Novartis to Seek Heart Drug Approval After Test Ends EarlyEva von Schaper
Novartis AG plans to seek approval of a medicine for chronic heart failure sooner than expected, advancing its effort to build a portfolio of cardiac therapies.
The drugmaker is ending a late-stage clinical trial of an experimental medicine known as LCZ696 early after the results showed patients treated with it lived longer without being hospitalized than a group who got standard treatment, the Basel, Switzerland-based company said in a statement today.
Novartis shares rose the most in more than a year in Zurich trading. The study results offered reassurance about the company’s plan to introduce new cardiac medicines, five days after another experimental heart-failure product suffered a U.S. regulatory setback.
“Stoppage for efficacy is certainly a positive surprise,” Michael Leuchten, an analyst at Barclays Plc in London, said in an e-mail. He estimates the drug has the potential to earn at least $1 billion in peak annual sales.
Novartis gained 3.5 percent to close at 75 Swiss francs, the biggest advance since Jan. 23, 2013.
Last week, a U.S. advisory panel recommended against approving Novartis’s serelaxin, a chemical similar to the hormone relaxin that protects the hearts of pregnant women. The Food and Drug Administration, which often follows the advice of its advisers but doesn’t have to, is scheduled to decide whether to clear the medicine for sale by May 17.
The study of LCZ696, known as Paradigm-HF, followed more than 8,000 patients with a certain type of heart failure who received either the Novartis drug or enalapril, the standard treatment.
“Novartis recognizes the huge global need for treatments that extend and improve the lives of people with heart failure and we believe LCZ696’s unique mechanism of action could be transformative,” Tim Wright, Novartis’s head of drug development, said in the statement.
The company plans to start discussions with regulators about marketing approval and to present the trial results to a medical conference, according to the release.
Novartis had expected the data at the end of this year, according to a transcript of a presentation at a Cowen & Co. conference in March. The company also said at the meeting it expected both LCZ696 and serelaxin to generate more than $5 billion in annual sales if they won regulatory approval.
Heart failure, in which the heart becomes unable to pump enough blood throughout the body, often occurs in the wake of other ailments such as hypertension. More than 20 million people live with the disease in Europe and the U.S., according to Novartis.