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Approval of Actelion Ltd's Tracleer for use in a fatal lung disease could double sales of its biggest drug, the biotech company's chief executive told Reuters. Actelion, fresh from signing the largest-ever biotech-pharma licensing deal with GlaxoSmithKline Plc, has discussed the design of a late-stage trial of Tracleer in idiopathic pulmonary fibrosis (IPF) with US regulators and expects results late in 2009, Jean-Paul Clozel said.
"If this IPF trial is positive, I am very hopeful that this new indication for Tracleer will be approved," Clozel, a French cardiologist who helped found the company in 1997, said in an interview at Actelion's Basel headquarters.
"This means doubling Tracleer sales." Actelion has been trying to reduce its dependence on Tracleer - which faces growing competition in its primary use in pulmonary arterial hypertension (PAH), a rare heart and lung condition - by developing it in other indications and bringing new drugs to market.
Tracleer rakes in more than $1 billion a year but faces growing competition from drugs such as Gilead Sciences Inc's Letaris and Thelin from Pfizer Inc Switzerland's largest biotech company still sees room for Tracleer to grow in PAH, but would not expect the same rapid acceleration, Clozel said.
"They (rivals) will have a share of the market but I am convinced that we will remain for a long time the leader, hopefully for ever," said Clozel. "I don't think there is any major advantage of any of our competitors."
Actelion has grown rapidly since listing on the Swiss stock exchange in 2000 and, with a current market capitalisation of $7 billion, will join the Swiss blue chip SMI index next month. Glaxo said last month it could pay Actelion up to $3.3 billion to develop a promising insomnia drug called almorexant, beating many of the world's biggest drugmakers to the deal.
Markets have often speculated that Actelion could be a take-over candidate for a big drugmaker, but Clozel said it aimed to remain independent and welcomed the structure of the Glaxo agreement, which gives the Swiss company a share of profits from almorexant and leadership of the development programme.

Copyright Reuters, 2008

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