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Actelion Drug Meets Main Goal in Late-Stage Patient Study

Actelion Ltd.’s experimental drug against a lung disease met the main goal of a late-stage study, potentially giving the company a pill that may garner annual sales of as much as 2 billion Swiss francs ($2.2 billion).

Actelion plans to apply for regulatory approval as soon as possible for selexipag, a treatment for pulmonary arterial hypertension, a deadly and incurable artery-narrowing disease, the Allschwil, Switzerland-based drugmaker said in a statement. Analysts at Barclays Plc estimate peak sales from the product of about 2 billion francs. Actelion stock rose to a record.

“The data has the potential to transform Actelion,” Sachin Jain, an analyst at Bank of America Merrill Lynch, wrote in a note to investors, adding he may double his forecast for the treatment’s peak annual sales to 1.2 billion francs.

Approval would also give Actelion the most effective and convenient drug in a class of medicines called prostacyclin receptor agonists. Most existing treatments, which include United Therapeutics Corp.’s Remodulin and Actelion’s Veletri, need to be injected or inhaled. It would also ease the Swiss drugmaker’s dependence on existing medications Tracleer, which accounts for 86 percent of sales, and its successor Opsumit.

‘Easier’ Terms

“Doctors want a drug of that mechanism that’s easier to prescribe and easier to use,” Richard Parkes, an analyst at Deutsche Bank AG in London, said by phone before the data was announced. “Selexipag is a truly innovative treatment and there’s not really any debate about that.”

Actelion rose 15 percent to 104.50 francs at the close in Zurich, the highest price since the company’s initial public offering in April 2000. The shares have gained 89 percent in the past 12 months, including reinvested dividends, valuing the drugmaker at 12.6 billion francs. More than 4 million shares traded today, about nine times the three-month daily average.

In the trial among 1,156 people, 39 percent fewer patients died or experienced a worsening of their disease when treated with selexipag than those who got a placebo. Fourteen percent of those in the selexipag group stopped treatment because of side effects, compared with 7 percent of those getting a placebo.

“Selexipag is working, but it’s working much better than I had expected,” Jean-Paul Clozel, Actelion’s chief executive officer and co-founder, said on a conference call today, adding that he had predicted side effects would prompt “many more” patients to end participation than was the case. “It’s going to change the whole paradigm of pulmonary hypertension treatment.”

Illness Rate

Pulmonary arterial hypertension is a rare 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 in the arteries of the lungs. That causes symptoms such as chest pain, dizziness and shortness of breath. The disease affects from one in 100,000 people to one in 1 million people, according to the American Lung Association.

Opsumit, approved last year, is designed as a successor for Tracleer, which starts losing patent protection in November next year. The two drugs compete with Gilead Sciences Inc.’s Letairis, which loses patent protection in 2018, and analysts have debated whether doctors will be under pressure to prescribe generic forms of that drug when they’re available, Parkes said.

Prostacyclins are usually prescribed for patients for whom Tracleer, Opsumit or Letairis are no longer effective.

United Therapeutics won U.S. approval in December for an oral form of Remodulin called Orenitram. Still, the Food and Drug Administration said its benefit to improve exercise capacity is “small.”

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