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Merck Blood Thinner Study Ends in Stroke Patients, Limiting Possible Sales
By Michelle Fay Cortez - Jan 13, 2011 7:58 AM MT

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Studies of Merck & Co.’s anti- clotting drug vorapaxar, a product analysts said may generate $5 billion in sales, were halted for patients with a previous stroke, potentially limiting its use.

Interim study results suggest the experimental medication, which uses a novel method to prevent platelets within blood from clumping together, isn’t appropriate for people who suffered a stroke, researchers at Brigham and Women’s Hospital and the Duke Clinical Research Institute said in a statement today. The trial was stopped by an overview board, the institutes said.

The drug was expected to generate peak sales of $5 billion or more a year for Whitehouse Station, New Jersey Merck, if the treatment is proved safe and effective, said Robert Hazlett, an analyst at BMO Capital Markets in New York. The drug is still in development for patients with a previous heart attack or blood clots deep in the legs. Merck declined $2.30, or 6.2 percent, to $45.85 at 9:55 a.m. in New York Stock Exchange composite trading.

The drugmaker previously said it plans to file for U.S. regulatory approval of the medication this year. The medicine is intended to prevent cardiac complications and deaths in patients with previous stroke, heart attacks, severe chest pain or blood clots in the legs known as peripheral arterial disease.

If approved, The drug would compete against the blood thinners Plavix from Sanofi-Aventis SA and Bristol-Myers Squibb Co., and Effient from Eli Lilly & Co.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
 












My guess is that in the secondary study there was a similar bleeding risk to what was illustrated in the triton study with effient. The other big question has to whether or not tracer was stopped early because the data was positive or due to lack of benefit. Let's hope it was stopped early like the esprit study because it was positive. However, I do worry that perhaps we may be in an early acs situation where adding on to the standard of care does not have any additional benefit. I hope I'm wrong.
 






My guess is that in the secondary study there was a similar bleeding risk to what was illustrated in the triton study with effient. The other big question has to whether or not tracer was stopped early because the data was positive or due to lack of benefit. Let's hope it was stopped early like the esprit study because it was positive. However, I do worry that perhaps we may be in an early acs situation where adding on to the standard of care does not have any additional benefit. I hope I'm wrong.

Given the way it's written, it's almost certainly a bad safety signal, rather than a lack of efficacy.
 


















The Merck management make the same mistake over and over. Merck simply cannot have a drug name start with letter V. Vioxx, Vytorin and now Vorapaxar. When I first saw the name Vorpaxar, I knew it's trouble.
 






This will be all about bleeding. Schering and then Merck both incorrectly talked about reduction of events without an increase in bleeding. Purposely misrepresented results of phase 2 results. All you had to do was look at the results of the 40mg dose in the phase 2 study to see that there was an increase in bleeding. Roughly +15% over plavix and asp. Sounds like prasugrel and ticagrelor to me. And that was in an small elective PCI trial of younger healthier pts. TRACER is in highier risk ACS pts who do what? Bleed more often of course! If approved, look forward to a black box warning. Ask the prasugrel reps how that has worked out for them.
 






























If the signal for V is as bad as this looks, Katie Bar the Door!

Merck will have about 5 more years as a relevant research organization, then go the way of Pontiac, Compaq, DEC, Enron, and the rest.

Merck's slide into oblivion has one and only one cause: positive thinking is more important than critical thinking. The critical thinkers are routinely chased off because they fail to join the collective and worship with wonder the emperor's new clothes.

Sad, sad, sad. I will be gone in 12 months.
 






Fred Hassan made a fool of MERCK MANAGEMENT

As a former SP employee who was fucked out of a job last May, Fred and all SP senior management fucked Merck with a bogus pipeline. We tried to warn you but SP got rid of us who knew to much....So how well are the other primary care products doing? If your a sales rep you know..doing shit hahahahaha
 






As a former SP employee who was fucked out of a job last May, Fred and all SP senior management fucked Merck with a bogus pipeline. We tried to warn you but SP got rid of us who knew to much....So how well are the other primary care products doing? If your a sales rep you know..doing shit hahahahaha

Got fucked too, didn't even enjoy it! Good luck with this one, not only is the data bad, Merck got rid of most of the Cardiology sales force, the ones who really could sell and spin this. Maybe it could go to the Neuro sales force they're doing such a great job with Saphris. LOL
 






This is the greatest thing ever. I was a Smerck ex employee who worked on other studies but they made TRA such the favorite child. So they gave them the power to immediately be anyone's top priority at the drop of a hat. Due to that other studies hit delays or had to go out source which cost more money. Lets not even get into the praise and i am sure dollars thrown at people on those studies. This is just what both companies deserve, but what do you expect from a hassan job or sorry meant hacket job.
 






Got fucked too, didn't even enjoy it! Good luck with this one, not only is the data bad, Merck got rid of most of the Cardiology sales force, the ones who really could sell and spin this. Maybe it could go to the Neuro sales force they're doing such a great job with Saphris. LOL

great point. merck used to have a presence in cardiology w/statins,aces,arbs. merck is now nothing in cardiology. come to think of it,name me a therapeutic category were merck has a presence. thinking. thinking. thinking...
 












If the signal for V is as bad as this looks, Katie Bar the Door!

Merck will have about 5 more years as a relevant research organization, then go the way of Pontiac, Compaq, DEC, Enron, and the rest.

Merck's slide into oblivion has one and only one cause: positive thinking is more important than critical thinking. The critical thinkers are routinely chased off because they fail to join the collective and worship with wonder the emperor's new clothes.

Sad, sad, sad. I will be gone in 12 months.

Lucky you! Assuming you will be 55 then... Let's hope "Mother" doesn't lay you off; or, worse, PIP you before then. As long as you get a severance, it will be OK...actually, it will be great:)