Janssen Pharmaceuticals will terminate its license with Amgen for fulranumab—ending a collaboration stretching back 8 years that could have generated up to $435 million for Amgen.
As a result, the Johnson & Johnson entity said, its Janssen Research & Development unit will end Phase III development of the candidate for osteoarthritis pain.
In a statement issued late yesterday after the close of financial markets, Janssen said it was not responding to safety concerns from its Phase III studies, but realigning its clinical development programs with its strategic portfolio.
Janssen has identified its five areas of therapeutic focus as cardiovascular and metabolic diseases, immunology, infectious diseases and vaccines, neuroscience, and oncology.
While the company’s website includes pain management within neuroscience, Janssen’s statement hinted of a narrowing of its focus within that category: “The Neuroscience therapeutic area of Janssen Research & Development, LLC continues to pursue discovery and development programs in Alzheimer's disease and serious mental illness.”
Fulranumab is part of an experimental class of nonopioid biological medicines called anti-nerve growth factor (anti-NGF) compounds.
Last year, Janssen included fulranumab among 10+ new drugs for which it planned to seek regulatory approval. Janssen said the dozen were each projected to reach blockbuster status by 2019, generating annual revenue of more than $1 billion.
The prediction marked a comeback of sorts for fulranumab, since in 2010, the compound was among anti-NGF drugs placed on FDA clinical hold, following concerns over the risk of joint damage. The clinical hold was lifted last year.
In 2008, Janssen predecessor Ortho-McNeil-Janssen Pharmaceuticals licensed worldwide-except-Japan rights for fulranumab to Amgen for $50 million upfront, plus up to $385 million tied to achieving milestones, and royalties.
Takeda holds rights to fulranumab in Japan, where the compound is in Phase I studies, according to the company’s pipeline posted online and last updated February 3.