Tuesday, October 13, 2015

Updated & Added Analysis -- From Lilly's CETP Inhibitor Disappointment -- Amgen/Dezima/Roche/Merck Edition

After the Cubs' long-ball fest of last night (yes!), I took a little time to read up on other CETP candidate programs, their owners (old and new), promoters and detractors. In doing so, I revisited this one (circa February 2015), from the same Forbes pharma blog author who effectively declared the class dead, yesterday (disclosure: he's an ex-Pfizer guy, and he lived through Pfizer's CETP flameout -- which was a safety signal, unlike Lilly's). So, I get his skittishness. And he may turn out to be right -- but I don't think Merck (or Amgen, or to a lesser degree, Roche) has the data yet, to make that call.

In February of 2015 that Forbes author was newly extolling the CETP thesis as a DNA-personalized medicine -- for cholesterol -- and speculating (built on the speculation of others) that perhaps the whole class would be revived by such an approach. There was even talk of a restart at Roche -- which had exited in 2012.

However, as of yesterday, the author was looking askance at Amgen's payment of $300 million for Dezima -- which won Amgen the right to develop a CETP inhibitor Dezima owned. [That CETP candidate was initially called TA-8995, and later renamed to DEZ-001. If memory serves, Dezima, in turn, had acquired those TA-8995 candidate rights, from Bristol Myers Squibb, some years earlier.]

In any event, even though the estimable Dr. Steve Nissen (of the Cleveland Clinics) is saying that the whole class may be non-effective, I think we should wait just a beat -- to see what really comes from the final Lilly disclosures -- at clinicaltrials.gov. I am sure Kenilworth will be scouring those e-documents, as soon as they are available. In the mean time -- let me take you back to one other thing the ex-Pfizer gent wrote in February 2015, which probably rings true, even after yesterday's Lilly disappointment:

. . . .Merck is also facing another challenge. Even if REVEAL [Merck's large CETP study] is successful, the potent LDL lowering PCSK-9 inhibitors that are racing to the market from Amgen, Sanofi/Regeneron and Pfizer will likely already be on the market when the REVEAL results are in hand. If the PCSK-9 inhibitors are as successful as envisioned, will anyone care about a CETP inhibitor?. . .

That's a fair point, indeed. Now. . . close 'em Cards out, at 4:30 EDT, you North-Siders. . . smile! Onward.

1 comment:

Anonymous said...

The PCSK9 inhibitors are biologics and are priced as biologics. They also have a very narrow indication. A CETP inhibitor will be far cheaper and will likely have a much broader indication. So, yes, there is room for CETP inhibitors in a PCSK9 inhibitor world. Put another way, CETP inhibitors could be seen as adjuncts or add-ons to statins. PCSK9 inhibitors are unlikely to be seen in the same light.