Here comes the First-ever Combination Therapy for Multiple Sclerosis

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Actelion is overcoming the upcoming expiration of one of its most profitable patents and it’s using its strong position to make the leap into the crowded market of multiple sclerosis with the first-ever combination therapy.

Actelion is one of the top billion-euro Biotechs in Europe and a leader in pulmonary arterial hypertension (PAH). Although the patent for its lead product Tracleer (bosentan) expires soon, the company is optimistic. In an interview with Bloomberg, Actelion’s CEO Jean-Paul Clozel commented that the company has two aces up its sleeve: Opsumit (macitentan) and Uptravi (selexipag).

Clozel is not trying to hide that he expects a steep decrease in sales when generics appear in the US at the beginning of 2017 and in Europe at the end of next year. However, the company is replacing its leading product with two alternatives that are already outperforming all expectations. Opsumit sales have already surpassed Tracleer with €550M (CHF 596M) and Uptravi has made €148M (CHF 160M) in only 9 months after its launch.

The new drugs Opsumit and Uptravi are small molecules that target vasoconstrictor receptors for endothelin-1 and prostacyclin, respectively. They are quickly attracting new patients and physicians are sending positive feedback.

Actelion PAH drugs
Figure 1. Actelion’s strong portfolio of PAH drugs

The new products’ patents will give Actelion 10 years of financial security in the PAH market. And with these excellent results, the company has decided to make a step forward and expand into Multiple Sclerosis (MS).

This move is risky because there are already plenty of companies targeting MS, with leaders like Novartis, Sanofi, Biogen, Teva and Pfizer crowding the field. Actelion is trying to gain an advantage by targeting the 1 out of 5 MS patients that suffer a relapse every year. Its strategy is the first to use drug combinations in MS – an approach that has already proved effective in diabetes, cancer and heart failure.

Actelion announced in September the start of Phase III trials testing the oral combination of Ponesimod and Tecfidera in relapsing MS (RMS). The MS market is expected to reach €18B ($20B), will this new approach grant the company access to such a competitive market? If so, Actelion will be on track to be the first European-born Biopharma to make it to the Major League.

Featured image: Avarand/
Figure 1 courtesy of Actelion

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