Good news flowed in at Actelion Ltd. with the Therapeutic Goods Administration of Australia approving Opsumit 10 mg for the treatment of pulmonary arterial hypertension (PAH).
We note that Opsumit was approved by the U.S. Food and Drug Administration on Oct 18, 2013. Health Canada and EU also approved this drug in Nov 2013 and Dec 2013 respectively.
Opsumit is indicated for the treatment of idiopathic and heritable PAH as well as PAH associated with connective tissue disease and congenital heart disease. Opsumit is used to treat patients with WHO Functional class II, III or IV symptoms.
Actelion believes that Opsumit can improve long-term clinical outcomes both in treatment naive patients and those on a combination therapy.
The approval was based on data from the SERAPHIN study. Results from the SERAPHIN study showed that the risk of a morbidity/mortality event was cut by 45% in patients who were administered Opsumit compared to those on placebo.
Actelion is also evaluating Opsumit for additional indications. Opsumit is being evaluated for the treatment of glioblastoma (phase I). It is also being evaluated in a pivotal phase III DUAL program in patients suffering from digital ulcers associated with systemic sclerosis. The independent Data Monitoring Committee (DMC) has recommended the termination of the phase III DUAL-2 study as it feels a positive primary outcome measure is not likely to result from additional data. However, the DUAL-1 study will continue as planned.
In Australia, Opsumit is the first and only PAH drug to have proved its long-term efficacy in PAH patients. The approval of this drug has strengthened Actelion’s cardiovascular portfolio.
Interesting candidates in Actelion’s pipeline include selexipag (PAH) and Cadazolid (clostridium difficile associated diarrhea). Both candidates are undergoing phase III studies. The final results from the study on selexipag are expected in mid 2014.
Actelion carries a Zacks Rank #1 (Strong Buy). Investors may also consider companies like Lannett Company, Inc. (LCI - Free Report) , Endocyte Inc. (ECYT - Free Report) and Forest Laboratories Inc. , all of which carry a comparable Zacks Rank #1.