Date: 2016-09-20
Type of information: Development agreement
Compound: fasinumab (REGN475)
Company: Teva Pharmaceutical Industries (Israel) Regeneron Pharmaceuticals (USA - NY)
Therapeutic area: Rheumatic diseases - Inflammatory diseases – Bone diseases
Type agreement: development commercialisation
Action mechanism: monoclonal antibody. Fasinumab is a fully human monoclonal antibody against Nerve Growth Factor (NGF) that was designed to reduce pain sensitization in neurons. Preclinical experiments indicate that fasinumab specifically binds to NGF and blocks NGF activity, and that fasinumab does not bind to or block cell signaling for closely related neurotrophins (NT) such as NT-3, NT-4 or BDNF (brain-derived neurotrophic factor). 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 anti-NGFs. Fasinumab is no longer on clinical hold by the FDA. A Phase 2b/3 study in pain due to osteoarthritis initiated in mid-2015, and an additional Phase 3 trial of greater than 16 weeks is expected to begin in the first half of 2016.
Disease: osteoarthritis pain, chronic pain
Details: * On September 20, 2016, Teva Pharmaceutical Industries and Regeneron Pharmaceuticals announced a global1 agreement to develop and commercialize fasinumab, Regeneron's investigational NGF antibody in Phase 3 clinical development for osteoarthritis pain and in Phase 2 development for chronic low back pain.
Under the terms of the agreement, Regeneron is eligible to receive development and regulatory milestones payments and additional payments based on net sales. Regeneron will lead global development and U.S. commercialization. The companies will share U.S. commercialization efforts by utilizing sales teams and marketing expertise from both companies, and split profit equally in the U.S. In countries outside the U.S. with the exception of those covered by a previously announced collaboration agreement between Regeneron and Mitsubishi , Teva will be responsible for development and commercialization and pay Regeneron a purchase price, which allows both companies to retain approximately equal shares of fasinumab's global1 commercial value over time.
Under a previously announced collaboration agreement with Regeneron, Mitsubishi Tanabe Pharma has exclusive development and commercial rights to fasinumab in Japan , Korea and nine other Asian countries.
Financial terms: Under the terms of the agreement, Teva will pay Regeneron $250 million upfront and share equally in the global commercial value, as well as ongoing research and development costs of approximately $1 billion . Regeneron is eligible to receive development and regulatory milestones payments and additional payments based on net sales.
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