BLA Acceptance for Tanezumab, page-6

Hi Jerund,

It's good that you're asking the hard questions. I agree that it would be wrong to completely dismiss tanezumab as a competitor, the low dose 2.5mg technically did not fail the phase 3 trial as it met 2 out of the 3 co-primary endpoints against placebo. Crucially it met it's Womac pain endpoint, which will be PAR's only primary endpoint for its upcoming trial. Interestingly though, it failed to demonstrate statistical significance against naproxen (an NSAID similar to Nurofen). However, it's an inferior competitor for all of the reasons Mozz pointed out. I might also add that there is evidence to suggest from the Phase 2b data that iPPS is actually disease-modifying. Tanezumab certainly cannot claim that. You could say that iPPS is regenerative for the joint whereas tanezumab is in fact degenerative (as evidenced by some of the more severe OA patients who suffered the SAEs). It's the very reason some on the higher dose had to leave the trial. It masks the pain but further destroys your knee. This will be a key differentiating factor when it hits the market.

My take on it is that Pfizer want to see if they can salvage at least some return out of their multi-billion dollar investment. 18,000 patients over 39 clinical trials!! You can totally under their situation. They had virtually zero chance of getting the 5mg or 10mg approved. The 2.5mg was their only shot so they said f@#$ it, why not? Also, just because they lodged an application does not mean it will be successful. There is probably enough of a case for it to be assessed in detail. The FDA will no doubt engage the key opinion leaders in the field (like our very own Prof David Felson) to determine whether the pros justify the cons. I would say it's a 50/50. At best they will temporarily fill a void in the market, such is the desperation for a new treatment. If tanezumab manages to get approved and sets a high benchmark for pricing, it may even be a blessing in disguise for Zilosul when it eventually enters the market.