March 31, 2014 / 6:55 AM / 5 years ago

Novartis closes heart drug study early after strong results

ZURICH (Reuters) - Novartis has ended a late-stage clinical trial of a chronic heart failure drug early, following strong interim results, giving the Swiss drugmaker a boost after recent setbacks to another heart failure medicine.

A Novartis logo is pictured on its headquarters building in Mumbai February 6, 2014. REUTERS/Danish Siddiqui

The Basel-based firm said on Monday an independent committee had unanimously recommended it close its PARADIGM-HF study ahead of time after results showed patients receiving its LCZ696 drug lived longer without being hospitalized for heart failure than those who were given enalapril, the standard care.

The Swiss drugmaker, long a major player in cardiovascular medicine, is looking to LCZ696 as one of two new treatments for heart failure that could revive its fortunes as top-selling blood pressure pill Diovan faces generic competition.

Novartis said it would present the full data at an upcoming conference and seek approval for the drug from global regulators.

“If full results are robust, LCZ696 could represent another blockbuster drug in the category of cardiovascular medicine that the company knows well,” Bernstein analyst Tim Anderson said, adding he was aware of no near-term competitors for the drug.

Citi analyst Andrew Baum said the drug could have the potential to achieve peak annual sales of more than $5 billion and could become the first new medicine to be approved for chronic heart failure in over a decade.

At 0840 GMT, shares in Novartis were up 1.9 percent at 74.35 Swiss francs, outperforming a 0.5 percent firmer European healthcare sector index.

The positive news for LCZ696 contrasts with recent setbacks for Novartis’ other acute heart failure drug, Serelaxin.

Last week, a panel of advisers to the U.S. Food and Drug Administration recommended Serelaxin not be approved because of insufficient evidence it improves symptoms, echoing a recommendation by European regulators which also ruled against the drug.

Heart failure is a condition where the heart struggles to pump blood around the body. Unlike a heart attack, in which a heart artery becomes blocked, it develops progressively.

More than 20 million people suffer from heart failure in Europe and the United States alone, Novartis said.

LCZ696, a twice a day pill, is a combination of Diovan, or valsartan, and another class of drug called a neprilysin inhibitor.

The study was evaluating LCZ696 in patients with so-called reduced ejection fraction chronic heart failure.

($1 = 0.8870 Swiss Francs)

Editing by Mark Potter

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