`Age-Related Macular Degeneration
`
`May 8, 2008
`Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular
`DegenerationLeverkusen, 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 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
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`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)
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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.
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