Actelion Submits New Drug Application for Uptravi in the U.S. - Analyst Blog

Actelion Ltd. (ALIOF) announced the submission of a new drug application to the FDA for its pulmonary arterial hypertension (PAH) candidate, Uptravi (selexipag).

According to the American Lung Association, PAH is a relatively rare disease that affects 1 person in 100,000 to 1 person in 1 million with approximately 50% of the patients dying within five years of diagnosis.

Actelion is one of the key players in the PAH market with four products in the PAH franchise – Opsumit, Tracleer, Ventavis and Veletri. While Tracleer is one of the important contributors to Actelion's revenues, it is currently facing generic competition in several ex-U.S. markets and is expected to lose patent protection in 2017.

We believe that the filing for Uptravi in the U.S. and the EU is an important step for Actelion. Upon approval, Uptravi will further strengthen Actelion's PAH portfolio and boost the topline. Actelion also submitted a centralized marketing authorization application to the EMA for Uptravi for the same indication in Dec 2014. The application is now pending validation.

We note that the market for PAH is pretty crowded. Some drugs approved for the treatment of PAH include United Therapeutics' (UTHR) Remodulin, Orenitram and Tyvaso, and Bayer's (BAYRY) Adempas.

Meanwhile, Actelion is working towards building additional specialty franchises beyond PAH. Cadazolid is in a phase III study for the treatment of clostridium difficile-associated diarrhea. Results should be out in 2016. Cadazolid enjoys Qualified Infectious Disease Product designation in the U.S. along with fast track status.

We expect investor focus to remain on regulatory updates from the company.

Actelion carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharmaceutical sector is ANI Pharmaceuticals, Inc. (ANIP), carrying a Zacks Rank #1 (Strong Buy).

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