Four months after Regeneron’s NGF pain med largely came through in a Phase II/III clinical trial, Teva is paying $250 million in cash to buy into the late-stage product while agreeing to cover half the billion-dollar development cost and splitting future profits. A Regeneron spokesperson tells Endpoints News that the deal comes with $2.36 billion in development and sales milestones.
In the deal, Regeneron $REGN will take the lead on US development of fasinumab, with a chance to earn milestones along the way and later sharing commercialization duties. Teva $TEVA will take the reins on R&D and commercialization outside of the US. The drug is now in a Phase III study for osteoarthritis pain while a mid-stage study is underway for lower back pain.
NGF drugs were all the rage until five years ago, when some of the patients in clinical studies began to blow out their joints with meds designed to silence nerve growth factors. The safety issues sidelined the drugs, but developers slowly worked out a plan to protect patients, and Pfizer got back into the clinic, with Eli Lilly signing on to partner in a $1.8 billion deal. J&J came back in right alongside, with falranumab, inlicensed from Amgen.
Even though J&J had a huge Phase III effort underway, with four late-stage studies, the pharma giant decided to abandon the work earlier this year, saying only that it was reprioritizing its pipeline.
For Regeneron, the new partnership marks the latest in a string of high-profile collaborations. Its tie-up with Sanofi remains the pharma giant’s biggest late-stage asset. And Regeneron seems to thrive on drug deals like this, enjoying rapidly growing revenue while continuing to make progress with its pipeline.
In this case, the drugmakers see a major opportunity in coming up with a new way to control pain aside from the opioids which have addicted patients around the world. Regeneron’s latest study, though, also reflected a high placebo effect, underscoring some old fears that have plagued the field for years.
Regeneron, which successfully put a PCSK9 drug through the clinic, is no stranger to major Phase III programs like this. The booming biotech expects to recruit 10,000 patients for the late-stage study, says Regeneron’s Michael Aberman, the VP of strategy, so the billion-dollar price tag is not unique.
In this case Regeneron is counting on some preclinical insights on this drug’s affinity to different receptors “where we think ours is particularly selective,” Aberman adds. But they won’t know until the end of Phase III just how this drug may distinguish itself from the competition.
But the potential market here is huge.
“It’s hard to pick up a newspaper without reading about opioid addiction,” Aberman tells me. And that illustrates the kind of high level interest in new non-opioid drugs like this that reaches right up into the oval office.
Said Regeneron CSO George D. Yancopoulos:
“The development of novel pain medicines, such as fasinumab, can be one important step in combating the growing opioid epidemic. Fasinumab represents the culmination of more than 25 years of Regeneron scientific work in neurotrophic factors.”
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