The European Society of Cardiology meeting has produced a burst of news on some major market heart drugs.
Eli Lilly's Effient disappoints in head-to-head with Plavix
Eli Lilly's hope of improving on weak Effient sales with an expanded approval was dealt a harsh setback over the weekend as investigators revealed that the heart drug had failed a head-to-head study with Plavix among a broader group of patients who rely on medication to control their condition.
Lilly ($LLY) and partner Daiichi Sankyo produced data on Effient that nearly matched Plavix on the number of cardio deaths, heart attacks and strokes in a group of patients who didn't require a stent or bypass surgery to control acute coronary syndrome, or ACS. But investigators were pleased to see that Effient, which has raised concerns about bleeding, also had the same safety profile as Plavix. And a lower risk of adverse events after 12 months of therapy held out the hope that further studies would show an improved safety profile for long-term therapy.
As Reuters notes, though, Effient sales have failed to live up to initial expectations. And investigators had been operating with a set of data that already indicated that the drug should have offered solid efficacy over Plavix, making the head-to-head failure a significant disappointment for Lilly as generic competition eats into its bottom line.
- get the press release
- here's the Reuters story
Novartis collects promising biomarker results in PhII heart study
One of Novartis' ($NVS) heart drug prospects produced some promising biomarker-related data for heart failure, clearing the way for much larger trials ahead.
Investigators say that LCZ696 significantly reduced levels of the protein NT-proBNP after 12 weeks of study in Phase II. That's important because the biomarker is a key indicator for patients with preserved ejection fraction, a condition that afflicts half of the huge patient population in the U.S. and Europe. And investigators say they picked up signs of a positive structural change that should be followed up in Phase III.
While positive, a biomarker study for a heart condition like this will need to be tested in a big Phase III program to deliver clear signs that the drug can help heart failure patients without setting them up for an increased risk of adverse events.
"These Phase II results show that this novel treatment approach has the potential to reduce stress to the heart and to reduce enlargement of the left atrium of the heart, which occurs in patients with heart failure," said Dr. Scott Solomon, a professor of medicine at Harvard University.
LCZ696 is a new molecule created from the combination of AHU377--similar to Bristol-Myers Squibb's ($BMY) omapatrilat, which was scuttled by safety issues--and Diovan. The drug is designed to spur the body's natural ability to reduce blood pressure.
- here's the press release
- read the report from Reuters