Actelion’s Uptravi Approved in the U.S. for PAH Treatment

Actelion Ltd. ALIOF announced that the FDA has approved Uptravi for the treatment of patients with pulmonary arterial hypertension (PAH).

Uptravi is approved in the U.S. for the treatment of PAH (WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

The company expects to launch the product in the U.S. in early Jan 2016.

We note that in 2008, Actelion entered into an exclusive worldwide alliance with Nippon Shinyaku for Uptravi for the treatment of patients with PAH. As per the terms of the agreement, Actelion has rights to globally develop and commercialize the product outside Japan, while both companies will co-develop and co-commercialize the product in Japan. Nippon Shinyaku is eligible to receive milestones based on development and sales. In addition, Nippon Shinyaku will receive royalties on product sales.

However, the PAH market is already crowded with drugs like Adcirca, Revatio, Tyvaso and Veletri among others.

Meanwhile, other companies are also looking to bring their own PAH treatments to market. Arena Pharmaceuticals, Inc. ARNA is currently evaluating it’s PAH treatment candidate, ralinepag, in a phase II study. Ralinepag enjoys Orphan Drug status in the U.S.

Actelion currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector includes Anika Therapeutics Inc. ANIK and Achillion Pharmaceuticals, Inc. ACHN both sporting a Zacks Rank #1 (Strong Buy).

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