Decision of European Commission on approval expected in fourth quarter 2012
BERLIN, Germany I September 21, 2012 I Bayer HealthCare’s VEGF Trap-Eye (aflibercept ophthalmic injection) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD). The decision of the European Commission is expected in the fourth quarter 2012.
“The positive recommendation by the CHMP to approve VEGF Trap-Eye is great news for patients in Europe suffering from wet AMD,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “We soon expect to be able to offer wet AMD patients and their physicians this new treatment option.”
Beyond the wet AMD indication, Phase III trials are currently under way with VEGF Trap-Eye (aflibercept ophthalmic injection) in the treatment of diabetic macular edema (DME) and myopic choroidal neovascularization (mCNV). Bayer plans to submit for marketing authorization in central retinal vein occlusion (CRVO) in Europe end of 2012.
VEGF Trap-Eye was approved under the brand name EYLEA in the United States in November last year and in Australia earlier this year and has been submitted for marketing authorization in additional countries including Japan. Regeneron has filed a supplemental Biologics License Application (sBLA) for EYLEA in Macular Edema following Central Retinal Vein Occlusion (CRVO) in the United States and has been granted a Prescription Drug User Fee Act (PDUFA) date of September 23, 2012.
Bayer HealthCare and Regeneron are collaborating on the global development of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of VEGF Trap-Eye, except for Japan where Regeneron will receive a royalty on net sales.
About VEGF Trap-Eye (aflibercept ophthalmic injection)
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. VEGF Trap-Eye is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
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.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia. Additional information and recent news releases are available on the Regeneron web site at 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 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. More information at www.healthcare.bayer.com.
SOURCE: Bayer HealthCare
Post Views: 84
Decision of European Commission on approval expected in fourth quarter 2012
BERLIN, Germany I September 21, 2012 I Bayer HealthCare’s VEGF Trap-Eye (aflibercept ophthalmic injection) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD). The decision of the European Commission is expected in the fourth quarter 2012.
“The positive recommendation by the CHMP to approve VEGF Trap-Eye is great news for patients in Europe suffering from wet AMD,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “We soon expect to be able to offer wet AMD patients and their physicians this new treatment option.”
Beyond the wet AMD indication, Phase III trials are currently under way with VEGF Trap-Eye (aflibercept ophthalmic injection) in the treatment of diabetic macular edema (DME) and myopic choroidal neovascularization (mCNV). Bayer plans to submit for marketing authorization in central retinal vein occlusion (CRVO) in Europe end of 2012.
VEGF Trap-Eye was approved under the brand name EYLEA in the United States in November last year and in Australia earlier this year and has been submitted for marketing authorization in additional countries including Japan. Regeneron has filed a supplemental Biologics License Application (sBLA) for EYLEA in Macular Edema following Central Retinal Vein Occlusion (CRVO) in the United States and has been granted a Prescription Drug User Fee Act (PDUFA) date of September 23, 2012.
Bayer HealthCare and Regeneron are collaborating on the global development of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of VEGF Trap-Eye, except for Japan where Regeneron will receive a royalty on net sales.
About VEGF Trap-Eye (aflibercept ophthalmic injection)
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. VEGF Trap-Eye is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
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.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia. Additional information and recent news releases are available on the Regeneron web site at 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 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. More information at www.healthcare.bayer.com.
SOURCE: Bayer HealthCare
Post Views: 84
