Date: 2015-10-01
Type of information: Development agreement
Compound: fasinumab (REGN475)
Company: Regeneron Pharmaceuticals (USA - NY) Mitsubishi Tanabe Pharma (Japan)
Therapeutic area: CNS diseases - Muscular diseases
Type agreement: development commercialisation
Action mechanism: monoclonal antibody. Fasinumab is a fully human monoclonal antibody that is highly selective for Nerve Growth Factor (NGF). In a prior clinical study in osteoarthritis, fasinumab demonstrated reductions in pain compared to placebo and a safety profile that was comparable to placebo. Fasinumab is currently on partial clinical hold by the FDA, limiting duration of trials in osteoarthritis to 16 weeks. The FDA placed fasinumab and other investigational agents against NGF on partial clinical hold in December 2012 due to reports of sympathetic nervous system toxicity in mature animals being treated with other NGF antibodies. A Phase 2b/3 study of fasinumab for pain due to osteoarthritis was initiated in mid-2015 (NCT02683239).
Disease: musculoskeletal pain
Details: * On October 1, 2015, Regeneron Pharmaceuticals announced a collaboration with Mitsubishi Tanabe Pharma Corporation (MTPC) providing MTPC with exclusive development and commercial rights to fasinumab (REGN475), Regeneron's NGF antibody in late-stage development for musculoskeletal pain. Under the terms of the agreement, MTPC will obtain exclusive development and commercial rights to fasinumab in Japan, Korea and nine other Asian countries, excluding China.
Financial terms: Under the agreement, Regeneron will receive up to $55 million in upfront and other near-term payments. The agreement provides for additional payments to Regeneron of up to $170 million in R&D reimbursement payments and development milestones. Upon commercialization, Regeneron will supply the product at a range of purchase prices depending on net sales, such that Regeneron shares in a significant portion of any potential profits. Regeneron is also eligible for additional one-time purchase price adjustment payments of up to $100 million total upon achievement of specified annual net sales.
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