Regeneron and Teva Announce Global Collaboration to Develop and Commercialize Fasinumab
OREANDA-NEWS. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today 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, Teva will pay Regeneron $250 million upfront and share equally in the global1 commercial value, as well as ongoing research and development costs of approximately $1 billion.
"This is a significant transaction for Teva, and we look forward to our collaboration with Regeneron, a leader in the research and development of innovative biologics, which aligns with our overall corporate strategy. With our commercial footprint, we will be able to widely educate healthcare providers about this new treatment option when it becomes available," said Rob Koremans, M.D., President and Chief Executive Officer of Global Specialty Medicines for Teva.
"The development of novel pain medicines, such as fasinumab, can be one important step in combating the growing opioid epidemic," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer, Regeneron and President, Regeneron Laboratories. "Fasinumab represents the culmination of more than 25 years of Regeneron scientific work in neurotrophic factors. We look forward to working with Teva, a leading global pharmaceutical company with an expertise in pain therapeutics, to advance this program for patients in need."
Under the terms of the agreement, Regeneron is eligible to receive development and regulatory milestone 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 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.
"Fasinumab has shown proof of concept in early clinical trials, and represents an exciting, novel target for pain relief. Adding the promise of fasinumab to our developing pipeline of pain products also provides a strong, strategic cornerstone to our pain franchise at Teva. It has the potential to provide a treatment option without the concerns of abuse, addiction and misuse of opioids. In the United States alone, it is estimated that 30 million people suffer pain from osteoarthritis and the same number with chronic low back pain," said Michael Hayden, President of Teva Global R&D and Chief Scientific Officer.
Fasinumab is a fully human monoclonal antibody that targets NGF, a protein that plays a central role in the regulation of pain signaling. There is evidence that NGF levels are elevated in patients with chronic pain conditions.
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.
About Osteoarthritis Pain and Chronic Low Back Pain
In the U.S., more than 30 million people live with osteoarthritis pain, and a similar number with chronic low back pain, with both populations expected to grow in the low-single digit percentages annually.2,3 Many patients experience pain at moderate-to-severe levels with intolerance and/or inadequate response to current analgesic therapies such as opioids and NSAIDs.4,5 There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids.3 Opioid prescriptions account for 40 percent of the chronic pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternative pain therapies without the medical and societal challenges.3,6
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world's largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2015 amounted to $19.7 billion.
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 eye diseases, high LDL cholesterol and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer and infectious diseases.