Three years after Pfizer's once-promising osteoarthritis drug tanezumab blew up in the clinic with the revelation that the treatment--and the entire drug class--had been tied to a serious threat of joint destruction, the pharma giant ($PFE) moved one step closer to getting it back into a late-stage trial. And this time Eli Lilly ($LLY), which rarely does collaboration deals, is signing on to partner on the program.
Pfizer announced in its quarterly statement today that Lilly had agreed to share the cost of development on tanezumab in exchange for a split of the profits. Lilly, which has come under increased scrutiny after a series of high-risk drug programs failed to pan out, will also pay an unspecified upfront--provided the FDA lifts a partial hold on the program.
Back in 2010 tanezumab was widely considered one of the top prospects in the industry's late-stage pipeline. The entire class of anti-nerve growth factor drugs was estimated by some analysts to be worth a potential $11 billion. Then the studies for the drug--as well as therapies at other major developers--were shelved after it became apparent that the pain remedy worked so well a group of patients were blowing out joints that then needed to be replaced.
Faced with an alarming safety risk, the FDA put the field on ice. But last year, after some careful consideration, a panel of outside experts recommended a regulatory thaw, noting that a more careful selection of patients most likely to benefit from these anti-NGF therapies could be used to safely study the treatment for certain populations.
"There's significant risk but there are probably patient populations where there will be significant benefit," Lenore Buckley, a professor at Virginia Commonwealth University School of Medicine and chair of the FDA panel, told Bloomberg at the time.
"The tanezumab program currently is subject to a partial clinical hold by the FDA pending submission of nonclinical data to the FDA," Pfizer said in its release today. "Pfizer anticipates submitting that data in the first half of 2014. Under the agreement with Lilly, Pfizer is eligible to receive certain payments from Lilly upon the achievement of specified clinical, regulatory and commercial milestones, including an upfront payment that is contingent upon the parties continuing in the collaboration after receipt of the FDA's response to the submission of the nonclinical data. Both Pfizer and Lilly have the right to terminate the agreement under certain conditions."
Tanezumab's return to Pfizer's late-stage planning is important, particularly given the weak debuts of Eliquis and Xeljanz. CEO Ian Read today also highlighted the advance of the PCSK9 program bococizumab (RN316) and a Phase III launch of the SGLT2 diabetes drug ertugliflozin, which is partnered with Merck ($MRK). Pfizer's top prospects in Phase III remain palbociclib, dacomitinib and a Staphylococcus aureus vaccine the pharma giant has high hopes for.
- here's the Q3 release