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Novartis' heart failure drug faces hurdles despite upbeat PhIII results

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Novartis has detailed the hits and misses from a late-stage trial of its potential blockbuster therapy for acute heart failure, serelaxin, calling the study an overall success and making executives of the Swiss drug giant confident in their plans to seek regulatory approvals. Yet analysts have pointed out that there are some challenges ahead for Novartis to fulfill big expectations for the drug.

With physicians clamoring for new options for heart failure patients, Novartis ($NVS) showed that its Phase III study of serelaxin (RXL030) met one of the main goals of reducing shortness of breath at day 5. The trial failed to reach the goals of reducing the symptom at earlier intervals for patients on the therapy, but succeeding with one primary endpoint was enough to deem the study a winner, according to Novartis. And the company was also trumpeting the 37% reduction in deaths among patients treated with its drug at 6 months, saying the therapy is the first to deliver a mortality benefit in heart failure patients.

"While we have good medications at hand which can improve the symptoms and the prognosis of patients with chronic heart failure, there is currently no good treatment if the situation becomes suddenly worse," Dr. Pascal Meier, a cardiologist from Yale School of Medicine, who is unaffiliated with the study, told The Wall Street Journal. "New treatment options for these patients are urgently needed."

Like many of its pharma peers, Novartis has urgent needs of its own. The drugmaker is girding for generic drug competition to major sellers such as its hypertension drug Diovan and its leukemia therapy Gleevec. Serelaxin, which is based on the natural hormone relaxin that helps mothers during pregnancies, has the potential to hit annual sales of $2.5 billion, according to Deutsche Bank analysts, as quoted by Reuters.

Yet Novartis' therapy might need to clear additional hurdles with hospitals that administer the drug even if regulators give it the thumbs-up, and the failed promise of Johnson & Johnson's ($JNJ) Natrecor has left some people skeptical about new heart failure meds.

"At least in the U.S., in-hospital drugs are often scrutinized more heavily because hospital budgets are tight," Bernstein analyst Tim Anderson wrote in a note prior to release of the results, as quoted by the WSJ. "Even with regulatory endorsement, Serelaxin would have to undergo a second round of reviews from those paying for the product."

Novartis is among a herd of companies seeking the spotlight for their cardio therapies during the big American Heart Association (AHA) meeting in Los Angeles this week.

- here's Novartis' release
- see the WSJ article (sub. req.)
- and Reuters' report

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