NGF Antibody Fasinumab Currently in Phase 2/3 Osteoarthritis Trial
TARRYTOWN, NY, USA I October 1, 2015 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a collaboration with Mitsubishi Tanabe Pharma Corporation (TSE: 4508) (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.
“Pain is one of the most common causes of disability, suffering and productivity loss across the world, and yet current treatments have limited efficacy, hold the risk of abuse or have other serious side effects,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. “MTPC has proven experience marketing biologics for rheumatology and pain management and thus is an ideal partner in Asia. We look forward to advancing our NGF program in the coming months with the goal of bringing this investigational therapy to patients in serious need.”
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.
About the Fasinumab Program
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 U.S. Food and Drug Administration (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.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for high LDL cholesterol, eye diseases and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation is a research-driven pharmaceutical company based in Osaka, Japan. MTPC is taking on the challenge of drug discovery in the fields of autoimmune disorders, central nervous system diseases, diabetes and kidney diseases, and vaccines. To those ends, MTPC is strengthening its R&D pipeline. MTPC contributes to the healthier lives of people around the world through the creation of pharmaceuticals. www.mt-pharma.co.jp/e.
SOURCE: Regeneron Pharmaceuticals
Post Views: 40
NGF Antibody Fasinumab Currently in Phase 2/3 Osteoarthritis Trial
TARRYTOWN, NY, USA I October 1, 2015 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a collaboration with Mitsubishi Tanabe Pharma Corporation (TSE: 4508) (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.
“Pain is one of the most common causes of disability, suffering and productivity loss across the world, and yet current treatments have limited efficacy, hold the risk of abuse or have other serious side effects,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. “MTPC has proven experience marketing biologics for rheumatology and pain management and thus is an ideal partner in Asia. We look forward to advancing our NGF program in the coming months with the goal of bringing this investigational therapy to patients in serious need.”
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.
About the Fasinumab Program
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 U.S. Food and Drug Administration (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.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for high LDL cholesterol, eye diseases and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation is a research-driven pharmaceutical company based in Osaka, Japan. MTPC is taking on the challenge of drug discovery in the fields of autoimmune disorders, central nervous system diseases, diabetes and kidney diseases, and vaccines. To those ends, MTPC is strengthening its R&D pipeline. MTPC contributes to the healthier lives of people around the world through the creation of pharmaceuticals. www.mt-pharma.co.jp/e.
SOURCE: Regeneron Pharmaceuticals
Post Views: 40
