Actelion wins FDA approval for a next-gen hypertension drug

Actelion CEO Jean-Paul Clozel

Swiss biotech Actelion extended its lead in the pulmonary arterial hypertension market, picking up FDA approval for a follow-on treatment that should help ward off mounting competition in the space.

The drug, selexipag, is an oral therapy designed to improve long-term outcomes for patients with PAH, a narrowing of blood vessels in the lungs that can lead to heart failure. Approved as Uptravi, the drug demonstrated a marked effect on delaying cardiac events in a four-year Phase III trial on more than 1,000 patients, and it is now indicated as a disease-delaying therapy for patients whose PAH has not yet advanced.

The approval is key for Actelion's ($ATLN) foundational franchise of PAH treatments. The company's Opsumit, an oral treatment approved in 2013, is indicated as a starter therapy for newly diagnosed PAH, while Veletri, an intravenous therapy launched in 2010, is cleared for patients with late-stage disease that isn't responding to standard therapy. Uptravi, once on the market next year, gives Actelion a bridge therapy that could blossom into a blockbuster product.

"Actelion now has an unparalleled portfolio of treatments across the continuum of care in PAH that offer a combination of long term-efficacy, safety and convenience," CEO Jean-Paul Clozel said in a statement.

And the launch of Uptravi should help Actelion defend its market position now that new PAH drugs from United Therapeutics ($UTHR) and Bayer have entered the picture. And Tracleer, Actelion's first PAH blockbuster, lost patent protection earlier this year, clearing the way for cheap generics to further complicate the market.

Meanwhile, Actelion has remained a frequent figure in M&A rumors, whether as buyer or seller. Months of speculation that Shire ($SHPG) might make an offer for the company have largely cooled, but Actelion's own failed bid for ZS Pharma ($ZSPH)--which now is set to become part of AstraZeneca ($AZN)--sparked speculation that the PAH magnate might be shopping on its own. In October, Actelion Chief Financial Officer André Muller said that while M&A is "not a fundamental aspect of our strategy," his company has had regular discussions with between 7 and 8 potential targets.

- read the statement

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