New data backs wider use of flagship Actelion drug
VIENNA, Sept 2 (Reuters) - Actelion's ATLN.S top-selling drug Tracleer can help less sick patients with pulmonary arterial hypertension (PAH), as well as those with advanced disease, researchers said on Sunday.
The news could unlock a wider market for the treatment by encouraging doctors to screen for patients who might benefit from earlier therapy.
Nazzareno Galie, a cardiologist at the University of Bologna in Italy, said the drug, known generically as bosentan, helped stabilise the condition of patients with Class II PAH and also improved blood flow.
Tracleer is currently only approved for treating patients with Class III or IV PAH, a rare but life-threatening form of hypertension.
In a study involving 185 patients treated for six months, only 3 percent of patients on Tracleer saw their condition worsen significantly against 14 percent on placebo -- a 77 percent relative risk reduction.
The treated group also had a 23 percent improvement in pulmonary vascular resistance, which measures the resistance to blood flow in the lungs.
Raised resistance to blood flow in the lungs is a hallmark of PAH and leads to an extra load on the heart, which ultimately causes heart failure.
Adverse events were comparable in both arms of the trial, although there was an increase in liver enzymes in patients on Tracleer, as seen in previous clinical trials. Patients taking Tracleer and other similar drugs need routine liver tests.
Craig Hopkinson, Vice President of U.S. Medical for Actelion, said the study findings were a boost for the product and the company hoped that regulators would approve its earlier use by the second half of 2008.
"It is a significant step forward," he told Reuters.
"Most patients only get caught when they have progressed to Class III. As we start screening and detecting patients earlier on and placing patients on treatment earlier on, then essentially we will be diagnosing in functional Class II."
Landsbanki Kepler analyst Denise Anderson said in a note before the data was released that good results could significantly boost the pool of diagnosed PAH patients, further helping the Tracleer franchise, which had sales of 899 million Swiss francs ($746 million) last year.
((editing by Greg Mahlich; e-mail: ben.hirschler@reuters.com; Reuters Messaging: ben.hirschler.reuters.com@reuters.net; +44 7771 575 829))
($1=1.205 Swiss Franc) Keywords: CARDIOLOGY ACTELION/
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