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UPDATE 1-Actelion gets go-ahead to continue new drug trial
May 8, 2013 / 7:11 AM / 5 years ago

UPDATE 1-Actelion gets go-ahead to continue new drug trial

* Selexipag is new drug for pulmonary arterial hypertension

* Final results due by mid 2014

* Actelion looking for alternatives to main drug Tracleer (Adds details, background)

ZURICH, May 8 (Reuters) - Actelion should continue a late-stage study into a new heart and lung drug, independent monitors have recommended, with final results now expected by mid-2014, giving the biotech firm hope it has a further product in its pipeline.

Actelion said in a statement the Independent Data Monitoring Committee had told the company it had unanimously recommended the continuation of a late-stage study in selexipag with no modifications, adding final results should come next year.

Selexipag is the third drug from Actelion to treat pulmonary arterial hypertension (PAH), a progressively worsening condition characterised by abnormally high blood pressure in the arteries of the lungs. The cause is unknown and the disease has no cure.

The company received a boost last year after Opsumit, another treatment for PAH, beat expectations in a clinical trial, raising hopes the firm has a viable successor to its main product Tracleer, which makes up just under 90 percent of sales.

Actelion noted that an earlier study had already showed selexipag produced a significant reduction in pulmonary vascular resistance, a symptom of PAH.

It said the goal of the interim analysis was to decide whether the study should be continued based on the primary objective of demonstrating the benefits of the drug.

U.S. regulators are set to decide in October whether to approve Opsumit. Actelion has also filed the drug for approval in the European Union.

Actelion has cut costs over the past year and refocused its research spending on its PAH drugs, with its pipeline in immunomodulation and antibiotics a second focus.

Actelion posted stronger-than-expected sales in the first quarter and said it may return to profit growth sooner than expected. (Reporting by Caroline Copley; Editing by David Cowell)

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