Date: 2016-03-24
Type of information: Development agreement
Compound: nesvacumab and aflibercept
Company: Bayer Healthcare (Germany) Regeneron Pharmaceuticals (USA - CA)
Therapeutic area: Ophtalmological diseases
Type agreement: development collaboration
Action mechanism: monoclonal antibody/fusion protein /VEGF receptor. Aflibercept 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. It 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. Discovered by scientists at Regeneron, angiopoietins are a family of vascular growth factors. Preclinical data demonstrates that angiopoietins act together with the VEGF family to promote the formation and maturation of blood and lymphatic vessels in the eye. Ang2 and VEGF together therefore have the potential to influence the pathological development of new blood vessels and the permeability of blood vessel walls in certain diseases of the eye. Nesvacumab is a fully human monoclonal antibody directed against angiopoietin 2 with potential antiangiogenic and antineoplastic activities. It interferes with the interaction between Ang2 and its receptor TEK tyrosine kinas e (Tie2), which may inhibit tumor cell angiogenesis and tumor cell proliferation.
Disease: ophtalmological diseases including wet age-related macular degeneration, diabetic macular edema
Details: * On March 24, 2016, Regeneron Pharmaceuticals and Bayer announced that they will jointly develop a combination therapy of the angiopoietin2 (Ang2) antibody nesvacumab and the vascular endothelial growth factor (VEGF) trap aflibercept, for the treatment of serious eye diseases. Two separate Phase 2 clinical studies are evaluating the combination therapy as a co-formulated single intravitreal injection in patients with wet age-related macular degeneration or diabetic macular edema (ONYX study - NCT02713204 and RUBY - study NCT02712008). Regeneron and Bayer currently collaborate on the global development and commercialization of Eylea® (aflibercept) Injection and on the global development of REGN2176-3, the Platelet Derived Growth Factor Receptor Beta (PDGFR-beta) antibody rinucumab co-formulated in a single intravitreal injection with aflibercept, which is currently in Phase 2 clinical trials for patients with wet age-related macular degeneration.
Financial terms: Under the terms of the agreement, Regeneron will receive a $50 million upfront payment and will share global development costs for the program with Bayer. Bayer will have exclusive commercialization rights to the combination product outside the United States and will share potential profits equally with Regeneron. Within the U.S., Regeneron retains exclusive commercialization rights and will retain 100 percent of profits from U.S. sales. Regeneron is also eligible to receive up to $80 million in potential payments related to development and regulatory milestones.
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