April 1, 2016
By Alex Keown, BioSpace.com Breaking News Staff
TITUSVILLE, N.J. -- Janssen Research & Development, a subsidiary of Johnson & Johnson , terminated its Phase III development program for fulranumab in osteoarthritis pain due to a “strategic portfolio prioritization,” the company announced late Thursday.
Janssen had been developing the drug through a licensing agreement with Amgen, Inc. With its abandonment of the project, Janssen said it is returning all program rights back to Amgen. Fulranumab is part of an experimental class of non-opioid biological medicines called anti-nerve growth factor compounds. Those drug compounds had been placed on a hold by the U.S. Food and Drug Administration (FDA) in 2011 due to heightened risk of joint damage, Seeking Alpha noted. The FDA’s hold has been lifted. Janssen said their reasons for terminating the agreement had nothing to do with safety concerns. The neuroscience therapeutic area of Janssen will continue to pursue discovery and development programs in Alzheimer’s disease and serious mental illness, the company said.
In 2008, Amgen Inc. licensed fulranumab to Ortho-McNeil-Janssen Pharmaceuticals, Inc., now known as Janssen Pharmaceuticals, Inc. Janssen’s development of fulranumab could have generated about $435 million annually for Amgen, Genengnews.com reported.
Janssen’s new 2020 strategy was designed to turn the company into “a transformational medical innovator,” with a focus on the development of innovative therapeutic solutions. Areas of therapeutic focus include cardiovascular and metabolic diseases, immunology, infectious diseases and vaccines, neuroscience, and oncology according to Janssen’s website.
Fulranumab was included in Janssen’s 2015 list of new drugs that had the potential to become blockbuster treatments by 2019, earning more than $1 billion in annual sales. Other drugs the company included in that list are daratumumab for multiple myeloma; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN-509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; JNJ-493 (FGFRi kinase inhibitor) for urothelial cancer; esketamine for treatment-resistant depression; AL-8176 for respiratory syncytial virus (RSV); fulranumab for osteoarthritic pain; JNJ-872 (VX-787) for influenza A; JNJ-922 (Orexin-2 antagonist) for primary insomnia; and AL-335 for hepatitis C.
Takeda Pharmaceuticals currently holds the rights to fulranumab in Japan. The Japanese company licensed the rights to the drug from Amgen in 2008. The drug is currently in a Phase I trial for pain, according to Takeda’s website.
In March, Janssen Research & Development struck a deal with Genentech to initiate two studies to determine the safety and tolerability of daratumumab (Darzalex) and atezolizumab for treatment of in multiple myeloma and in solid tumor.
