The data aren't out yet, but the buzz about Novartis' ($NVS) new late-stage contender for blockbuster status is growing to fever pitch. This morning Leerink opted to add on $3 billion to the pharma giant's forecasted revenue for 2026, concluding that LCZ696 has the distinct potential of becoming a mainstay therapy in the prevention of cardiovascular deaths--even substituting for the generic ACE inhibitors that now dominate the market.
The pharma giant captured the cardiology world's attention when it announced that a pivotal study for the drug had been halted early on based on its success regarding mortality and hospitalizations when compared to the generic Vasotec. Not willing to wait for the data, analysts have been doing their own number crunching, concluding that the data monitoring committee's decision foretells this drug's ability to conquer an enormous market.
In order to hit the demanding p value laid out for the study, Leerink concluded that the data board had to see a reduction in cardiology deaths of 20% or more. That kind of response could set it up as a new standard of care. "With 6-7M CHF patients in the U.S. of whom ~35% are class II-IV HF-REF patients, LCZ696 could become a major new treatment option in a potential multi-billion dollar market."
This for a drug that many analysts had concluded was a long shot at best.
It couldn't have happened at a better time. Novartis had cast serelaxin as the next-gen heart drug that would step up as generic competition chopped up the Diovan franchise. But those high hopes have been dashed by repeated bashing at the hands of regulators and FDA advisors in the U.S. and Europe. Now, Novartis has a new story to tell.
In an influential piece for Forbes.com, which Leerink cited in its analysis, Larry Husten, a medical journalist who specializes in cardiology and blogs at CardioBrief, clearly laid out the argument in favor of a new frontline therapy for heart disease.
Milton Packer, the co-principal investigator of the study, told Husten that investigators tracked a highly statistical reduction in cardiovascular mortality in the drug arm when compared to a group taking ACE inhibitors. Brigham and Women's Marc Pfeffer followed with the assessment that the DSMB's decision indicated that the final results "will be both definitive and important."
Cardiologist Clyde Yancy, a top investigator in the field and former AHA president, told Husten: "Potentially this is of incredible importance and could really be the breakthrough moment we've been seeking for some time. There has been an ongoing question of whether or not we could ever challenge the primacy of ACE inhibitor therapy in heart failure."
When thought leaders of this caliber speak, analysts listen. But we're talking about heart disease here, where regulators will set the bar on safety very, very high. Husten recalls the case of omapatrilat, a Bristol-Myers ($BMY) drug that looked a lot like LCZ696. It turned out that the drug triggered angioedema. And while there are no signs yet that Novartis' therapy has the same Achilles' heel, there's always the chance of a clinical disaster.
The sudden and unexpected drubbing that awaited serelaxin will still temper many analysts' enthusiasm for LCZ696. But barring another nasty surprise, the tide has turned back to Novartis' favor.
- here's the article from Forbes.com