`Neovascular Age-Related Macular Degeneration (Wet AMD)
`
`September 14, 2009
`
`TARRYTOWN, N.Y., Sept 14, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today
`announced the completion of patient enrollment in 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). In each study of the VIEW (VEGF Trap-Eye: Investigation of Efficacy and
`Safety in Wet AMD) program, VEGF Trap-Eye is being evaluated for its effect on maintaining and improving vision when dosed as an intravitreal
`injection on a schedule of 0.5 milligram (mg) every four weeks, 2.0 mg every four weeks, or 2.0 mg every eight weeks (following three monthly doses),
`as compared with intravitreal ranibizumab (Lucentis((R)), a registered trademark of Genentech, Inc.) administered 0.5 mg every four weeks during the
`first year of the studies. As-needed (PRN) dosing with both agents 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 Regeneron and Bayer HealthCare AG. Each study has enrolled in excess of
`the targeted 1,200 patient goal. One-year primary endpoint data from both studies are expected in the fourth quarter of 2010.
`
`VEGF Trap-Eye, an investigational drug, is being developed by Regeneron and Bayer HealthCare AG for the potential treatment of eye diseases,
`including wet AMD, diabetic macular edema (DME), and Central Retinal Vein Occlusion (CRVO). Regeneron maintains exclusive rights to VEGF
`Trap-Eye in the United States. Bayer HealthCare has exclusive rights to market VEGF Trap-Eye outside the United States, where the companies will
`share equally in profits from any future sales of VEGF Trap-Eye.
`
`"Even with recent advances in the treatment of wet AMD, vision is not improved or stabilized in all patients despite monthly office visits and
`examinations that are inconvenient for these often elderly patients," said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research
`Laboratories. "This Phase 3 program is exploring various doses and dosing schedules with our novel anti-VEGF investigational agent to evaluate
`whether further improvements in vision and/or longer dosing intervals than monthly administration are possible."
`
`About the VIEW Program
`
`The VIEW 1 study is being conducted in the United States and Canada by Regeneron and the VIEW 2 study is being conducted in Europe, Asia
`Pacific, Japan, and Latin America by Bayer HealthCare. In the first year of the studies, the safety and efficacy of VEGF Trap-Eye at doses of 0.5 mg
`and 2.0 mg administered at four-week intervals and 2.0 mg at an eight-week dosing interval following one additional 2.0 mg dose at week four are
`being evaluated. Patients randomized to the ranibizumab arm of the trial will receive a 0.5 mg dose every four weeks. After the first year of treatment,
`patients will continue to be followed and treated for another year on a flexible, criteria-based extended PRN regimen with a dose administered at least
`every 12 weeks, but not more often than every four weeks until the end of the study.
`
`The primary endpoint of these non-inferiority studies 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.
`
`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). Investigational VEGF Trap-Eye is a specific blocker of VEGF-A and
`PlGF that has been demonstrated in preclinical models to bind these growth factors with greater affinity than their natural receptors. Blockade of VEGF
`can prevent abnormal blood vessel formation as well as vascular leak and has proven beneficial in the treatment of wet AMD.
`
`VEGF Trap-Eye is also in Phase 3 development for the treatment of Central Retinal Vein Occlusion (CRVO), another cause of blindness. 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. Patients in both studies will receive six monthly intravitreal injections of either VEGF
`Trap-Eye at a dose of 2 mg or sham control injections. The primary endpoint of both studies is improvement in visual acuity versus baseline after six
`months of treatment. At the end of the initial six months, patients will be dosed on a PRN (as needed) basis for another six months. All patients will be
`eligible for rescue laser treatment. Initial data from the program are anticipated in early 2011.
`
`VEGF Trap-Eye is also in Phase 2 development for the treatment of Diabetic Macular Edema (DME). VEGF Trap-Eye dosed at 0.5 mg or 2 mg
`monthly, 2 mg every eight weeks after three monthly loading doses, or 2 mg on an as-needed (PRN) basis after three monthly loading doses is being
`compared to focal laser treatment, the current standard of care in DME. The primary efficacy endpoint evaluation is mean improvement in visual acuity
`at six months. Patient enrollment has been completed with initial data expected in the first half of 2010.
`
`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
`
`Mylan Exhibit 1068
`Mylan v. Regeneron, IPR2021-00881
`Page 1
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`Joining Petitioner: Apotex
`
`
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`people over the age of 65 in the U.S. and Europe.
`
`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((R) )(rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has
`therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, inflammatory diseases, and pain, 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 - Regeneron Pharmaceuticals, Inc.
`
`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 VEGF Trap-Eye, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's
`ability to continue to develop or commercialize VEGF Trap-Eye, competing drugs that may be superior to VEGF Trap-Eye, uncertainty of market
`acceptance of VEGF Trap-Eye, 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, 2008 and Form 10-Q for the quarter ending June 30, 2009.
`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:(cid:10)
` Peter Dworkin Laura Lindsay(cid:10)
` Investor Relations Media Relations(cid:10)
` 914.345.7640 914.345.7800(cid:10)
` peter.dworkin@regeneron.com laura.lindsay@regeneron.com(cid:10)
`
`SOURCE Regeneron Pharmaceuticals, Inc.
`
`http://www.regeneron.com(cid:10)
`
`Copyright (C) 2009 PR Newswire. All rights reserved
`
`Mylan Exhibit 1068
`Mylan v. Regeneron, IPR2021-00881
`Page 2
`
`Joining Petitioner: Apotex
`
`