From today's press release (delivered into the opening of the J.P. Morgan Healthcare Investor Conference -- at which Merck's presentation will be protested) -- clearly, Vertex is well-ahead of New Merck's boceprevir (a legacy Schering-Plough Hep C candidate):
. . . .Vertex plans to submit a New Drug Application (NDA) for telaprevir in the second half of 2010 for both treatment-naïve and treatment-failure patients. . . .
Vertex has assembled a global supply chain network to support the potential launch of telaprevir and is currently manufacturing telaprevir at a commercial (metric ton) scale. The company has successfully completed all registration campaigns as well as validation campaigns of the active pharmaceutical ingredient (API) and is prepared to complete drug product validation in advance of the potential launch of telaprevir. . . .
"Phase 3 data for telaprevir, our lead drug candidate for the treatment of hepatitis C virus infection, will begin to emerge in the spring of 2010 to support the planned submission of a New Drug Application in the second half of this year. Our more than decade-long commitment to improving patient care in HCV is unwavering, and the Phase 3 program for telaprevir will remain our primary focus over the coming year. Importantly, we also recognize the need for continued innovation in the treatment of this disease, and we are preparing to initiate the first clinical trial combining telaprevir with the investigational HCV polymerase inhibitor VX-222 this quarter," stated Mr. Emmens. . . .
3 comments:
Where exactly do you get your information that Vertex is "well ahead" of SP/Merck? The Boceprevir trials have also completed dosing and they should be able to file by the end of the year as well. Just because they don't keep tooting their own horn doesn't mean they aren't right there. You also underestimate the fact that the people working on boceprevir have past history in getting drugs approved in this disease, while the Vertex people have no such experience. The turtoise is going to win this race.
Well -- let's start with comparative efficiacy:
There, telaprevir is a hands-down winner. It is curing over half of the prior non-responders. I firmly believe FDA will take notice of this.
Second, it is well-ahead in cure rates (or SVRs if you will) -- in untreated Hep C patients. [See Goldman Sachs' latest research report on VRTX, for more; note also that Goldman does not rate Merck as a "convicted buy" at the moment -- but it does so rate VRTX.]
Finally, Vertex has a partner in J&J -- I think they've shown (especially of late -- last three years) a stronger track record of winning approvals than legacy Schering-Plough.
With New Merck now finishing up the research on boceprevir, FDA will likely see that (exit of SGP) as a mild positive, compared to old Schering-Plough -- but it will not overcome telaprevir's superior efficacy data.
Those of us who've been around more than a while know (from long experience) that FDA will move pretty quickly for a truly revolutionary new agent -- and telaprevir has all the earmarks of being just that.
To be clear -- I do not own either name, nor am I short either.
I just see a decidely-better drug -- in telaprevir.
Your mileage aparently differs.
That's all cool by me.
Good luck, and Namaste
According to trial data and timing, Merck can possibly file earlier with a limited indication in patients who failed treatment. Question is if FDA will approve, and that is the big unknown.
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