Sunday, August 21, 2011

Roche's Dalcetrapib -- Next Two Phase II Hurdles -- In Paris, This Weekend

These study results are due on the same class of HDL-increasing agents that Merck is about two years behind Roche in working on. Everyone is hoping to see HDL (the "good" cholesterol) increased, and some measure of arterial plaque reduced, in the two studies offering top-line results this weekend in Paris, France -- at the 2011 European Society of Cardiology Congress. And concurrently, eveyone will be hoping to not see the heart-attack side effects that Pfizer experienced in 2006 with torcetrapib. [My earlier background on it is here, here, here and here.]

Here's a bit of the Bloomberg reporting, on Roche's news -- do go read it all:

. . . .Interim results from the 15,800-patient trial are expected early next year, with a first set of final results by December 2012, Pascal Soriot, Roche’s pharmaceutical unit head, said in a conference call with analysts on July 21.

Still, Cannon said, “if plaque shrinks, that is a huge win and very exciting, and everyone is going to be jumping up and down saying, ‘Hurray, this class works.’” An abstract of data for the dal-Plaque study is scheduled to be posted on the conference website tomorrow. Dal-Vessel is due to be presented in an oral session on. . . [this Saturday].

Eli Lilly & Co. and Merck & Co. have similar drugs in development aimed at increasing good cholesterol, or HDL, in the bloodstream.

HDL flushes fat deposits from arteries to the liver to be eliminated from the body. By contrast, statins such as simvastatin and Pfizer’s Lipitor, the best-selling drug in the world, decrease levels of bad cholesterol, or LDL, which blocks arteries and leads to heart attacks. . . .

“It’s a high-risk project, because what we want to know is that HDL has a positive effect,” Schwan said. “Nobody has proven this yet. I always say dalcetrapib is the biggest proof- of-concept study we ever did.”

In a conference call with analysts in 2010, Schwan said the drug had the potential of “rewriting the textbooks in cardiovascular medicine” and named the pill among a group of medicines with potential for more than 5 billion francs ($6.3 billion) in sales, according to the call transcript. He declined in July to elaborate on the sales potential for the drug. . . .

Keep your fingers crossed -- for all patients struggling with cholesterol management.

So -- what's on your plate this week? Tell us -- in the comment box.


Anonymous said...

I guess I just want to remind you that atatins and cholesterol levels aren't necessarily the important factors everyone makes them out to be:

"Statins for the primary prevention of cardiovascular disease." Cochrane Database Syst Rev. 2011 Jan 19;(1):CD004816.
Taylor F, Ward K, Moore TH, Burke M, Davey Smith G, Casas JP, Ebrahim S.

Condor said...

Fair enough.

And a good perspective to keep in mind.