Actelion Ltd.’s experimental drug macitentan has a “very high” probability of success in a clinical trial that will be critical for the company’s future, Chief Executive Officer Jean-Paul Clozel said.
Data from a late-stage trial of the medicine, a successor to Actelion’s top-selling lung drug Tracleer, will “realistically” be released in the second quarter, Clozel said in an interview yesterday in San Francisco.
“What is important for us is to do everything in order for the trial to succeed,” such as monitoring the quality of data collection, Clozel said. “We are working on making this thing work.”
Actelion, based in Allschwil, Switzerland, needs macitentan to help bolster earnings after Tracleer begins to lose patent protection and faces competition from cheaper generic drugs in 2015. Efforts to reduce reliance on the lung therapy, which last year accounted for almost 90 percent of sales, faltered over the past months after several clinical trial setbacks.
Clozel juggled in 2011 with shareholder unrest and speculation that the company may be taken over. Elliott Advisors (UK) Ltd., which pushed for a sale of Actelion, failed in May to oust the CEO from the board and to replace other directors. The hedge fund has since cut its stake to less than 3 percent, according to a Sept. 28 stock exchange filing.
Tracleer, which generated 1.64 billion Swiss francs ($1.57 billion) in sales in 2010, has dominated the market for pulmonary arterial hypertension since it was approved in 2001. The condition causes high blood pressure in the artery that moves blood from the heart to the lungs and can be fatal.
Management is working to prepare Actelion for the aftermath of the macitentan trial results, Clozel said during an interview at the J.P. Morgan Healthcare Conference in San Francisco.
“There are big chances that macitentan works so we are trying to prepare its future launch,” he said. Should the experimental drug fail, the company’s board would be forced to consider “all options,” he added, declining to elaborate.
“It’s our job to say ‘What happens if it doesn’t work?,’” Clozel said. “We have to be ready. We are preparing some plan B. This is my job and the board’s job. All the options will have to be evaluated.”
Clozel, a former scientist with Roche Holding AG, founded Actelion in 1997 with his wife Martine and three other executives to develop medicines that had been abandoned by Roche.
Shares in the company fell the most in more than three weeks yesterday to 32.60 Swiss francs after Actelion said in a statement that it missed its 2011 profit-growth target because of a charge for late payments from southern European health-care providers.
The charge, of as much as 35 million euros ($45 million), is a “fair estimate” of amounts Actelion is owed by public hospitals and other institutions mainly in Spain, Italy, Portugal and Greece, Clozel said during the interview.
“We are well paid in many of these countries, but some hospitals, some places, for example some provinces in Spain, just don’t pay as well as they should pay,” he said. “The general managers are trying to get paid, we are in discussions with all these hospitals.”
Actelion is still supplying these countries with treatments, Clozel said.
The Swiss drugmaker is “always” pursuing opportunities to acquire other companies or license products, Clozel also said.