|Novartis Pharma Chief David Epstein|
Novartis execs all the way up to CEO Joe Jimenez have already expressed just how delighted they are in the Phase III efficacy data that's been emerging about the heart failure drug LCZ696. This afternoon, their enthusiasm in the would-be "multiblockbuster" was supported by the addition of some promising pharmacoeconomic data--particularly in cutting the need for acute care.
Investigators have already noted a 20% reduction in the risk of dying--the key measure behind a full slate of upbeat peak sales estimates. The pharma giant's ($NVS) biggest challenge now is living up to some heady expectations. And today we learned that there was also a 30% drop in ER visits, a 16% overall slide in hospitalizations as well as a significant reduction in the need for intense therapy at home when compared to patients taking the ACE inhibitor enalapril.
When hospitalized, Novartis reported, "LCZ696 and enalapril patients remained under care for approximately the same time, but those on LCZ696 had 18% fewer stays in intensive care and were 31% less likely to need IV drugs to help their heart pump. Patients' reports of how well they felt and doctors' assessments of disease severity were also significantly better with LCZ696 than enalapril."
Add it all up, says David Epstein, division head of Novartis Pharmaceuticals, and there's a growing body of evidence that this drug can "reduce or slow the decline in their heart function, potentially altering the progression of their disease." The new numbers are being reviewed at the annual meeting of the American Heart Association (AHA).
Novartis needs all the upbeat pharmacoeconomic data that it can get on this drug. The company has to put significant clinical distance between its new treatment and the cheap generic enalapril. Analysts estimate that Novartis could charge $7 a day for LCZ696--more than many people's copay for a month's worth of generics.
Designed to be taken twice a day by a massive group of patients suffering from chronic heart failure, the treatment is a dual-acting angiotensin receptor-neprilysin inhibitor, taking a one-two punch with valsartan and AHU-377. AHU-377 blocks a mechanism of action that threatens two peptides responsible for lowering blood pressure while valsartan improves vasodilation, spurring the body to excrete sodium and water.
LCZ696 has been living up to its rep as the next big thing in Novartis's cardiovascular pipeline--a big factor in getting over the profound disappointment caused by the failure of serelaxin with regulators.
"I've done many trials, and you just don't get things that look like this," says principal investigator John McMurray, a professor at the University of Glasgow. "Every single measure we looked at, we did something good."
The clinical work for this drug is being divided into two basic segments, says McMurray. This first part covered at the AHA involves prompting the heart to contract and empty more normally for heart failure patients. The next step, to be covered in an upcoming trial, will examine its ability to complete another essential task for the heart muscle: relaxation and filling.
An initial approval for this drug would open up a huge and growing market in the heart failure field. But further success has the potential to make this drug a player in the lives of 75% to 80% of the entire patient population, says the investigator, one reason why Novartis execs are estimating peak sales at $5 billion or more.
Investigators had to compare their new drug with a standard of care for patients. But by extrapolating data from enalapril, they found a "really impressive 32%-34% reduction in cardio mortality and a 45%-50% reduction in hospitalizations."
- here's the release