Johnson & Johnson has returned the rights to fulranumab to Amgen, raising another question mark over the role of nerve growth factor (NGF) blockers as pain therapies.
J&J confirmed last week that it is discontinuing all phase III trials of fulranumab – a drug it licensed from Amgen in a deal valued at around $425m in 2008 – and was returning rights to its originator.
The company said the decision was based on “strategic portfolio prioritisation and was not based on any emerging safety concerns from the phase III clinical studies with fulranumab” in osteoarthritic pain. The company did not indicate however whether the drug’s efficacy was behind its decision.
Last year, J&J chief executive Alex Gorsky listed fulranumab among 10 planned marketing applications for its pharma division between 2013 and 2017, indicating the drug had significant sales potential.
At the time, his comments were seen as a sign that fulranumab was back on course after a tricky development pathway that saw the drug placed under an FDA clinical hold in 2011 – along with other anti-BGF drugs – after being linked to an increased risk of joint damage and possible peripheral nervous system side effects.
Last year, the FDA relaxed two separate clinical holds on another NGF blocker – Eli Lilly and Pfizer’s tanezumab – clearing the way for the two companies to restart pivotal trials of their candidate.
Another NGF blocker – Regeneron/Sanofi’s fasinumab – is listed in the companies’ pipelines as being in phase III but AstraZeneca abandoned its Medi-578 candidate in 2010 and AbbVie has also dropped another NGF blocker called ABT-110.
Analysts have previously predicted that NGF inhibitors could become a multibillion-dollar market opportunity if they show safety and efficacy in phase III trials and are approved by regulators, potentially becoming the first completely new pain therapeutic class in more than a decade.