|J&J CEO Alex Gorsky|
Back in early 2015, J&J ($JNJ) CEO Alex Gorsky tapped the Phase III anti-NGF pain drug fulranumab as one of the pharma giant's top 10 new drug prospects, a key asset in the company's game plan for achieving growing drug sales. On Thursday evening, J&J swept the one-time heavyweight contender out the back door with barely a comment.
Currently in four big studies, according to clinicaltrials.gov, J&J has decided to hand it all back to Amgen ($AMGN), where it found the drug in 2008 and licensed rights to it in a $435 million pact. Years of trial expenses and blockbuster hopes that once pegged the anti-NGF class as an $11 billion market in the making--before a safety disaster blighted the field in 2012 and forced a slow comeback effort--have been written off.
"This decision was based on strategic portfolio prioritization and was not based on any emerging safety concerns from the Phase 3 clinical studies with fulranumab," the company stated.
And that was it.
Five years ago, J&J's osteoarthritis pain drug was in one of the hottest R&D races in the industry. Like Pfizer's ($PFE) tanezumab and Regeneron's ($REGN) fasinumab, the drug targets nerve growth factor to silence pain. But the drug worked too well, leading patients in the studies to blow out their joints and triggering a clinical hold for the class at the FDA.
But the big biopharma groups never lost their appetite for anti-NGFs. Eli Lilly signed up for a $1.8 billion partnership with Pfizer in 2013, with a $200 million upfront they paid in early 2015, when the agency lifted their hold and gave the field a green light to renew their work. Regeneron, meanwhile, inked a $325 million Asia pact last fall with Mitsubishi Tanabe on their anti-NGF, fasinumab (REGN475).
I asked J&J why they would simply hand over the drug at this stage, but a spokesperson merely repeated back the same line the company used in the release. Amgen, meanwhile, tells me they are considering their options.
- here's the release