Pfizer, Eli Lilly to resume late-stage programme for tanezumab after FDA lifts partial clinical hold

Pfizer and Eli Lilly announced Monday that the companies are preparing to resume a Phase III programme for tanezumab after the FDA lifted a partial clinical hold on the drug. "We are pleased with the FDA's decision as chronic pain remains an area of significant unmet medical," commented Steve Romano, head of global medicines development in Pfizer's Global Innovative Pharmaceuticals Business.

The drugmakers noted that the FDA removed the partial clinical hold, which had been in place since December 2012, following "a review of...nonclinical data characterising the sympathetic nervous system response to tanezumab," with the data being submitted last month. The companies added that prior clinical studies involving more than 11 000 patients showed that the drug was associated with clinically meaningful efficacy compared to placebo and commonly used analgesics.

Eli Lilly and Pfizer entered into an agreement in 2013 to jointly develop and market tanezumab for a number of pain-related conditions, with the deal being potentially worth up to $1.8 billion to Pfizer. Under the agreed terms, Pfizer will receive an upfront payment of $200 million from Eli Lilly due to the removal of the clinical hold.

Analysts at Cowen & Co. estimate that tanezumab could amass $100 million in revenue by 2020 if approved, adding that sales could rise if the therapy is cleared for additional indications. Other companies developing similar drugs that target nerve growth factor include Regeneron Pharmaceuticals and Sanofi.

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