Janssen ends phase 3 development of osteoarthritis pain drug
Janssen has ended the troubled phase 3 development programme for its fulranumab osteoarthritis pain drug, deciding that it was no longer a priority.
The Johnson & Johnson (J&J) unit said yesterday that the decision was based on “strategic portfolio prioritisation”, and was not based on any emerging safety concerns from phase 3 studies.
Janssen added it is terminating a licensing agreement with Amgen and is returning all programme rights to Amgen. Amgen made no immediate comment on the announcement on its website.
Janssen had planned to file anti-nerve growth factor (anti-NGF) fulranumab by the end of 2015. But research had been seriously delayed after the US Food and Drug Administration (FDA) demanded a clinical hold on fulranumab and similar drugs in 2010 because of unexpected joint damage in animal trials.
The FDA has since lifted the hold and Pfizer and Lilly said a year ago that they were planning to resume phase 3 development of rival drug tanezumab.
But even though J&J CEO Alex Gorsky cited fulranumab as a potential sales driver earlier this year, the company has clearly got cold feet over the drug it licensed in from Amgen in 2008.
Janssen said it continues to pursue discovery and development programmes in Alzheimer’s disease and serious mental illness.
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