Acelion has filed a marketing application for Opsumit in Europe as it tries to build on its pulmonary arterial hypertension (PAH) franchise.
Opsumit (macitentan) is a follow-up to the Swiss pharma company’s top-selling product Tracleer (bosentan), which accounts for the bulk of Actelion’s sales but is heading for patent expiry between 2015 and 2017. The new drug was submitted to the US FDA last month.
In the phase III SERAPHIN trial, treatment with macitentan reduced the risk of morbidity and mortality compared to placebo over the course of the three-and-a-half year study.
Combined mortality and morbidity was reduced by 45 per cent for patients on 10mg of the drug once a day and 30 per cent lower for patients receiving a 3mg dose, a level of efficacy which analysts have suggested will make macitentan a strong contender in the marketplace.
Actelion reported revenues of 1.3bn Swiss francs ($1.4bn) in the first nine months of the year. Tracleer contributed 1.13bn francs of the total, down 4 per cent, in the face of increasing competition in the PAH market from the likes of Gilead/GlaxoSmithKline’s Letairis (ambrisentan), as well as price cuts.
The company has two other PAH drugs – Ventavis (iloprost) and Veletri (epoprostenol) – which brought in 85m and 18m francs, respectively in the same period.
In addition to macitentan, Actelion is also looking to bolster its PAH franchise with selexipag, which is in phase III testing, as well as a new formulation of Veletri which could reach the market in 2013. The aim is to be able to offer a range of therapeutic options for PAH depending on the functional class of the patient.
Macitentan is the jewel in Actelion’s R&D crown, however, and has been the main reason cited by the company’s chief executive Jean-Paul Clozel for remaining independent in the last couple of years, during which time both Amgen and a private equity operation are rumoured to have been circling the firm.
Earlier this year Actelion reduced its workforce and refocused its research operations to free up the resources it needs to expand in the PAH sector.