Teva Pharmaceutical Industries Ltd. (NYSE:TEVA, TLV:TEVA) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) are teaming up to develop and commercialise globally 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.
Teva will pay Regeneron $250mln upfront and share equally in the global commercial value, as well as ongoing research and development costs of approximately $1bn.
Regeneron will be eligible to receive development and regulatory milestones payments and additional payments based on net sales. Regeneron will lead global development and US commercialisation.
The companies will share US commercialisation efforts by utilising sales teams and marketing expertise from both companies.
They will 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 commercialisation and pay Regeneron a purchase price, which allows both companies to retain approximately equal shares of fasinumab’s global commercial value over time.
In the US, more than 30mln 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. Many patients experience pain at moderate-to-severe levels with intolerance and/or inadequate response to current analgesic therapies such as opioids and NSAIDs.
There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids. Opioid prescriptions account for 40% 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.
Teva ADRs on Wall Street were up 0.04% at $50.72 pre-market Tuesday.