Biotech Values

[DewDiligence]

Re: ABGX (Panitumumab)

>Dew, Concerning P-Mab, just wondering what you now think of its chances of - 1) being approved and, 2) ultimately taking market share away from Erbitux?<

I think approval based on the PFS endpoint in the “408” trial is very likely, perhaps 90%. Why so high? Because Roger Perlmutter has a reputation as a no-BS guy and Perlmutter says the requisite sensitivity analyses to account for potential bias in the PFS data were statsig by a wide margin (#msg-8769391). Since PFS was the primary endpoint, I can’t see what grounds the FDA would use for rejecting these data. (If the “408” trial had an SPA, my estimated probability of approval would be at least 95%.)

>I see that P-Mab has a dosing advantage over Erbitux (dosed every other week vrs weekly dosing), plus there's no need for premedication, and it has a very low incidence of infusion reactions.<

Let’s take these one at a time. The dosing advantage is somewhat consequential—no argument there. However, the pre-medication/infusion-reaction issue is bunk, IMHO. Erbitux has a low rate of infusion reactions, in the 1-3% range, and these are rarely problematic. Moreover, even Panitumumab patients must be watched for an infusion reaction, with epinephrine at the ready, because a severe infusion reaction not quickly treated with epi could result in death. Hence, Pani will have to be administered in the same kind of physical setting as Erbitux.

The “bundling” issue could conceivably allow AMGN to sell Pani more cheaply to high-volume cancer clinics, but the new Medicare reimbursement formula based on actual average price (rather than the old fictitious benchmark price) would work against AMGN if they did that. Hence, I think this supposed advantage of Pani can be ignored. AMGN may opt to price Pani lower than Erbitux but, if they do this, it won’t be due to bundling.

>I remember you mentioning that reimbursement might be a challenge for P-Mab, and that Erbitux has the advantage of having more varied clinical data supporting its use.<

My point was—and still is—that Medicare and private payers will probably not view Pani as a generic Erbitux. In other words, the payers will likely insist on clinical data in each disease setting in order to reimburse for Pani in that setting. AMGN’s “408” trial is a monotherapy-only study, and monotherapy constitutes less than 10% of Erbitux sales. Regards, Dew

p.s. You didn’t mention IMCL’s “combo use” patent, but that’s just as well because I don’t think this patent is worth much.