Actelion's Uptravi Shows Long-term Benefit in GRIPHON - Analyst Blog

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Actelion Ltd.ALIOF announced the presentation of encouraging long-term data on Uptravi from a double-blind, placebo-controlled, event-driven phase III study, GRIPHON, for the treatment of pulmonary arterial hypertension (PAH) at the American College of Cardiology Congress held at San Diego.

In the GRIPHON study, the patients suffering from PAH were randomized 1:1 to receive either Uptravi or placebo. Patient dosing was initiated at 200 mcg twice daily, which was increased weekly in steps of 200 mcg up to a maximum of 1600 mcg twice daily. Actelion emphasized that in this study Uptravi reduced the risk of a morbidity or mortality event by 40% compared to placebo. The company said that once patients were titrated to the highest tolerated dose, Uptravi's benefit was found consistent across the pre-specified low-, medium- and high-maintenance dose groups.

Additionally, Actelion mentioned that Uptravi also benefited patients, who were already receiving treatment for PAH, including those on combination therapy at baseline. Moreover, Uptravi-treated patients achieved a statistically significant increase in the six-minute walk distance at week 26 (with an improvement of 34 meters in treatment-naïve PAH patients). Overall, Uptravi was well-tolerated in the patients.

Based on this data, Actelion deduced that Uptravi has the potential to proactively treat patients suffering from the disease and may offer long-term outcome benefits, upon approval.

We remind investors that Actelion is in the process of submitting the registration dossier for Uptravi to the regulatory authorities in different countries. In Dec 2014, the company filed for the candidate with the European Medicines Agency for the treatment of patients suffering from PAH. Uptravi is under review in the U.S., New Zealand, Switzerland and Canada.

Our Take

We are encouraged by the long-term data from the GRIPHON study. Although Actelion holds a lead position in the market for PAH treatments with products like Tracleer, Ventavis, Veletri and Opsumit, generic competition and pricing pressure are expected to intensify for Tracleer and Ventavis in 2015. In this scenario, potential approval for a new candidate will be a highly awaited event for investors. Upon approval, it should help the company maintain top-line growth.

Actelion carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP , Cytokinetics, Inc. CYTK and Horizon Pharma plc HZNP . All these stocks carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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