Actelion hits six-year high after favorable FDA approval for drug

Shares in Swiss group Actelion climbed more than five percent to their highest since late 2007 on Monday on optimism it has a viable product to secure sales and profit after U.S. approval for a new heart and lung drug with a favorable label.

The Food and Drug Administration approved the Swiss biotech company’s pulmonary arterial hypertension (PAH) drug Opsumit late on Friday and, notably, did not impose a black box warning requiring ongoing mandatory liver testing.

This gives the medicine an advantage over Actelion’s older product and current main seller, Tracleer, which had sales of 1.5 billion Swiss francs ($1.66 billion) in 2012 but loses patent protection from 2015.

“Opsumit’s FDA approved label is close to a best case outcome, in our view,” said Deutsche Bank analyst Richard Parkes, who has a ‘buy’ rating on the stock and raised his price target to 72 francs from 70 francs.

Shares in Actelion were up 5.3 percent at 68.00 francs by 0752 GMT, outperforming a 0.5 percent firmer European healthcare sector index.

Analysts at Jefferies agreed and said the drug had the “unique indications” of delaying disease progression and reducing hospitalization due to PAH.

The brokerage, which forecasts peak sales of $1.4 billion assuming a 40 percent new PAH patient share at a 15 percent price discount to Tracleer and Gilead Sciences’ rival drug Letairis, also raised its price target to 79 francs from 71 francs.

Analysts at Berenberg were more cautious and said the requirement for doctors to carry out pre-therapy liver testing before prescribing Opsumit was slightly more burdensome than what is required for Letairis.

Pulmonary arterial hypertension, or PAH, is characterized by High Blood Pressure in the arteries connecting the heart to the lungs, which causes the right side of the heart to work harder than normal and leads to shortness of breath.

Opsumit belongs to a class of drugs known as endothelin receptor antagonists, which relax the pulmonary arteries and decrease that pressure.

($1 = 0.9017 Swiss francs)

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(Reporting by Caroline Copley, Editing by Patrick Lannin)

(Reuters)