(The following press release from Bayer was received by e-mail. It was not confirmed by the sender.) Dear Newsletter Subscriber, The following news item has been released: Not intended for U.S. and UK Media Bayer Submits VEGF Trap-Eye (aflibercept solution for injection) for Treatment of Diabetic Macular Edema in Japan Berlin, March 3, 2014 - Bayer HealthCare today announced that Bayer Yakuhin, Ltd., Osaka, Japan, has submitted an application for marketing authorization for VEGF Trap-Eye (aflibercept solution for injection) for the treatment of patients with diabetic macular edema (DME) to the Ministry of Health, Labour and Welfare (MHLW) in Japan. "Clinically significant DME is a leading cause of vision loss in the working age population suffering from diabetes. The number of patients suffering from diabetes on a worldwide basis continues to increase, and with it the need for new treatment options. Whatever a person`s age, vision impairment impacts everyday tasks and has a detrimental effect on quality of life", said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "With this filing, we hope to make a significant contribution towards alleviating the impact of this disease for the future in Japan." The submission of VEGF Trap-Eye (aflibercept solution for injection) for DME in Japan is based on data from VISTA-DME and VIVID-DME studies. In the Phase 3 VIVID-DME and VISTA-DME trials, VEGF Trap-Eye 2 milligrams (mg) dosed monthly and VEGF Trap-Eye 2 mg dosed every two months (after 5 initial monthly injections), achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks. One-year data from the VIVID-DME and VISTA-DME trials were already presented at medical congresses in the U.S. and Europe. Both trials are planned to continue up to 148 weeks. VEGF Trap-Eye has been approved under the brand name EYLEA® in Europe, Japan, Australia, the United States, and in many other countries for the treatment of patients with neovascular age-related macular degeneration (wet AMD). EYLEA has also been approved in Europe for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) as well as in Japan, in selected countries in Asia, Latin America and the U.S. for the treatment of macular edema following CRVO. Regulatory submissions have also been made in the EU, the U.S., and other countries, for EYLEA for the treatment of Diabetic Macular Edema, and in Japan additionally for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales. About the Phase 3 DME Program The Phase 3 DME program consists of three double-masked trials: VIVID-DME, VISTA-DME, and VIVID-EAST, and one open label single arm safety trial in Japanese patients (VIVID-Japan). All three double masked studies have three treatment arms, where patients are randomized to receive either VEGF Trap-Eye 2 mg monthly, VEGF Trap-Eye 2 mg every two months (after 5 initial monthly injections), or the comparator treatment of laser photocoagulation. Based on protocol specified criteria, patients were eligible to receive rescue treatment from week 24 onwards. Rescue treatment was adjunct laser treatment for both VEGF Trap-Eye arms and VEGF Trap-Eye 2mg for the laser group. The primary endpoint of these three studies is the mean change in best-corrected visual acuity from baseline, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity. The VIVID-DME, VISTA-DME and VIVID-EAST studies are ongoing. About Diabetic Macular Edema (DME) DME is a common complication of Diabetic Retinopathy (DR), a disease affecting the blood vessels of the retina. Clinically significant DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness. DME is the most frequent cause of blindness in young and mid-aged adults. The treatable population for DME globally is estimated at about 6.2 million people. According to the American Diabetes Association, over 18 million Americans currently suffer from diabetes, and many more are at risk for developing diabetes. The incidence of diabetes is steadily climbing and it is projected that up to seven percent of all patients with diabetes will develop DME during their lifetime. About VEGF and VEGF Trap-Eye (aflibercept solution for injection) Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. VEGF Trap-Eye is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. VEGF Trap-Eye acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors. About Regeneron Pharmaceuticals Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. For additional information about the company, please visit http://www.regeneron.com. About Bayer HealthCare The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), 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, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com. Our online press service is just a click away: http://press.healthcare.bayer.com Follow us on Facebook: http://www.facebook.com/healthcare.bayer Follow us on Twitter: https://twitter.com/BayerHealthCare Find more information at http://www.bayerpharma.com. 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 http://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 Statements This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation EYLEA®(aflibercept) Injection; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s product candidates in clinical trials; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products, such as the application of EYLEA® (aflibercept) Injection in the treatment of Macular Edema following Branch Retinal Vein Occlusion and in the treatment of Diabetic Macular Edema; ongoing regulatory obligations and oversight impacting Regeneron’s research and clinical programs and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare, to be cancelled or terminated without any further 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, 2013. The reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. This press release is available here: http://www.baynews.bayer.de/baynews/baynews.nsf/id/2014-0070-e Yours BayNews Editorial Team Bayer AG Communications Building W11 51368 Leverkusen, Germany --------------------------------------------------- Further news releases you can find here: http://www.press.bayer.com N.B. This is an automatically generated e-mail which you cannot reply to. 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BAYER SUBMITS REGULATORY SUBMISSION OF EYLEA IN JAPAN (ENGLISH)
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