Bleeding risk clouds Merck’s hopes for vorapaxar franchise

Posted under Blog, cardiovascular risks, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Startups, Universities, Videos, vorapaxar, Warfarin by John Carroll

Vorapaxar isn't shaping up to be the mega hit that Merck ($MRK) had hoped for. Once billed as a promising successor to warfarin, Merck was left to explain marginal benefits and a serious added risk of bleeding for patients. And some analysts were left to speculate that the drug may never make it to the hands of sales reps.

Dr. David Morrow of Brigham and Women's Hospital in Boston told the gathering at the American College of Cardiology that 11.2% of the patients taking vorapaxar experienced a cardiovascular event, such as heart attack, stroke or death, compared to 12.4% of the patients in the control arm. Here's the killer, though: 4.2% of patients taking vorapaxar experienced moderate or severe bleeding, compared to 2.5% in the control arm receiving standard of care plus a placebo.

The investigators zeroed in on a large group of patients with a history of heart attack, tracking a net benefit that could open a path to an approval. Now Merck has to decide for itself where it takes the program from here. 

Merck knew that it had a problem on its hands at the beginning last year, when troubling safety data forced investigators to stop using the drug to treat patients with a history of stroke. But despite the mixed results and continued problems with bleeding, Merck--which paid $41 billion for Schering-Plough in part to get its hands on the drug--still sees the glass more half full than half empty.

"We are extremely excited by the results," Francis Plat, Merck's head of cardiovascular clinical research, told Reuters. "This is a positive trial." Some analysts, though, have already zeroed out any expected earnings from the pill.

- get the press release
- read the Reuters story
- here's the AP report

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Merck tracks positive results, bleeding risk in second big vorapaxar study

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Schering-Plough, Startups, Universities, Videos, vorapaxar by John Carroll

Merck says that vorapaxar, its troubled blood thinner once considered the jewel in Schering-Plough's crown when the pharma giant bought it for $41 billion, hit its primary efficacy endpoint in a second major late-stage study. But Merck ($MRK) investigators also noted that while the drug--which proved too dangerous to continue the first study to its conclusion--looked positive on the top line, patients taking it also suffered from a significant increase in bleeding.

Vorapaxar has caused a lot of trouble for Merck, which once hoped that it had a blockbuster treatment on its hands when the deal for Schering-Plough went through. A year ago the company shut down the first big study after investigators tracked a dangerous increase in the risk of bleeding.

In this second study, TRA-2P, researchers were testing the treatment using a composite score for cardiovascular death, heart attack and stroke, paying particular attention to whether it would prevent clots. The data will be reviewed in March.

"In developing vorapaxar, Merck and our scientific collaborators set a very high bar--would the addition of vorapaxar to standard of care provide incremental benefit in preventing clots?" said Peter S. Kim, president, Merck Research Laboratories. "We are pleased that TRA-2P met its primary endpoint, and we look forward to discussing the results with the scientific community."

So where does it go from here? For Merck's part the pharma company says it will ponder all the data and then consider its options, including a potential regulatory filing. With one monumental pratfall and mixed results for the second study, plenty of questions beg to be answered first.

- here's the press release

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Merck’s vorapaxar failed to beat placebo in key PhIII

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Startups, Universities, Videos, vorapaxar by John Carroll

Investigators for Merck unveiled some of the data from their failed late-stage study of the experimental blood thinner vorapaxar, noting that 18.5% in the drug arm experienced a cardiovascular event, compared to 19.9% in the placebo arm. Also, more patients in the vorapaxar arm of the study experienced hemorrhagic stroke. Merck says it will need data from a second study due next year before investigators can determine whether to continue work on the drug. Report