Bayer plans to submit for marketing authorization in CRVO end of 2012 in Europe
BERLIN, Germany I September 21, 2012 I Bayer HealthCare’s collaboration partner Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO).
The approval of EYLEA for Macular Edema following CRVO was based on data from the Phase III COPERNICUS and GALILEO studies. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 ETDRS letters of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline on the ETDRS visual acuity charts. The EYLEA 2 milligrams (mg) monthly group was superior to the control group for the primary endpoint. Results from Week 24 through 52 of the COPERNICUS and GALILEO studies have not yet been reviewed by the FDA.
The most common adverse reactions (more than 5%) reported in patients receiving EYLEA were conjunctival hemorrhage, maculopathy, eye pain, increased intraocular pressure, retinal exudates, retinal vascular disorder, and optic disc vascular disorder.
VEGF Trap-Eye was approved under the brand name EYLEA in the United States in November last year and in Australia earlier this year in wet AMD. Recently Bayer received the recommendation for approval of VEGF Trap-Eye for the treatment of patients with wet AMD by the European Committee for Medicinal Products for Human Use (CHMP).
Phase III trials are currently under way with VEGF Trap-Eye 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.
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.
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) 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.
About Central Retinal Vein Occlusion (CRVO)
Over 100,000 people in the United States and more than 66,000 people in major European countries are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina. This causes retinal injury and loss of vision. The retina can also become "ischemic" (starved for oxygen), resulting in the growth of new, inappropriate blood vessels that can cause further vision loss and more serious complications. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and inappropriate new vessel growth. It is believed that anti-VEGF treatment may help decrease vascular permeability and edema.
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: 99
Bayer plans to submit for marketing authorization in CRVO end of 2012 in Europe
BERLIN, Germany I September 21, 2012 I Bayer HealthCare’s collaboration partner Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO).
The approval of EYLEA for Macular Edema following CRVO was based on data from the Phase III COPERNICUS and GALILEO studies. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 ETDRS letters of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline on the ETDRS visual acuity charts. The EYLEA 2 milligrams (mg) monthly group was superior to the control group for the primary endpoint. Results from Week 24 through 52 of the COPERNICUS and GALILEO studies have not yet been reviewed by the FDA.
The most common adverse reactions (more than 5%) reported in patients receiving EYLEA were conjunctival hemorrhage, maculopathy, eye pain, increased intraocular pressure, retinal exudates, retinal vascular disorder, and optic disc vascular disorder.
VEGF Trap-Eye was approved under the brand name EYLEA in the United States in November last year and in Australia earlier this year in wet AMD. Recently Bayer received the recommendation for approval of VEGF Trap-Eye for the treatment of patients with wet AMD by the European Committee for Medicinal Products for Human Use (CHMP).
Phase III trials are currently under way with VEGF Trap-Eye 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.
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.
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) 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.
About Central Retinal Vein Occlusion (CRVO)
Over 100,000 people in the United States and more than 66,000 people in major European countries are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina. This causes retinal injury and loss of vision. The retina can also become "ischemic" (starved for oxygen), resulting in the growth of new, inappropriate blood vessels that can cause further vision loss and more serious complications. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and inappropriate new vessel growth. It is believed that anti-VEGF treatment may help decrease vascular permeability and edema.
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: 99
