Reuters: Regulatory News: Actelion hits 6-yr high after favourable FDA approval for drug

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Actelion hits 6-yr high after favourable FDA approval for drug Oct 21st 2013, 08:50 Share this Email Print Reprints ZURICH | Mon Oct 21, 2013 4:50am EDT ZURICH Oct 21 (Reuters) - 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 favourable 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 hospitalisation 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 characterised 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. Link this Share this Digg this Email Reprints

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