Actelion Submits Marketing Application for Uptravi in EU - Analyst Blog

Actelion Ltd. (ALIOF) announced that it has submitted a centralized marketing authorization application to the European Medicines Agency (EMA) for its pulmonary arterial hypertension (PAH) candidate, Uptravi (selexipag).

Actelion is one of the key players in the PAH market and has 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. Hence, we believe that the filing for Uptravi is an important step for Actelion. If approved, Uptravi will further strengthen Actelion's PAH portfolio and boost the top-line.

Actelion is developing Uptravi under collaboration with Nippon Shinyaku.

We note that the market for PAH is already crowded. Some drugs approved for this indication are 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 has Qualified Infectious Disease Product (QIDP) designation in the U.S. along with fast track status.

Besides developing its proprietary specialty franchises, Actelion is also on the lookout for innovative assets from external sources.

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 biotech sector is Biogen Idec, Inc. (BIIB) carrying a Zacks Rank #1 (Strong Buy).