With FDA nod, Actelion adds blockbuster hopeful Uptravi to PAH portfolio

Actelion has been laboring to fill the void left by declining sales of aged pulmonary arterial hypertension (PAH) med Tracleer. And now, it has another tool to work with.

The Swiss biotech won FDA approval for Uptravi, a blockbuster hopeful green-lighted to delay disease progression and cut the risk of hospitalization for patients with PAH. The company expects to bring its newcomer to U.S. patients in early 2016, it said.

Uptravi will join baseline therapy Opsumit and late-stage treatment Veletri in Actelion's portfolio, giving Actelion a bridge between the two--and the chance to beef up sales as Tracleer generics take their toll.

Actelion CEO Jean-Paul Clozel

"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 thanks to Opsumit, Actelion hasn't been ailing as sales of Tracleer slipped. In the third quarter, the older treatment declined by CHF 60 million to CHF 289 million, a 17% drop--but Opsumit was rolling, jumping from CHF 58 million to CHF 147 million to plug the gap and then some.

That momentum for Actelion's new launch was enough to prompt Clozel to declare that his company doesn't "need" M&A, though in the past its name has been in the conversation as both a buyer and a target. In September, it bid unsuccessfully for ZS Pharma, which ultimately went to AstraZeneca ($AZN). And rumors of Shire's ($SHPG) courtship surfaced in June, though the Dublin drugmaker is currently working hard to ink a pact for Illinois' Baxalta ($BXLT).

Meanwhile, with Uptravi in the PAH mix, Bayer will have to look out. The German drugmaker counts its own PAH contender, Adempas, among 5 growth products it expects to anchor its pharma unit for years to come.

- read Actelion's release

Special Report: Top 10 Cardio Drugs 2012 - Tracleer

Read more on