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EYLEA™ (aflibercept Injection) Submitted In Japan For Marketing Authorization For The Treatment Of Wet Age-Related Macular Degeneration


EYLEA is a fully human fusion protein, consisting of portions of VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF).  EYLEA is a specific and highly potent blocker of these growth factors.  EYLEA is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.

Regeneron and Bayer HealthCare are collaborating on the global development of EYLEA with Phase 3 programs for the treatment of the neovascular form of age-related macular degeneration (wet AMD), central retinal vein occlusion (CRVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV).

Regeneron submitted a Biologics License Application (BLA) for marketing approval in wet AMD in the U.S. in February 2011 and received a Priority Review designation.  Under Priority Review, the target date for an FDA decision on the EYLEA BLA is August 20, 2011.  Bayer HealthCare submitted an application for marketing authorization in Europe in June 2011.

About Regeneron Pharmaceuticals

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 Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration, central retinal vein occlusion, and diabetic macular edema), and certain cancers.  Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer.  Additional information about Regeneron and recent news releases are available on Regeneron's web site at

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 subgroup of Bayer AG with annual sales of more than EUR 16.913 billion (2010), 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, Medical Care and Pharmaceuticals divisions.  Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide.  Bayer HealthCare has a global workforce of 55.700 employees and is represented in more than 100 countries.  Find more information at

About Bayer Yakuhin, Ltd.

Bayer Yakuhin Ltd., headquartered in Osaka, Japan, is a healthcare company which combines business activities of pharmaceuticals, dermatology, Consumer Care (OTC product) and Animal Health (companion and food animal products).  The Pharmaceuticals business is focused on the following areas: Diagnostic Imaging, General Medicine, Oncology, Specialty Medicine and Women's Healthcare. Bayer Yakuhin aims to be one of the leading pharmaceutical companies, which responds to Japanese patients' unmet medical needs, with the spirit of Bayer's corporate slogan, "Science For A Better Life."  Bayer Yakuhin homepage:

Regeneron Forward-Looking Statements

This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future financial performance of Regeneron, and actual events or results may differ materially from these forward-looking statements.  These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's product candidates and research and clinical programs now underway or planned, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product 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 may be 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 license or collaboration agreement, including Regeneron's agreements with the Sanofi and Bayer HealthCare, to be canceled or terminated without any product success, and risks associated with third party intellectual property and pending or future litigation relating thereto.  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, including its Form 10-K for the year ended December 31, 2010 and Form 10-Q for the quarter ended March 31, 2011.  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.

Bayer Forward-Looking Statements

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 .  The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Your Contact at Bayer: Doreen Schroeder, Tel. +49 30 468-11399E-Mail:

Your Investor Relations Contact at Regeneron: Michael Aberman, M.D., Tel. +1 (914) 345-7799E-Mail:

Your Media Contact at Regeneron: Peter Dworkin, Tel. +1 (914) 345-7640E-Mail:

SOURCE Regeneron Pharmaceuticals, Inc.

Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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