Pfizer and Eli Lilly and Company said they will resume Phase 3 clinical studies for tanezumab for chronic pain, after the Food and Drug Administration (FDA) lifted a partial hold on trials.
As a result, Pfizer expects to receive a $200-million upfront payment from Lilly in accordance with their collaboration agreement. If tanezumab is approved, it could have sales of $100 million in 2020, Cowen and Co has forecast, according to Reuters.
FDA lifted the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab, according to Pfizer and Eli Lilly.
“We are pleased with the FDA’s decision, as chronic pain remains an area of significant unmet medical need and we believe tanezumab has potential to offer a new, non-narcotic option,” said Steve Romano, MD, senior vice president and head of Global Medicines Development at Pfizer’s Global Innovative Pharmaceuticals Business.
A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December, 2012, due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed. In the prior clinical studies of more than 11,000 patients, tanezumab “demonstrated clinically meaningful efficacy versus placebo and other select commonly used pain medicines”, according to a statement from Pfizer and Eli Lilly.
Tanezumab is a humanized monoclonal antibody that selectively targets nerve growth factor (NGF), a regulator of pain processing and sensitivity. NGF levels increase as a result of injury or inflammation and in chronic pain states. Tanezumab selectively binds to NGF, thereby inhibiting this protein from activating pain-signaling neurons.
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