Actelion gets EU nod for Tracleer follow-up

Switzerland’s Actelion won approval for its new pulmonary arterial hypertension (PAH) therapy Opsumit in the EU, a few weeks after getting a green light in for the drug in the US.

Now Opsumit (macitentan) is registered on both sides of the Atlantic Actelion can press on with building market share for the drug, which is positioned as a next-generation successor to its big-selling PAH therapy Tracleer (bosentan).

Tracleer achieved turnover of around $1.3bn in the first nine months of this year and accounts for the bulk of Actelion’s revenues, but is due to start losing patent protect in 2015.

Opsumit – which like its predecessor is an endothelin receptor antagonist (ERA) and was launched in the US last month – is less likely to cause liver side effects than Tracleer so does not have labelling requiring patient monitoring.

The absence of a liver monitoring requirement has already helped Gilead Sciences/GlaxoSmithKline’ rival ERA Letairis (ambrisentan) make headway in the marketplace, and in general the PAH market is looking increasingly competitive with the recent approval of new agents such as Bayer’s first-in-class drug candidate Adempas (riociguat).

Actelion is banking on the strength of Opsumit’s clinical data set helping it build rapid share in the market.

The drug was tested in the largest trial ever conducted in PAH – the SERAPHIN study – and demonstrated benefit in reducing mortality and morbidity over the long-term.

Analysts have suggested this profile could help Opsumit reach $1.4bn or more in sales, which would go a long way towards replacing revenues lost when Tracleer succumbs to generic competition.

Meanwhile, Actelion is also hoping to extend its PAH franchise still further with selexipag, an IP receptor agonist in phase III testing. Results from the main GRIPHON trial are due to report in the middle of 2014.

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