Regeneron and Bayer HealthCare Announce VEGF Trap-Eye Achieved Durable Improvement in
`Vision over 52 Weeks in a Phase 2 Study in Patients with Age-related Macular Degeneration
`
`August 19, 2008
`Regeneron and Bayer HealthCare Announce VEGF Trap-Eye Achieved Durable Improvement in Vision over 52 Weeks in a Phase
`2 Study in Patients with Age-related Macular DegenerationTarrytown, NY and Leverkusen, Germany (August 19, 2008) –
`Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare AG today announced that patients with wet age-related
`macular degeneration (AMD) receiving VEGF Trap-Eye in a Phase 2 extension study on a PRN (as needed) dosing schedule
`continued to show highly significant improvements at 52 weeks in the primary and key secondary endpoints of retinal thickness
`(an anatomic measure of treatment effect) and vision gain.  The 12-week primary endpoint results from the fixed-dosing period of
`the study were presented at the 2007 Retina Society conference in September 2007.  The 32-week results of the Phase 2 study
`were presented at the 2008 Association for Research in Vision and Ophthalmology (ARVO) meeting in Fort Lauderdale, Florida in
`April 2008.  A full analysis of the 52-week results of the Phase 2 study will be presented at the 2008 meeting of the Retina Society
`on September 26-28, 2008 in Scottsdale, Arizona.
`
`In this double-masked, prospective, randomized, multi-center Phase 2 trial, 157 patients were randomized to five dose groups and treated with VEGF
`Trap-Eye in one eye.  Two groups initially received monthly doses of 0.5 or 2.0 milligrams (mg) of VEGF Trap-Eye (at weeks 0, 4, 8, and 12) and three
`groups received quarterly doses of 0.5, 2.0, or 4.0 mg of VEGF Trap-Eye (at baseline and week 12).  Following the initial 12-week fixed-dosing phase
`of the trial, patients continued to receive therapy at the same dose on a PRN dosing schedule based upon the physician assessment of the need for
`re-treatment in accordance with pre-specified criteria.  Patients were monitored for safety, retinal thickness, and visual acuity.  These data represent
`the final one-year analysis from the 52-week study.
`
`Patients receiving four monthly doses of VEGF Trap-Eye, either 2.0 or 0.5 mg, for 12 weeks followed by PRN dosing thereafter, achieved mean
`improvements in visual acuity versus baseline of 9.0 letters (p<0.0001) and 5.4 letters (p=0.085), respectively, and mean decreases in retinal
`thickness versus baseline of 143 microns (p<0.0001) and 125 microns (p<0.0001) at week 52, respectively.  During the subsequent PRN dosing
`phase, patients initially dosed on a 2.0 mg monthly schedule received, on average, only 1.6 additional injections and those initially dosed on a 0.5 mg
`monthly schedule received, on average, 2.5 injections.
`
`For all dose cohorts combined, there was a 5.3 mean letter gain in visual acuity versus baseline at the week 52 evaluation visit (p<0.0001).  The mean
`decrease in retinal thickness for all dose groups combined at week 52 was 130 microns versus baseline (p<0.0001).  During the week 12 to week 52
`PRN dosing period, patients from all dose groups combined received, on average, only two additional injections.
`
`VEGF Trap-Eye was generally well tolerated and there were no drug-related serious adverse events.  There was one reported case of culture-negative
`endophthalmitis/uveitis in the study eye and one arterial thrombotic event, neither of which was deemed to be drug-related.  The most common
`adverse events were those typically associated with intravitreal injections.
`
`"Based upon retinal physicians’ feedback, there remains a significant unmet medical need for a treatment for wet AMD that can reliably improve visual
`acuity over time without the need for monthly intravitreal injections,” said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research
`Laboratories.  “We are excited about these study findings and the potential for VEGF Trap-Eye to fulfill this need pending the results of our ongoing
`Phase 3 clinical studies.”
`
`“The 52-week results underline that VEGF Trap-Eye has the potential to significantly reduce retinal thickness and improve vision,” said Dr. Kemal
`Malik, member of the Bayer HealthCare Executive Committee responsible for product development.  “The further development of this compound is
`important for millions of people worldwide who suffer from this devastating ocular disease.”
`
`About the Phase 3 Program in Wet AMD
`Regeneron and Bayer HealthCare initiated a Phase 3 global development program for VEGF Trap-Eye in wet AMD in August 2007. In two Phase 3
`trials, VIEW 1 and VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet Age-related Macular Degeneration), the companies are
`evaluating VEGF Trap-Eye dosed 0.5 mg every 4 weeks, 2 mg every 4 weeks, or 2 mg every 8 weeks (following three monthly doses) in direct
`comparison with ranibizumab (Lucentis®, a registered trademark of Genentech, Inc.) administered 0.5 mg every four weeks according to its U.S. label
`during the first year of the studies.  PRN dosing will be evaluated during the second year of each study.  The VIEW1 study (http://www.regeneron.com
`/vegftrap_eye.html) is currently enrolling patients in the United States and Canada and the VIEW2 study (www.view2study.com) is currently enrolling
`patients in Europe, Asia Pacific, Japan, and Latin America.  The companies are collaborating on the global development of VEGF Trap-Eye for the
`treatment of wet AMD, diabetic eye diseases, and other eye diseases and disorders.  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 VEGF Trap-Eye
`Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger 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.  The 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 (PlGF).  VEGF Trap-Eye is a specific and highly potent blocker of these growth
`factors.  Blockade of VEGF, which can prevent abnormal blood vessel formation and vascular leak, has proven beneficial in the treatment of wet AMD.
`
`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00881
`Page 1
`
`Joining Petitioner: Apotex
`
`

`

`About Wet AMD
`Age-related Macular Degeneration (AMD) is a leading cause of acquired blindness.  Macular degeneration is diagnosed as either dry (nonexudative)
`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 Regeneron Pharmaceuticals, Inc.
`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.
`
`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-K for the year ended December 31, 2007 and Form
`10-Q for the quarter ending June 30, 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.
`
`Contact Information:
`
`Regeneron Pharmaceuticals, Inc.
`Investor Relations                                                     
`914-345-7640                                                          
`invest@regeneron.com                   
`
`Laura Lindsay
`Corporate Communications
`914-345-7800
`laura.lindsay@regeneron.com
`
`Lauren Tortorete
`Media Relations
`212-845-5609
`ltortorete@biosector2.com
`
`Bayer HealthCare
`Astrid Kranz
`+49 30 468-12057
`astrid.kranz@bayerhealthcare.com
`
` 
`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00881
`Page 2
`
`Joining Petitioner: Apotex
`
`