Bayer takes its heart-failure drug into Phase III after a mid-stage success

Bayer is pushing forward with a new heart-failure treatment that could eventually contend with Novartis' ($NVS) blockbuster-in-waiting Entresto, mapping out a wide Phase III program for its oral drug.

The pill, finerenone, is a next-generation mineralocorticoid receptor antagonist, or MRA, designed to block the production of bodily steroids that degrade heart function and lead to kidney problems. In a Phase IIb study on more than 1,000 patients with chronic heart failure, Bayer's drug beat out Pfizer's ($PFE) generic MRA Inspra in lowering rates of death and hospitalization, the company said. Patients in the study had both worsening heart conditions and either Type 2 diabetes or chronic kidney disease, populations at particular risk for cardiac events, Bayer said.

Now the German drugmaker is plotting three Phase III trials to confirm finerenone's promise, one on 3,600 patients matching the Phase II profile and two more enrolling 6,400 volunteers with diabetic kidney disease. Bayer hopes to extend the drug's run of Phase II successes and establish it as a safe, effective heir to older MRAs like Inspra, which are often underprescribed because of their ties to dangerously high potassium levels and kidney dysfunction, the company said. Finerenone, to date, has proved to be safer than its predecessors, according to Bayer.

The field of treatments for heart failure had been stagnant for years until Novartis hit a breakthrough with LCZ696, approved last month as Entresto. That drug, which combines the now-generic Diovan with a novel antihypertension agent, could bring in sales of more than $5 billion at its peak, analysts say, thanks to its ability to slash rates of cardiac death and hospitalization.

Bayer is at best years away from competing with its Swiss rival, but finerenone's steady progress falls right in line with the company's plan to keep up the pace of innovation after winning a string of approvals in recent years. Among Bayer's most promising pipeline assets is copanlisib, a Phase III PI3k inhibitor for lymphoma, followed by the Phase II cardiology drug vericiguat, partnered with Merck ($MRK).

Bayer is committing about €4 billion ($4.5 billion) to R&D in 2015, a roughly 5% hike over the €3.6 billion ($4 billion) it spent last year.

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