Tuesday, January 27, 2009

Compare and Contrast: Vertex Extends Next-Gen Hep C Lead Over Schering

First, consider this, from Schering's announcement of today:". . . .Treatment discontinuations due to adverse events were between 9 and 19 percent for patients in the boceprevir arms, compared to 8 percent for the control arm. . . ."

See this -- dated January 12, 2009 -- from Vertex's Investor Relations crew. I've excerpted a snippet below, to outline just how far ahead Vertex's Teleprevir is -- relative to this morning's Schering-Boceprevir announcement:

January 12, 2009

. . . .Broad Clinical Development Program for Telaprevir

ADVANCE and ILLUMINATE trials in treatment-naive patients fully enrolled

Vertex today announced that the ILLUMINATE clinical trial is fully enrolled. Together with the ADVANCE clinical trial, which was fully enrolled in October 2008, Vertex has enrolled more than 1,500 genotype 1 treatment-naive HCV patients as part of the Company's broad registration program for telaprevir:

ADVANCE: Vertex and Tibotec completed enrollment in October 2008 in the global 3-arm pivotal Phase 3 ADVANCE trial that is focused on 24-week telaprevir-based response-guided regimens in genotype 1 treatment-naive HCV patients. In the ADVANCE trial, telaprevir is being dosed for 8 or 12 weeks. All patients are expected to have completed 8 or 12 weeks of dosing with telaprevir or placebo by the end of January 2009. Vertex expects to have sustained viral response (SVR) data from the ADVANCE trial in the first half of 2010. The ADVANCE trial enrolled approximately 1,050 patients.

ILLUMINATE: Vertex today announced that the Company has completed enrollment in the global 2-arm ILLUMINATE trial that will include evaluation of 24-week and 48-week telaprevir-based regimens in genotype 1 treatment-naive HCV patients. In the ILLUMINATE trial, telaprevir is being dosed for 12 weeks. The Company expects to have SVR data from the ILLUMINATE trial in the first half of 2010, which will supplement SVR data obtained from the pivotal Phase 3 ADVANCE trial. The ILLUMINATE trial enrolled approximately 500 patients.

Differentiated profile in treatment-failure patients

Full enrollment of approximately 650 patients in the global 3-arm pivotal Phase 3 REALIZE clinical trial is expected in the first quarter of 2009. This trial is focused on 48-week telaprevir-based regimens in genotype 1 HCV patients who failed to achieve SVR with prior treatment of pegylated interferon (peg-IFN) and ribavirin (RBV). The REALIZE trial is expected to enroll relapser, partial responder and the most difficult to treat null responder patients who are well-documented with respect to their prior response to HCV therapy. In the REALIZE trial, telaprevir is being dosed for 12 weeks.

Vertex presented interim clinical data, including safety information, from the Phase 2 PROVE 3 trial in November 2008 at AASLD. The data showed a 52% SVR12 rate in treatment-failure HCV patients, with a 24-week telaprevir-based treatment regimen. All patients in PROVE 3 completed dosing in the second quarter of 2008. Vertex expects to present final SVR data from the telaprevir and control arms of PROVE 3 at a medical meeting in the first half of 2009.

Vertex exploring utility of telaprevir in other patient populations and dosing regimens

Interim results presented in November 2008 from the ongoing, Phase 2, open-label, randomized C208 study examining a twice-daily (q12h) telaprevir dosing regimen versus a three-times-daily (q8h) regimen in combination with RBV and peg-IFN-alfa-2a (PEGASYS(R)) or peg-IFN-alfa-2b (PEGINTRON(TM)) in treatment-naive genotype 1 HCV patients, including safety information from the study, support the potential for twice-daily dosing of telaprevir. Tibotec expects to present additional data from this trial, including SVR data for patients who completed dosing and have been followed 24 weeks post-treatment, at a medical meeting in 2009.

Vertex and Tibotec plan to discuss a proposed HIV/HCV co-infection program with the U.S. FDA and European health authorities in the coming months. . . .

It is clear, from Schering's own press release of this morning, that Boceprevir has fallen well-behind. But most-importantly, do note that Schering's adverse event rate is much higher that the comparable Teleprevir rates. Irritations caused by Schering's molecule may well end the race early -- with a forefeit win for Vertex. Do stay tuned. Back now.

I should point out that, in earlier press-released study results, Vertex's Teleprevir showed much higher effectiveness rates (vis-a-vis Schering's Boceprevir) in patients whose previously-attempted treatments for Hep C had failed. Schering's release (of today) confirms this data -- Vertex's Teleprevir is doing much better at treating the so-called "non-responders" -- those who did not acheive significant reductions in their viral loads, during prior courses of therapy, with a variety of other compounds (including Schering's).

My bet? Teleprevir is going to be declared "best in class" -- for the next generation of Hep C drug candidates.

And that alone puts Teleprevir a full quarter-mile ahead of Schering's Boceprevir -- in a two-mile race.


Anonymous said...

As some companies say:

Either first to market or best to market.

Otherwise forget it.

That doesn't mean SP should give up you never know what problems may befall the other guy and knock them out of the running. However if you want to bet your money.


Condor said...

Right. And it looks -- right now -- like Schering's will be niether.

In fact, there may be several candidates that will beat Boceprevir to market, and at least one -- Vertex's Teleprevir -- is showing vastly superior efficacy.

Thanks, as ever, Salmon!


Anonymous said...

What I don't understand: the bocep follow-on requires ritonavir, and that's the last thing that hep patients should take.

Anonymous said...

unfortunately for some of us who are nonresponders to the peg/ribo treatment this may all come too late. Not sure if i will be able to wait much longer.

Anonymous said...

i wonder why boger is stepping down, a very highly respected and ethical man? and now they have emmens to fill the role (a very political, savvy, people-pleaser)? could it be that vertex has bad news on the horizon?? hmmmm, indeed i believe.

Condor said...

I missed this comment until now -- with the passage of time, though, it seems the new CEO is more experienced in bringing a sales force "online", in multiple geographies, and quickly -- less a "development" guy, and more a "commercialization/lauch/post-launch" tool-kit.

Makes sense with a mid 2010 FDA NDA filing (quite likely) looming.