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Actelion gets US green light for new PAH drug Opsumit

Approval will help reduce impact of generic competition for Tracleer

Actelion HQ Switzerland 

Swiss pharma company Actelion bolstered its pulmonary arterial hypertension (PAH) portfolio after the US Food and Drug Administration (FDA) approved its new oral drug candidate Opsumit.

Opsumit (macitentan) is an endothelin receptor antagonist in the same class as Actelion's big-selling Tracleer (bosentan) but with a lower tendency to cause liver side effects that removes the need for patient monitoring.  It should be launched onto the market in November 2013, according to Actelion.

In trials, Opsumit was effective in delaying progression of PAH, a form of high blood pressure that occurs in the arteries that connect the heart to the lungs. It causes the heart to work harder than normal, which can lead to decreased exercise ability and shortness of breath.

Opsumit was shown to slow down the decline in exercise ability, and prevent worsening symptoms as well as the need for additional PAH medication.

The importance of Opsumit to Actelion cannot be overstated, now that Tracleer is approaching the end of its patent life (with generic competition due to start between 2015 and 2017). Tracleer sales were 1.14bn Swiss francs ($1.26bn) in the first nine months of the year - up 3 per cent - out of total product sales of 1.32bn Swiss francs.

Tracleer is facing increasing competition from new entrants in the PAH market, including Gilead/GlaxoSmithKline's Letairis (ambrisentan) - an endothelin receptor blocker which also requires no liver monitoring - as well as Bayer's first-in-class drug candidate Adempas (riociguat), which was cleared by the FDA earlier this month.

Analysts at Jefferies have suggested Opsumit could bring in peak sales of $1.4bn, which would go a long way towards maintaining the company's growth after Tracleer succumbs to generic competition.

Actelion has two other drugs in its PAH franchise - Ventavis (iloprost) and Veletri (epoprostenol) - but these are much smaller products with collective sales of just over 108m Swiss francs year-to-date. The company is also looking to extend its PAH franchise with selexipag, which is in phase III testing.

"Over the past few months, Actelion has prepared the organisation for a successful global market introduction of macitentan," said the company in its third-quarter results statement. The drug is also filed in the EU with approval expected in early 2014.

Article by
Phil Taylor

21st October 2013

From: Sales

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