While it seems to have the less-potent candidate, Roche is over a year and a quarter ahead of Merck, in getting its large (potentially FDA approvable) CETP inhibitor study underway. Roche has been enrolling patients in its 15,000 patient study since last fall. Roche’s CETP candidate is called Dalcetrapib. Merck has said that the 30,000 patient REVEAL study will begin enrolling in early 2011. That is significant.
Doubly so, given that Dr. Thomas Lüescher’s Anacetrapib (DEFINE study results at AHA in Chicago, on Tuesday past) slide number 13 openly admits that it is unknown whether the HDL particles — modified and enlarged by the Anacetrapib regimen — are even biologically viable. That is, it is unknown whether they function the way normal HDL would — at all.
This show is at the first intermission, per GeigerCount.com’s Greg Miller — do go read it all:
. . . .Medical history, while happening in front of the public’s eyes, is rarely noticed. . . .
[Pfizer’s 2006] torcetrapib failure created huge gaps in Pfizer’s planning. . . .
In the meantime Merck and Roche geared up clinical trials with their versions of CETP inhibitors. Merck was catapulted to the lead position with anacetrapib, closely followed by Roche with dalcetrapib, which they received through a joint venture with Japan Tobacco’s pharmaceutical unit. LaMattina was also wrong with asenapine [Editor’s Note: More on that story (asenaping | Saphris | Sycrest) in a coming Sunday-morning post — paging Salmon! STAT!]. . . .
In fact, Roche initiated a large 15,000 patient trial using dalcetrapib in November 2009, whereas Merck only mentioned “a large cardiovascular clinical outcomes trial” using anacetrapib in a November 17, 2010 press release. Merck has the more potent CETP-inhibitor, however, given the complexity of lipid biology, that might not necessarily be the winning criteria as a more potent CETP inhibitor may not necessarily result in a superior clinical benefit. The race to the first approved CETP inhibitor will be decided between Merck and Roche, as no other company is known to conduct clinical trials with CETP inhibitors. If history is the guiding principle, Merck might win the first CETP inhibitor approval; and another company, perhaps Roche this time, might get the best selling CETP inhibitor. When Merck in the 1980s was following Sankyo in developing a statin to lower cholesterol and then Sankyo discontinued its clinical development, Merck brought lovastatin (Mevacor) as the first ever approved statin across the finish line in 1987. Sankyo, not giving up, partnered their next generation pravastatin with Bristol-Myers Squibb and received FDA approval in 1996 for Pravachol. However, Pfizer, who initially did not participate in the statin race, acquired then Warner Lambert’s statin which became the world’s best selling drug Lipitor. . . .
Do stay tuned. I know we will — and do go read Greg Miller’s prodigious report, cover to cover.