Teva and Regeneron Pharmaceuticals announced an agreement Tuesday potentially worth as much as $2.6 billion to develop and market the latter's experimental nerve growth factor (NGF) antibody fasinumab for the treatment of pain. "Fasinumab has shown proof of concept in early clinical trials, and represents an exciting novel target for pain relief," remarked Michael Hayden, president of global R&D at Teva, adding that "it has the potential to provide a treatment option without the concerns of abuse, addiction and misuse of opioids."
Under the deal, Teva will make an upfront payment of $250 million to Regeneron, which is also eligible to receive as much as $460 million in development and regulatory milestones, as well as contingent payments of up to $1.9 billion based on specified annual net sales. The companies noted that they will share equally in the global commercial value of fasinumab, as well as ongoing R&D costs of approximately $1 billion.
In addition, the agreement calls for Regeneron to head global development and US commercialisation for fasinumab. Both companies will devote staff for US marketing efforts and equally share profits generated by fasinumab in the country. For markets outside the US that are not covered by Regeneron's previously announced collaboration with Mitsubishi Tanabe Pharma, Teva will be responsible for development and commercialisation activities, and will also pay Regeneron a purchase price, which the companies said will allow them "to retain approximately equal shares of fasinumab's global commercial value over time."
Fasinumab is currently in late-stage development for the treatment of osteoarthritis pain and is also undergoing Phase II testing for use against chronic low back pain. In May, Regeneron unveiled top-line results from a Phase II/III study demonstrating that the therapy significantly improved pain versus placebo in certain adults with moderate-to-severe osteoarthritis of the hip or knee.
Meanwhile, Eli Lilly recently suggested that its investigational NGF antibody tanezumab could be one of as many as 20 new products it hopes to launch within the next decade. Late-stage clinical development of tanezumab, which is partnered with Pfizer, was resumed last year after the FDA lifted a partial clinical hold on the drug.
For additional analysis on the deal between Teva and Regeneron, see ViewPoints: With caution necessary, Teva steps into NGF antibody game.
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