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Actelion to Boost Progress of Specialty Immunology Pipeline - Analyst Blog

Actelion Ltd.ALIOF announced its decision to step up its efforts to develop its pipeline in the field of immunological disorders and provided an outlook into its pipeline development plans. The company's decision is supported by the outcome of a scientific, medical and commercial assessment of a series of selective S1P1 receptor modulators, which have been discovered in-house.

Actelion is currently evaluating its lead S1P1 receptor modulator, ponesimod, for the treatment of patients suffering from relapsing multiple sclerosis and intends to start enrolling patients in a phase III study (OPTIMUM), immediately. The randomized, double-blind, parallel-group, active-controlled, multi-center OPTIMUM study will compare the efficacy and safety of ponesimod to Sanofi's SNY Aubagio in patients suffering from relapsing multiple sclerosis. Approximately 1,100 patients are expected to be enrolled in the study. It is expected to be completed in the 2018-2019 timeframe.

The company said that an extension of the phase II study on ponesimod for multiple sclerosis is ongoing and has already provided a substantial amount of long-term efficacy and safety data.

Meanwhile, Actelion intends to initiate an open-label, single-arm, intra-subject dose-escalation phase II study to evaluate the biological activity, safety, tolerability and pharmacokinetics of ponesimod in patients suffering from symptomatic moderate or severe chronic graft versus host disease, who responded inadequately to first- or second-line therapy. The study is expected to be complete within approximately 18 months from the date of initiation.

Additionally, Actelion intends to advance a selective S1P1 receptor modulator to a multi-center, randomized, double-blind, placebo-controlled, dose-response phase II study. The study will assess the biological activity, safety and tolerability of the company's second S1P1 receptor modulator for the treatment of systemic lupus erythematosus. The study is expected to be completed within approximately 20 months from the date of initiation.

Actelion's efforts on pipeline development are appreciable. Actelion has a strong portfolio in pulmonary arterial hypertension (PAH). Currently, its PAH candidate, Uptravi, is under review in the U.S. with an action from the FDA expected by Dec 2015. The company also filed for Uptravi for PAH in the EU in Dec 2014.

Actelion carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP and Horizon Pharma plc HZNP . Both 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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