Tuesday, August 16, 2016

The Last Of "Fast" Fred's "Five Stars" Falls: Merck's Zontivity® Is Done, In US

FiercePharma has done a very nice job of covering this long-developing story, while I've been attending to other matters.

I'll just quote some of theirs, and point you to mine -- of May of 2014, when it was approved in the US with a very narrow label. At least two other strong competitors have come on market (and three more are about to) -- in the US -- since May of 2014. [Prior to May of 2014, Merck had already written off some $1.7 billion on the project -- so this brings the total impairment charges to almost exactly $2 billion, over about five years, or $400 million per year. Ouch.]

Of course, our hearts go out to those families whose incomes and careers are ending here. We will keep them in our morning meditiations. But in truth, this one had long been expected. Here's the FiercePharma item, and a bit:

. . . .Merck acquired Zontivity, or vorapaxar, in its 2009 buyout of Schering-Plough. It was a first-in-class PAR-1 drug designed to compete with the old standby clot fighter warfarin in stroke patients, and analysts had pegged its peak sales as high as $5 billion per year.

But as clinical studies progressed, serious bleeding risks emerged, dashing hopes of an approval for stroke patients and limiting its potential market. Its 2014 approval included a “black box” warning about those bleeding risks. . . .

Since then, newer clot-fighters have hit the market, including AstraZeneca’s Brilinta, approved for post-heart attack treatment, and Eli Lilly’s Effient. There’s also a range of next-gen warfarin rivals, including Bristol-Myers Squibb and Pfizer’s Eliquis; Johnson & Johnson and Bayer’s Xarelto; and Boehringer Ingelheim’s Pradaxa. Those drugs have bleeding risks of their own, but reversal agents are nearing the market. . . .

Now you know -- and I do think that is the last of Fred's five favorite candidates -- from the 2008 era. Not one made anything near what Mr. Hassan was literally pounding the table claiming it would. Onward, on a glorious late summer afternoon just the same -- off, to the pop-up farmers' fresh fruit stands, here in the city, on foot. . . . smiling ear to ear.


Anonymous said...

Interesting. Just happened to check in.

The story has not ended.


Condor said...

Ah, Salmon -- it has been quite a considerable stretch of time, since both stood waist deep in the same icy river. . . Waiting for a meal to rise.

And as it is with all the true black Irish, the story never really ends -- but our voices do deepen an octave or two, over decades. Grin.

Hoping you are well, and traveling light, man!


Anonymous said...

This was a boondoggle from the outset. SGP built its entire case on pre-clinical data alone (that there would be no additional bleeding risK) and then rolled the dice on 2 very large clinical outcomes trials. Fail.

At the time commercial colleagues would ask me why the scientific leaders and knowledge experts kept telling them that there was "no free lunch" in terms on inhibiting thrombosis. After explaining the biochemistry to them, and agreeing with the experts, I was told that I clearly didn't know what I was talking about as the company must know what they're doing.