OSAKA, Japan, May 8, 2012 (GLOBE NEWSWIRE) -- Santen Pharmaceutical Co., Ltd. (Head office: Osaka, hereafter referred to as "Santen") announced today that Santen and Bayer Yakuhin, Ltd. (Head office: Osaka, hereafter referred to as "Bayer Yakuhin") concluded on May 7 an agreement of co-promotion of VEGF Trap-Eye (aflibercept intravitreal injection) in the market of Japan. Bayer Yakuhin has submitted an authorization application to the Ministry of Health, Labour and Welfare (MHLW) for marketing this product for the treatment of wet age-related macular degeneration (wet AMD).
With this agreement, medical representatives (MRs) of both companies will start promotional activities of VEGF Trap-Eye after Bayer Yakuhin obtains a marketing authorization from the MHLW. Santen will distribute the product in Japan and Bayer Yakuhin will hold the marketing authorization for the product.
Santen offers a full lineup of pharmaceutical ocular products that deal with problems in the front-of-the-eye region. By adding an outstanding product, i.e., VEGF Trap-Eye, in the product market for the back-of-the-eye area that covers wet AMD, for which Santen offers less treatment options at present, Santen expects to meet the treatment needs of patients and further contribute to the improvement in patients' quality of life (QOL).
With VEGF Trap-Eye, Bayer Yakuhin will enter the product market for the back-of-the-eye area which mainly includes retinal diseases. By partnering with Santen, the leading ophthalmic pharmaceutical company in Japan, Bayer Yakuhin will be able to offer the latest information relating to VEGF Trap-Eye to a broader range of ophthalmologists and contribute to AMD therapy.
About VEGF Trap-Eye
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) with higher affinity than their natural receptors, and thereby can inhibit the binding and activation of these cognate VEGF receptors. VEGF Trap-Eye is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
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. However, in certain diseases, such as wet age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results.
Bayer HealthCare and Regeneron Pharmaceuticals are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion (CRVO), myopicchoroidal neovascularisation (CNV), diabetic macular edema (DME), and other eye diseases and disorders. VEGF Trap-Eye was approved for the indication of wet AMD in the US in November 2011 and in Australia in March 2012.
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. In Japan, age-related macular degeneration (AMD) is the 4th most common cause of acquired blindness and the number of patients is increasing. The research conducted in 2007 targeting residents in Hisayama, Fukuoka, shows that 1.2% of residents over the age of 50 had wet AMD in at least one eye. Extrapolating from this study, the number of patients in Japan estimated to have wet AMD eligible for treatment with anti-VEGF therapy is approximately 700,000.
Reference:
1 Ophthalmic Epidemiology, 17(I), 50-57, 2010: "Prevalence of Visual Impairment in the Adult Japanese Population by Cause and Severity and Future Projections" Masakazu Yamada, Yoshimune Hiratsuka, Chris B. Roberts, M. Lynne Pezzullo, Katie Yates, Shigeru Takano, Kensaku Miyake, and Hugh R. Taylor
About Santen
Founded in 1890, Santen is a global company headquartered in Osaka, Japan. Santen researches, develops and markets ophthalmic products for physicians worldwide. Among prescription ophthalmic pharmaceuticals, Santen holds the top share within the Japanese market and is one of the leading ophthalmic companies worldwide. For more information, visit www.santen.com.
About Bayer Yakuhin, Ltd.
Bayer Yakuhin Ltd., headquartered in Osaka, is a healthcare company which combines business activities of Pharmaceuticals, Radiology & Interventional and Animal Health (companion and food animal products). Pharmaceuticals business is focused on the following areas: Cardiovascular & Neurology, Oncology & Hematology, Women's Health & Dermatology and Ophthalmology. Bayer Yakuhin aims to be one of 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: http://www.bayer.co.jp/byl
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 EUR 17.2 billion (2011), 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 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.
To learn more about age-related macular degeneration (AMD), please visit: www.bayerpharma.de/en/AMD
About Regeneron
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets two products in the United States, one for the treatment of neovascular (wet) age-related macular degeneration and another for the treatment of a rare inflammatory condition. Additionally, Regeneron has three regulatory applications pending before the U.S. Food and Drug Administration (FDA) and 10 drug candidates in clinical development. More information and recent news releases are available on the Regeneron web site at www.regeneron.com
Santen Forward-looking Statements
Information provided in this press release contains so-called "Forward-looking Statements". The realizations of these forecasts are subject to risk and uncertainty from various sources. Therefore, please note that the actual results may differ significantly from the forecasts. Business performance and financial condition are subject to the effects of change in regulations made by the governments of in Japan and other nations concerning medical insurance, drug pricing and other systems, and to fluctuations in market variables such as interest rates and foreign exchange rates.