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`Investor News
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`Bayer AG
`Investor Relations
`51368 Leverkusen
`Germany
`www.investor.bayer.com
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`Bayer and Regeneron start additional Phase 3 Study for VEGF
`Trap-Eye in Wet Age-related Macular Degeneration
`
`International study to evaluate efficacy and safety in treating a leading cause of blindness
`
`Leverkusen, May 8, 2008 - Bayer HealthCare AG and development partner Regeneron
`Pharmaceuticals, Inc. (NASDAQ:REGN) today announced that the first patient has been
`dosed in the new VIEW 2 trial, a second Phase 3 clinical study in a development program
`evaluating VEGF Trap-Eye for the treatment of the neovascular form of age-related
`macular degeneration (wet AMD), a leading cause of blindness in adults.
`
`VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) will enroll
`approximately 1,200 patients in up to 200 centers in Europe, Asia Pacific, Japan and
`Latin America. The first Phase 3 trial, VIEW 1, began enrolling patients in August 2007 in
`the United States and Canada. Both VIEW 1 and VIEW 2 are designed to evaluate the
`efficacy and safety of VEGF Trap-Eye administered by intravitreal injection, at dosing
`intervals of 4 and 8 weeks. The development program will include visual acuity endpoints
`and anatomical endpoints, including retinal thickness, a measure of disease activity. The
`trial is intended to establish non-inferiority of VEGF Trap-Eye with Lucentis®
`(ranibizumab) an antiangiogenic agent approved for use in wet AMD in major markets
`globally.
`
`Wet AMD accounts for about 90 percent of all severe AMD-related vision loss. It occurs
`when abnormal blood vessels in the eye leak fluid and blood into the macula, the area of
`the retina that allows for vision of fine details. This can lead to a rapid loss of central
`vision with continued progression.
`
`“Results from the Phase 2 study have shown that VEGF Trap-Eye has the potential to
`significantly reduce retinal thickness and improve vision,” said Kemal Malik, MD, Head of
`Global Development and member of the Bayer HealthCare Executive Committee. “Dosing
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`Mylan v. Regeneron, IPR2021-00880
`Page 1
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`of the first patient in this confirmatory Phase 3 trial is an important milestone for this
`compound intended to treat a devastating ocular disease that impacts millions of people
`worldwide.”
`
`“New therapies are still needed to provide optimal care to those patients with wet AMD,”
`said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research
`Laboratories. “This global Phase 3 clinical program will provide additional data to further
`evaluate the efficacy and safety of VEGF Trap-Eye using different dosing regimens.”
`
`Bayer HealthCare and Regeneron are collaborating on the global development of VEGF
`Trap-Eye for treatment of wet AMD, diabetic eye diseases, and other ocular diseases and
`disorders. Once approved, Bayer HealthCare will market VEGF Trap-Eye outside the
`U.S., where the parties will share equally in profits from any future sales of VEGF Trap-
`Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the U.S. VIEW 2 primary
`analysis results are anticipated in 2011.
`
`About VIEW 2
`In the first year, the VIEW 2 study will evaluate the safety and efficacy of VEGF Trap-Eye
`at doses of 0.5 milligrams (mg) and 2.0 mg administered at 4-week intervals and 2.0 mg
`at an 8-week dosing interval, including one additional 2.0 mg dose at week four. Patients
`randomized to the ranibizumab arm of the trial will receive a 0.5 mg dose every 4 weeks.
`After the first year of treatment, patients will continue to be followed and treated for
`another year on a flexible, criteria-based extended regimen with a dose administered at
`least every 12 weeks, but not more often than every 4 weeks until the end of the study.
`
`The primary endpoint of the study is the proportion of patients treated with VEGF Trap-
`Eye who maintain vision at the end of one year, compared to ranibizumab patients. Visual
`acuity is defined as the total number of letters read correctly on the Early Treatment
`Diabetic Retinopathy Study (ETDRS) chart, a standard chart used in research to measure
`visual acuity. Maintenance of vision is defined as losing fewer than three lines (equivalent
`to 15 letters) on the ETDRS chart. Key secondary endpoints include the mean change
`from baseline in visual acuity as measured by ETDRS and the proportion of patients who
`gained at least 15 letters of vision at week 52.
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`Mylan v. Regeneron, IPR2021-00880
`Page 2
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`Phase 2 Clinical Data
`In a Phase 2 trial in 157 patients, announced in October 2007 at the Retina Society
`Conference in Boston, VEGF Trap-Eye met both primary and secondary key endpoints: a
`statistically significant reduction in retinal thickness (a measure of disease activity) after
`12 weeks of treatment compared with baseline and a statistically significant improvement
`from baseline in visual acuity (ability to read letters on an eye chart).
`
`About VEGF Trap-Eye
`Vascular endothelial growth factor (VEGF) is a naturally occurring protein in the body
`whose normal role is to trigger the formation of new blood vessels (angiogenesis) to
`support the growth of the body’s tissues and organs. It has also been associated with the
`abnormal growth and fragility of new blood vessels in the eye, which lead to the
`development of wet AMD. VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion
`protein that binds all forms of VEGF-A along with the related placental growth factor
`(PIGF) and VEGF-B. VEGF Trap-Eye is a specific and highly potent blocker of these
`growth factors. Blockade of VEGF can prevent abnormal blood vessel formation as well
`as vascular leak and has proven beneficial in the treatment of wet AMD.
`
`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 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 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 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, Consumer Care, Diabetes Care and Pharmaceuticals
`divisions. The pharmaceuticals business operates under the name Bayer Schering
`Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will
`improve human and animal health worldwide. Find more information at
`www.bayerhealthcare.com.
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`Mylan v. Regeneron, IPR2021-00880
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`Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its
`research and business activities are focused on the following areas: Diagnostic Imaging,
`General Medicine, Specialty Medicine and Women's Healthcare. With innovative
`products, Bayer Schering Pharma aims for leading positions in specialized markets
`worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to
`medical progress and strives to improve the quality of life. Find more information at
`www.bayerscheringpharma.de.
`
`About Regeneron
`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 clinical trials for the potential treatment
`of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in
`other diseases and disorders. Additional information about Regeneron and recent news
`releases are available on Regeneron's Web site at www.regeneron.com.
`
`(Note: Lucentis® is a registered trademark of Genentech, Inc.)
`
`Bayer AG, Investor Relations contacts:
`
`Dr. Alexander Rosar (+49-214-30-81013)
`Dr. Juergen Beunink (+49-214-30-65742)
`Peter Dahlhoff (+49-214-30-33022)
`Ilia Kürten (+49-214-30-35426)
`Ute Menke (+49-214-30-33021)
`Judith Nestmann (+49-214-30-66836)
`Dr. Olaf Weber (+49-214-30-33567)
`
`
`Bayer HealthCare Forward-Looking Statement
`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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`Mylan Exhibit 1032
`Mylan v. Regeneron, IPR2021-00880
`Page 4
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`Regeneron Forward Looking Statement
`This news release discusses historical information and includes forward-looking statements about Regeneron and its
`products, development programs, finances, and business, all of which involve a number of risks and uncertainties, such
`as risks 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 collaboration agreement, including Regeneron’s agreements with the sanofi-aventis Group and Bayer HealthCare,
`to be canceled or to terminate without any product success, risks associated with third party intellectual property, and
`other material risks. 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-Q for the quarter ended
`March 31, 2008. 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.
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`Mylan Exhibit 1032
`Mylan v. Regeneron, IPR2021-00880
`Page 5
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`Joining Petitioner: Apotex
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