Johnson & Johnson's (NYSE:JNJ) decision to drop fulranumab leaves Pfizer’s (NYSE:PFE) tanezumab as the lone anti-nerve growth factor antibody in late-stage development. Bringing non-opioid painkillers to market has proven all but impossible over the years, and the canning of fulranumab ups the stakes: success for this project appears even less likely, but if it does succeed the rewards will be that much greater.
Pfizer is maximizing tanezumab’s chances by studying it in several conditions, from osteoarthritis to cancer pain. The first of its phase III trials to read out will be Tango, in chronic low back pain, nearly a year hence, and the amount of money Pfizer is throwing at development means that it needs a hit to justify the expense.
While J&J has made it clear that it is not discontinuing fulranumab in osteoarthritis pain because of any concerns about safety, instead citing “strategic portfolio prioritization”, worries that there could be read-through of some sort to tanezumab will surely linger.
The partial clinical hold on tanezumab, imposed in 2010 after cases of suspected osteonecrosis, was lifted last year, but investors are still wary of NGFs, as their limited sales forecasts show (Tanezumab’s return shows pharma has held its nerve, March 24, 2015).
Certainly the comprehensive trial programme for tanezumab – it is in four global phase III trials in nearly 6,000 patients, and two more in a further thousand or so are planned – will investigate its safety thoroughly. But it will take time: the trials already under way will read out between February next year and May 2018.
Tango, which will pit tanezumab against tramadol and placebo in 1,800 patients who have had low back pain for at least three months, has as primary endpoint of changes to patients’ daily average score on the Low Back Pain Intensity scale compared with placebo.
But the tramadol comparison might be more interesting from a commercial point of view. If tanezumab can provide similar levels of analgesia to tramadol it ought to do well in a market where opioid drugs are increasingly viewed as dangerous and are strictly controlled.
Two trials in osteoarthritis of the hip or knee are ongoing, the first of which, testing tanezumab against placebo, should yield data in July 2017. A larger worldwide study in 3,000 patients is set to report in 2018, and uses NSAIDS – naproxen, celecoxib or diclofenac – as controls.
Fulranumab was also being tested in osteoarthritis pain – the only indication for which it had entered late trials. Four phase III studies in a total of 2,250 patients are listed on Clinicaltrials.gov as currently recruiting patients, though since they are also described as being conducted by J&J it seems likely that these are now being wound down.
Also of interest is the 255-patient study evaluating tanezumab in patients with pain caused by bone metastases. These patients are already taking background opioid therapy.
Hedging Pfizer's bets on the indications will not profit if the project is a dud, of course. But there is the possibility that tanezumab could work in some types of pain but not others, and if this is the case its success will mean greater rewards now that fulranumab is out of the picture.