthalmic Consultants of Boston, Assistant Professor of ophthalmology at Tufts School of Medicine, and Chair of the
`Steering Committee for the VIEW 1 trial. “A critical goal of these studies was to demonstrate that VEGF Trap-Eye could achieve robust
`improvements in vision and maintain them over time with a more convenient every-other-month dose. Achievement of this goal could be
`important for patients, care givers, and physicians.”
`In the VIEW 1 study, patients receiving VEGF Trap-Eye 2mg monthly achieved a statistically significant greater mean improvement in
`visual acuity at week 52 versus baseline (secondary endpoint), compared to ranibizumab 0.5mg monthly; patients receiving VEGF Trap-Eye
`2mg monthly on average gained 10.9 letters, compared to a mean 8.1 letter gain with ranibizumab 0.5mg dosed every month (p<0.01). All
`other dose groups of VEGF Trap-Eye in the VIEW 1 study and all dose groups in the VIEW 2 study were not statistically different from
`ranibizumab in this secondary endpoint.
`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, with the most frequent events associated with the injection
`procedure, the underlying disease, and/or the aging process. The most frequent ocular adverse events were conjunctival hemorrhage,
`macular degeneration, eye pain, retinal hemorrhage, and vitreous floaters. The most frequent serious non-ocular adverse events were typical
`of those reported in this elderly population who receive intravitreal treatment for wet AMD; the most frequently reported events were falls,
`pneumonia, myocardial infarction, atrial fibrillation, breast cancer, and acute coronary syndrome. There were no notable differences among
`the study arms.
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`In the second year of the studies, patients in VIEW 1 and VIEW 2 will continue to be treated with the same dose per injection as in the first
`year but administered only every three months, or more often for any worsening of AMD, based on protocol-defined criteria (called
`“quarterly capped PRN” dosing).
`
`About the VIEW Program
`The VIEW (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) program consists of two randomized, double-masked,
`Phase 3 clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD).
`The VIEW 1 study, which randomized 1217 patients, is being conducted in the United States and Canada by Regeneron under a Special
`Protocol Assessment (SPA) with the U.S. Food and Drug Administration. The VIEW 2 study, which randomized 1240 patients, is being
`conducted in Europe, Asia Pacific, Japan, and Latin America by Bayer HealthCare. The study designs are essentially identical. The primary
`endpoint evaluation was conducted at 52 weeks.
`In each of the studies, VEGF Trap-Eye was evaluated for its effect on maintaining and improving vision when dosed as an intravitreal
`injection on a schedule of 0.5mg monthly, 2mg monthly, or 2mg every two months (following three monthly loading doses), as compared
`with intravitreal ranibizumab administered 0.5mg every month during the first year of the studies. As-needed (PRN) dosing with both
`agents, with a dose administered at least every three months (but not more often than monthly), is being evaluated during the second year of
`each study. These studies are part of the global development program for VEGF Trap-Eye being conducted by Bayer HealthCare and
`Regeneron.
`The primary endpoint of these non-inferiority studies is the proportion of patients treated with VEGF Trap-Eye who maintain visual acuity at
`the end of one year, compared to ranibizumab patients. Visual acuity is 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,
`over 52 weeks. Maintenance of vision is defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS chart.
`The following table summarizes the VIEW 1 and VIEW 2 results for the primary and the first secondary endpoint pre-specified for testing:
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`VEGF Trap-Eye
`Ranibizumab
`0.5mg monthly
`0.5mg monthly
`Maintenance of vision* (% patients losing <15 letters) at week 52 versus baseline
`95.1%**
`VIEW 1
`94.4%
`95.9%**
`95.6%**
`VIEW 2
`94.4%
`96.3%**
`Mean improvement in vision* (letters) at 52 weeks versus baseline (p-value versus ranibizumab 0.5mg monthly)***
`VIEW 1
`8.1
`6.9 (NS)
` 10.9 (p<0.01)
`VIEW 2
`9.4
`9.7 (NS)
`7.6 (NS)
`
`VEGF Trap-Eye
`2mg monthly
`
`VEGF Trap-Eye
`2mg every 2
`months
`
`95.1%**
`95.6%**
`
`7.9 (NS)
`8.9 (NS)
`
`*
`
`Visual acuity was measured as the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study
`(ETDRS) eye chart
`** Statistically non-inferior based on a non-inferiority margin of 10%, using confidence interval approach (95.1% and 95% for VIEW 1
`and VIEW 2, respectively)
`*** Test for superiority
`NS=non-significant
`
`About Wet AMD
`Age-related Macular Degeneration (AMD) is a leading cause of acquired blindness. Macular degeneration is diagnosed as either dry (non-
`exudative) or wet (exudative). In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes
`disruption and dysfunction of the retina creating distortion and/or blind spots in central vision, and it can account for blindness in wet AMD
`patients. Wet AMD is the leading cause of blindness for people over the age of 65 in the U.S. and Europe.
`
`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.
`VEGF Trap-Eye is also in Phase 3 development for the treatment of Central Retinal Vein Occlusion (CRVO), another major cause of
`blindness, in two identical studies. The COPERNICUS (COntrolled Phase 3 Evaluation of Repeated iNtravitreal administration of VEGF
`Trap-Eye In Central retinal vein occlusion: Utility and Safety) study is being led by Regeneron and the GALILEO (General Assessment
`Limiting InfiLtration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) study is being led by Bayer HealthCare. The
`primary endpoint of both studies is improvement in visual acuity versus baseline after six months of treatment. Initial data from the CRVO
`program are anticipated in early 2011.
`VEGF Trap-Eye is also in Phase 2 development for the treatment of Diabetic Macular Edema (DME). In February 2010, Regeneron and
`Bayer HealthCare announced that treatment with VEGF Trap-Eye in the Phase 2 DA VINCI (DME And VEGF Trap-Eye: INvestigation of
`Clinical Impact) study demonstrated a statistically significant improvement in visual acuity versus baseline after six months of treatment
`compared to focal laser therapy, the primary endpoint of the study. Initial one-year results from this trial will be available before the end of
`this year.
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`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 healthcare, nutrition and high-tech materials. Bayer
`HealthCare, a subsidiary of Bayer AG, 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, Bayer Schering Pharma, Consumer
`Care and Medical Care divisions. Bayer HealthCare’s aim is to discover, manufacture and market products that will improve human and
`animal health worldwide. Find more information at www.bayerhealthcare.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.
`Your Contact at Bayer :
`Doreen Schroeder, Tel. +49 30 468-11399
`E-Mail: doreen.schroeder@bayer.com
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`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
`
`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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