With A New Class Of Lipid-Levels Management Biologics Arriving — Will Merck’s Zetia® Soon Lose Her Voice?

UPDATED | @ 9 PM EDT: A great comment, this is Anon.! “. . . .Small circle & arrow to insert here, Condor. Regeneron, the partner development company here, is home to none other than P. Roy Vagelos. Dr. Vagelos was the last scientific CEO of Merck. Isn’t it ironic?

October 16, 2013 at 8:32 PM. . . .”

Ironic indeed, Anon! First, the caveats: it is only a smallish 100-or-so patient study. Second, the much larger outcomes study is still enrolling. Even so, this new class of biologic injectible cholesterol management drug will likely soon eat Zetia’s lunch. Putting aside all the controversy surrounding Zetia’s [non-]outcomes data, we will soon have a completely different mechanism of action, in the space, on-market. A big old honkin’ biologic chain/molecule, to be sure — but all new.

[For more background on the race to bring AlirocumabTM to market, see mine, from the past Summer.] While Zetia® may turn out to be Merck’s No. 2 overall seller this year (as other Merck blockbusters go generic, and fall off), Zetia has been, since 2008, a much-diminished diva, in the Kenilworth to Whitehouse Station (and back to Kenilworth, again!) opera house. Here is a bit of Yahoo! News, on the Sanofi S.A.-Regeneron program successes, with Alirocumab:

. . . .A new type of cholesterol drug being developed by Regeneron Pharmaceuticals Inc and Sanofi SA, when used by itself, cut levels of “bad” LDL cholesterol almost in half in the first of a dozen late-stage trials of the injectable medicine.

The experimental drug, called alirocumab, is from a promising new class of injectable cholesterol fighters also being developed by Amgen Inc and other drugmakers. They work by blocking a naturally occurring protein called PCSK9 and could each garner annual sales of $3 billion or more, if approved, according to some industry analysts. . . .

We will keep you posted — exciting times — in the advancement of medicine! [With the government closed, I cannot access the PubChem database’s online molecular structure-drawing tool, so no graphical depiction of that monster of a structure, for now. Thanks again, Speaker Boehner — and Tea Party zealots!]


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