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Actelion’s Key Drug Halves Risk of Death, Hospitalization

Actelion ‘Day of Reckoning’ for Macitentan Overshadows Earnings
Investors will be looking for evidence that Actelion’s experimental lung drug, macitentan, can replace Tracleer, the pill that accounts for 87 percent of the company’s sales and starts losing patent protection in 2016. Source: Actelion Pharmaceuticals Ltd/copyright 2011 via Bloomberg

Actelion Ltd.’s experimental lung drug macitentan halved the risk of death or hospitalization from pulmonary arterial hypertension in a preview of a study to be presented next week that is key to Actelion’s future.

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, according to a summary of the trial published on the website of the journal CHEST. Actelion said in April macitentan lowered the risk of the disease worsening by 45 percent, without giving details.

Investors have been anticipating the data because they’re looking for evidence that macitentan can replace Tracleer, the pill that accounts for 87 percent of Actelion’s sales and starts losing patent protection in 2016. Actelion plans to submit macitentan for regulatory approval in the U.S. and Europe in the coming weeks, and will sell it under the brand name Opsumit, the company said in a statement today.

The reduction in deaths and hospitalizations due to PAH was “impressive,” Peter Welford, an analyst at Jefferies International Ltd. in London, said in a telephone interview. “Given that PAH hospitalization is a hard endpoint, and one I think payers will respond to, to reduce that by 50 percent with the 10-milligram dose I would say is very promising.”

Staying Independent

For Actelion, macitentan is more than just another product in development. Amgen Inc. in 2010 considered making a takeover offer for the Allschwil, Switzerland-based company, and Chief Executive Officer Jean-Paul Clozel cited the drug’s sales potential as a reason for Actelion to stay independent. He reiterated that position last year in fighting off a hedge fund that sought seats on the board and wanted Actelion to consider selling itself.

Actelion rose 0.6 percent to 46.83 Swiss francs in Zurich, giving the company a market value of 5.9 billion francs ($6.4 billion). The stock has advanced 48 percent this year, including reinvested dividends, compared with an 18 percent return in the Bloomberg Europe Pharmaceutical Index.

Roland Haefeli, an Actelion spokesman, said the company can’t comment on the study, known as Seraphin, before it’s presented Oct. 23 at a meeting of the American College of Chest Physicians in Atlanta.

No Cure

Third-quarter net income rose 16 percent to 94.6 million Swiss francs, Actelion said today. The company benefited from the weakening of the franc against the dollar and Japanese yen, and as it cut costs to compensate for a decline in Tracleer revenue. Sales of the drug fell in the first nine months of year on competition from Gilead Sciences Inc.’s Letairis in the U.S. and on price cuts.

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.

Other key data that doctors, investors and analysts are expecting wasn’t included in today’s abstract, including the results of a test showing whether macitentan can increase the distance patients can walk in six minutes, a measure used in most other trials of drugs for PAH that will enable comparisons between treatments.

Walk Distance

“For the last 15 years we’ve really been focused on six-minute walk distance,” Hunter Champion, an associate professor of medicine at the University of Pittsburgh, said before the summary was published. “If we’re trying to examine efficacy, that’s really the one benchmark that you have available that you could use against every therapy.”

An improvement of at least 30 meters (98.4 feet) would be a significant benefit, said Rachel Davies, a doctor who treats PAH patients at Hammersmith Hospital in London. The improvement may only be as much as 10 to 15 meters, Richard Parkes, an analyst at Deutsche Bank AG in London, wrote in an Oct. 15 note.

A more telling statistic, and one that also wasn’t published in today’s abstract, may be whether macitentan prolongs life, Parkes wrote. The company said in April that while macitentan showed a trend toward delaying death, the result fell short of the statistical threshold at which the company can say it wasn’t the result of chance.

Doctors, investors and analysts will be keen to see just how large the trend is, and how far short of the threshold it fell. If the data indicate that 20 percent or more of patients’ lives were extended, and if the statistical miss is narrow, doctors may be impressed, Parkes said.

Statistical Significance

“The big thing is going to be how close to statistical significance it is,” said Champion, who consults for Gilead and has done work for Actelion in the past. “I’m not going to completely shut down the idea that macitentan is a good drug if it’s the same as Letairis and Tracleer on six-minute walk, if other aspects of it have an advantage.”

Davies disagrees.

“I’m a bit of a puritan when it comes to statistics,” she said. “I would not take a message home that this is an improvement in mortality.”

Doctors already know that macitentan will have certain advantages over Tracleer. Like Gilead’s Letairis, it’s a once-daily pill, whereas Tracleer is twice-daily. Preliminary data presented in April also suggested patients on macitentan may have fewer liver side effects than those on Tracleer, who are required to have a monthly liver test.

Head to Head

Still, because the trial compared macitentan with a placebo, instead of Tracleer or Letairis, the two best-selling treatments for the disease, the data won’t prove whether macitentan is better than those medicines.

“The only way we can ever truly know whether or not the drug is superior to other drugs is when they go head to head,” Hammersmith’s Davies said. “If there is no head-to-head data, then they can try and lead clinicians down the line to say that we have these pseudo-markers that macitentan is better than Tracleer.”

Chief Financial Officer Andrew Oakley said in June that a head-to-head trial would have had to involve more than 5,000 patients, which “is just not doable.”

Actelion today repeated its sales and profit forecasts for this year, as well as its earnings-growth forecasts for 2013-2015.

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