Actelion Ltd. announced that it had a meeting with the independent Data Monitoring Committee (DMC) regarding the Opsumit phase III DUAL program for the treatment of patients suffering from digital ulcers associated with systemic sclerosis. The committee has recommended the termination of the phase III DUAL-2 study as it feels a positive primary outcome measure is not likely to emerge from additional data.
Currently there are no more patients receiving treatment in the DUAL-1 study. However, the DUAL-1 study will be continued as planned. Actelion will collect and analyze data from both the studies - DUAL-1 and DUAL-2.
In Oct 2013, the U.S. Food and Drug Administration (FDA) approved Opsumit 10 mg once daily for the treatment of pulmonary arterial hypertension (PAH) WHO Group I to delay disease progression. Actelion also received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for Opsumit. Additionally, Opsumit gained Canadian approval last month. Opsumit is currently under review in countries like Switzerland, Australia, Taiwan, Korea and Mexico. Opsumit is the first drug to have proved its efficacy in delaying disease progression over the long term in PAH patients. However, the PAH market looks extremely competitive with the presence of Adempas, Revatio and Letairis
We note that Opsumit is also being evaluated for the treatment of glioblastoma (phase I).
Actelion carries a Zacks Rank #1 (Strong Buy). Investors may also consider companies like Aeterna Zentaris Inc. (AEZS - Free Report) , Jazz Pharmaceuticals (JAZZ - Free Report) and Questcor Pharmaceuticals Inc. (), all of which carry a comparable Zacks Rank #1.