Actelion Ltd. (ATLN) fell in Zurich trading after JPMorgan Chase & Co. said the stock already reflects clinical trial data showing that the company’s experimental macitentan drug helps patients with a fatal lung disease.
Actelion dropped as much as 2.3 percent and was trading 1.1 percent lower at 44.83 Swiss francs at 10:30 a.m. at 50 percent above the three-month average volume. The stock had risen 42 percent this year. JPMorgan cut the stock to neutral from overweight, James Gordon, a London-based analyst, said in a report today. He lowered his price target to 49 francs from 53 francs.
The study presented yesterday supports the view the drug will be approved for sale by regulators, and that it’s different from existing treatments, he said. People with pulmonary arterial hypertension who took macitentan at its highest 10- milligram dose showed an improvement of 23 meters (75.5 feet) in a six-minute walk test compared with a placebo in the study dubbed Seraphin, Allschwil, Switzerland-based Actelion said in a statement.
The drug is key to the company’s future. Chief Executive Officer Jean-Paul Clozel cited macitentan’s potential as a reason for the company to remain independent when he fought off a hedge fund seeking board seats and wanted Actelion to consider selling itself. Tracleer, Actelion’s existing pill for the illness, accounts for 87 percent of company sales and starts losing patent protection in 2016.
“We see a high chance of macitentan approval and reimbursement,” Gordon wrote. “However, with U.S. priority review uncertain, we may not see approval until late 2013.” It’s also unclear whether the drug’s label will carry a warning for liver toxicity, and the challenges of getting European governments to pay for the drug remain, he said.
The research was presented at a meeting of the American College of Chest Physicians in Atlanta. Macitentan provides “a strong and sustained benefit to patients suffering” from the disease, the company said in the statement.
Pulmonary arterial hypertension is a deadly disease in which the arteries that carry blood from the heart to the lungs narrow, making the heart work harder and causing elevated blood pressure. That causes symptoms such as chest pain, dizziness and shortness of breath. There’s no cure.
Bayer AG (BAYN)’s experimental drug riociguat helped patients walk an additional 36 meters in the six-minute walk test, the Leverkusen, Germany-based company said Oct. 22.
Macitentan’s 23-meter benefit was “potentially at the lower end of what some investors may have been hoping for,” JPMorgan’s Gordon wrote.
Actelion said in April that macitentan lowered the risk of the disease worsening by 45 percent in the trial, without giving details. The drug also reduced the risk of death by 36 percent, but the result fell short of the statistical threshold at which the company can say it wasn’t the result of chance.
A summary of the study, published last week in advance of the conference, showed the drug halved the risk of death or hospitalization. A 10-milligram dose also cut the risk of the disease worsening by 38 percent in patients getting another treatment, and 55 percent in those receiving nothing else.
Actelion has submitted macitentan for regulatory approval in the U.S. and plans to sell it under the brand name Opsumit, the company said in a statement Oct. 22.
Tracleer’s sales fell in the first nine months of the year on competition from Gilead Sciences Inc.’s (GILD) Letairis in the U.S. and on price cuts.
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