Late yesterday, Pfizer suspended all clinical trials of tanezumab, an experimental biotech drug for osteoarthritis, after some patients actually fared worse and had to have joint replacement surgery (seestatement). This also means an end to trials for patients without osteoporosis in which the drug was being tested for cancer pain, interstitial cystitis and painful diabetic peripheral neuropathy. Interestingly, this comes a week after Pfizer presented positive data at a medical meeting showing the drug significantly reduced knee pain better than a placebo ( see this).
This is only the latest in a string of big setbacks for the big drugmaker, starting with torcetrapib, a cholesterol pill that Pfizer hoped would not only revolutionize treatment, but its financial statement. Earlier this year, an experimental Alzheimer's drug that Pfizer had licensed failed two-late stage clinical trials; known as dimebon, Wall Street quickly called it dimebomb. And two phase III studies of its Sutent breast cancer drug failed to meet their principal goals. Feel free to write in with others. Of course, with fewer drugs, Pfizer has fewer concerns about properly reporting adverse events (see this).
Wall Street is, predictably, scornful of Pfizer's R&D track record. Here is a sampling of analyst remarks this morning: "Pfizer has probably lost its advantage in lead time over the competition, and at worst, tanezumab is a clunker and another major phase III failure to add to a lengthy, expensive list," write Deutsche Bank analyst Barbara Ryan, in an investor note.
In his own note, Jon LeCroy of Hapoalim Securites, opines: "We view a clinical hold as a major negative and are removing tanezumab from our Pfizer model. We also view this as a major blow against Pfizer, as we considered tanezumab to be Pfizer’s most promising pipeline drug." He concludes by noting that Pfizer has the "worst pipeline" among big drugmakers.
Leerink Swann analyst Seamus Fernandez offers an equally dismal outlook: "This represents yet another phase III pipeline failure removing another upside opportunity from Pfizer's late-stage pipeline. Despite the fact that this failure has only a small impact on our P&L forecasts, it is further evidence of Pfizer's R&D productivity challenges."
Finally, consider what Sanford Bernstein analyst Tim Anderson had to say: "The commercial case for tanezumab in osteroarthritis pain has long baffled us....
"...Tanezumab would have to be given as an injection, and would compete in a category (pain) filled with many existing medicines the vast majority of which are given orally. Naturally, the product seemed destined to be a last-line therapy for OA pain. What this does is cast a pall over Pfizer's broader R&D abilities as the company has been highlighting tanezumab as one of its promising late-stage products worthy of phase III development."