Teva Pharmaceutical Industries and Regeneron Pharmaceuticals. today announced an agreement to develop and commercialize pain drug fasinumab, Regeneron’s investigational NGF antibody in Phase 3 clinical development for osteoarthritis pain and in Phase 2 development for chronic low back pain.
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 the terms of the agreement, Teva will pay Regeneron $250 million upfront and share equally in the global commercial value (excluding Japan, Korea and other Asian countries covered by a previous collaboration), as well as ongoing R&D costs of about $1 billion.
Regeneron is eligible to receive development and regulatory milestones payments and additional payments based on net sales. Regeneron will lead global development and US commercialization. The companies will share US commercialization efforts by utilizing sales teams and marketing expertise from both companies, and split profit equally in the US In countries outside the US, 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 Teva Global R&D president and CSO Michael Hayden.