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
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.
[to top of second column]
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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