Our infallible biotech journalist/analyst Adam Feuerstein relays the investor polls taken by Schoenenbaum of ISI on the SVR4 expectation for 7977/RBV and 7977/BMS790052[forgive him for the minor errors of dosing schedules for Incivek and Rbv]. They forecast the SVR4 for the former trial: 60%(Electron) and 62%(genotype 1 of Quantum), and a 77% for the latter trial. I think that the polled investors are consciously placing the low bars so that 7977 can easily jump over the bar.
Any 7977 data coming out of EASL or any other sources are NOT reliable data because all ongoing trials are open label studies and there were no data for the SOC treated control to compare their results to.
So, if they get low 60s% for the Electron trial, can you imagine how high the VRTX price would jump? The results from Quantum trial would appear far better than 62% they expect because the trial includes the arm in which the dual combo was dosed 24 weeks unlike the Electron in which the combo was dosed for 12 weeks.
Read the ABT-450 EASL abstracts carefully. One abstract reports a study on IL28B CC allele patients (Incivek reports 100% cure for this group of patients). The contents of the other study are not internally consistent if they had chosen the naive patient group randomly as they should.
Any randomly selected naive patient group contains 55% of potentially SOC-(IFN/RBV) failing patients. Out of the 55% two third will be non-responders and one third will be relapsers. So, 55% x 2 /3 = 37% of naive patients should be non-responders. Now, only 47% of these 37% can be cured with Abbott's quad, and 53% of 37% would fail:
.53 x .37 = 0.196 = 20% = 100% - 80%
This means that even if all SOC responsive patients and relapsers are cured by the quad, the best SVR rate one can hope for is 80%, not 93-95%.
You see why there is this serious inconsistency in their data. One possibility is that their naive patients are not randomly selected and they don't represent the true naive population. Another possibility is their non-responder data were wrong.
But think about this: it is easy to cheat random selection than non-response selection. The latter is almost certainly the most difficult to treat by any protocol while a naive patient group can contain many diverse SOC-responders and there is a greater degree of freedom in selection particularly for a small (N<20) studies reported by Abbott.
The problem with analysts and investors expectation for HCV market is that they have come to expect 100% permanent cure rate with an all oral regimen. Recall that ABT's one oral regimen (2 compounds) announced on April 4 had a 91% SVR24 and a different two compound oral regimen had an SVR12 of I believe 93 and 95%. I thought those results were excellent and in fact bought some ABT shares that day. In addition to the fact that that news did not move ABT's stock, ABT's PPS is now below its April 4th price.
As I said the market was not impressed with that result because it was not 100%. Sometimes I think the investors and analysts expectations are absolutely unreasonable and totally off the wall.
I think though we may finally have some clarity and find out what a highly hyped all oral (7977) expectation for a cure rate is once and if GILD gives some reliable data for its 7977. It remains to be seen whether such reliable data will be available during EASL or whether we have to wait further for it to become available.