With its top experimental heart drug serelaxin being pounded mercilessly by regulators on two continents, Novartis may have found a second heart drug act that promises a blockbuster ending. The pharma giant ($NVS) announced that the data monitoring committee has hit the green light for any early close to the pivotal study for its new blood pressure treatment LCZ696 after investigators tracked delays in cardiovascular deaths and fewer hospitalizations resulting from heart failure in comparison to Vasotec, a generic blood pressure medicine that has been around for years.
LCZ696 is a combination of Novartis' Diovan and the experimental AHU-377, designed to bolster peptides that help reduce blood pressure. The news--including top-line results only, with data to be released later--couldn't have come at a more fortuitous time. Analysts have been fretting over Novartis' ability to replace its revenue from Diovan, especially as serelaxin looks like it will be held up for a considerable amount of time in order to undergo another major study.
Now Novartis has helped change the narrative. Tim Anderson, a high-profile analyst at Bernstein, is buzzing about a timeline that puts LCZ696 on track to an approval next year. And the company is positioning the drug as a front-line therapy for a huge and growing population of patients suffering from chronic heart failure.
"In terms of nearer-term competitors behind LCZ696 within the ANRI class, we are aware of none," says Anderson in a note to investors. "This suggests that, if full results are robust, LCZ696 could represent another blockbuster drug in the category of cardiovascular medicine that the company knows well."
But after the serelaxin debacle at the hands of regulators at the FDA and in Europe, Novartis has a credibility issue on its hands that is reining in some of the enthusiasm. Anderson notes that Novartis had also sounded a bullishly optimistic note on serelaxin, only to see its argument buckle under careful scrutiny. Now more analysts will want to see the actual data before they fully subscribe to the company's PR offensive.
And Novartis is holding nothing back in touting this contender, which has had a very low profile at the drug giant until today.
"The results of PARADIGM-HF are truly impressive" said Dr. Milton Packer, a principal investigator, in a prepared statement. "The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure."
The news came straight from Basel as investigators around the world were wrapping up the big scientific meeting of the American College of Cardiology.
- here's the release