BLA Acceptance for Tanezumab, page-4

Jerund,

Thanks for your post, important to keep tabs on what the competition is up to and how it could affect us. In this case I'm not at all worried. To me it's partly a timing issue, Tanezumab has shown to have a better efficacy compared to other drugs and in a lot of cases the pain relief is good (around 53.5% of patients achieved a 50% reduction in pain). This is less than iPPS with iPPS achieving around 60% of patients having a 50% pain reduction. As we have discussed iPPS has very little to no side effects and certainly no AE's.

The BLA is up for consideration by Dec 2020. If the BLA is passed and we find that Tanezumab hits the market then of course I acknowledge they will have a good head start on us. It will take them a few months to start selling, by then we might start to get some decent results out initially during Phase three. But like most inferior products, once we eventually hit the market, Tanezumab will be nothing before us.


There are a few other disadvantages of Tanezumab that I know about

1) Has to be stored in fridge

2) Has to be taken every 8 weeks, for life

3) The only allowed dosage of 10mg has less efficacy...the 20mg was the one that had better results but the FDA last failed it due to higher level of AE's. As far as I know they will never allow the 20 mg version.

Once the world gets to know and hear about us, in my view anything inferior won't be an issue. The prescribing Doctors will also be eventually aware of what we have, how it performs and when patients cotton on, they will be demanding us. Health is the first priority for anyone.

Oh, one more point

4) Tanezumab Is more expensive than us, it's a biologic.

I think the FDA are under a lot of pressure to counter-act Opioids, this is the closest possibility for assisting with OA today (apart from us). I can't see this being an issue at scale. There is just too much evidence that Tanezumab has problems and it may not be every patient, it may not even be the majority, but if I were a patient, I would want the best, the safest and the one that gave me max pain relief and if it came in at a less price then I and a few other hundred million others would vote with their feet...the payers will think the same.... more effective, less pain...less expense, and chances of something going awry for the patient? Less as well.

An inferior product that is released early will still be outperformed in the long run. Think of the iPhone...it is in NO WAY the first smartphone...or was it the first in most of the technology areas as they came out...glass screen, better camera, faster chip set etc. But as it came out, how wildly popular was it despite it not being first in class in every aspect...the difference is with us..we will be.

My views