May 8, 2008
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`Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in
`Wet Age-Related Macular Degeneration
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`-International study to evaluate efficacy and safety in treating a leading cause of blindness
`
`Leverkusen, Germany, Montville, NJ and Tarrytown, NY, May 8, 2008 - Bayer HealthCare AG and Regeneron
`Pharmaceuticals, Inc. (NASDAQ:REGN) today announced that the first patient has been dosed in the 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 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 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) 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.
`
`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
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`Mylan Exhibit 1013
`Mylan v. Regeneron, IPR2021-00881
`Page 1
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`Joining Petitioner: Apotex
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`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).
`
`Following the initial 12-week fixed-dosing phase of the trial, patients continued to receive therapy at the same dose on a PRN
`(as needed) dosing schedule based upon the physician assessment of the need for re-treatment in accordance with pre-
`specified criteria. At the 2008 meeting of the Association for Vision and Ophthalmology (ARVO), it was reported that, on
`average, patients on the PRN dosing schedule maintained the gain in visual acuity and decrease in retinal thickness achieved
`at week 12 through week 32 of the study.
`
`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. 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.)
`
`Contact at Bayer HealthCare:
`Astrid Kranz, Phone: +49 30 468 12057
`E-mail: astrid.kranz@bayerhealthcare.com
`Rose Talarico, Phone: +1 973 305 5258
`E-mail: rose.talarico@bayer.com
`Contact at Regeneron:
`Laura Lindsay, Phone: +1 914 345 7800
`E-mail: laura.lindsay@regeneron.com
`Lauren Tortorete, Phone: +1 212 845 5609
`E-mail: ltortorete@biosector2.com
`AK (2008-0144E)
`
`Mylan Exhibit 1013
`Mylan v. Regeneron, IPR2021-00881
`Page 2
`
`Joining Petitioner: Apotex
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`

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`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.
`
`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
`forwardlooking statement, whether as a result of new information, future events, or otherwise unless required by law.
`
`Mylan Exhibit 1013
`Mylan v. Regeneron, IPR2021-00881
`Page 3
`
`Joining Petitioner: Apotex
`
`