Teva Pharmaceutical Industries will partner to develop and commercialize Regeneron Pharmaceuticals’ nerve growth factor (NGF) antibody candidate for chronic pain fasinumab for most of the world, through a collaboration that will generate at least $250 million upfront for Regeneron.
Fasinumab is a fully human monoclonal antibody that is in Phase III development for osteoarthritis pain and in Phase II for chronic low back pain. Fasinumab targets NGF, a protein that plays a central role in the regulation of pain signaling.
The companies said evidence has shown that NGF levels are elevated in patients with chronic pain conditions. In May, Regeneron trumpeted positive Phase II/III results showing statistically significant improvement in pain relief 16 weeks after fasinumab treatment in patients with moderate-to-severe osteoarthritis pain of the hip or knee and with a history of inadequate pain relief or intolerance to current analgesic therapies.
“Fasinumab has shown proof of concept in early clinical trials and represents an exciting, novel target for pain relief,” Michael Hayden, president of Teva Global R&D and CSO, said in a statement. “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.”
Teva has agreed to pay Regeneron $250 million upfront, plus unspecified additional payments tied to achieving development and regulatory milestones, and additional payments based on net sales.
Both companies also agreed to share equally in ongoing R&D costs of approximately $1 billion and in the global commercial value of fasinumab.
The collaboration with Teva excludes Japan, Korea, and nine other Asian countries, where Mitsubishi Tanabe Pharma has exclusive development and commercial rights to fasinumab under an up-to-$325 million agreement inked with Regeneron last year.
In the new collaboration with Teva, Regeneron agreed to lead development in most of the world and commercialization in the U.S., although both companies said they will share U.S. commercialization efforts by using sales teams and marketing expertise from both companies and split profit equally in the U.S.
Teva agreed to oversee development and commercialization outside the U.S. in areas covered by the agreement.
Teva also agreed to pay Regeneron an undisclosed purchase price allowing both companies to retain approximately equal shares of fasinumab’s commercial value in the U.S. and everywhere else that is not subject to the Regeneron–Mitsubishi Tanabe collaboration.