) had a very successful 2013 driven by the approval of Opsumit in
the U.S. and EU in Oct 2013 and Dec 2013 respectively.
Tracleer (pulmonary arterial hypertension (PAH)), the
significant revenue contributor, loses patent protection in the
2015-2017 timeframe. With an objective to replace the lost
revenues from Tracleer once generics available, the company
decided to develop Opsumit and selexipag. Selexipag is undergoing
phase III development.
Opsumit 10 mg once daily is approved for the treatment of
PAH WHO Group I to delay disease progression. Opsumit is
available in the U.S. since Nov 2013 and its first EU launch is
planned for Germany in Feb 2014. Actelion will launch Opsumit in
Canada in early 2014.
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 reduced by 45% in patients who were
administered Opsumit compared to those on placebo. The study also
showed a reduction in the risk of PAH related hospitalization and
death by 50%.
We believe the launch of Opsumit in the U.S. will strengthen
Actelion's cardiovascular portfolio. Opsumit is the first drug to
have proved its efficacy for delaying disease progression over
the long term in PAH patients.
Actelion saw another product approval from the U.S. Food and
Drug Administration (FDA) this year. Valchlor was approved in the
U.S. in Aug 2013 for the treatment of patients with stage IA and
IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).
The drug has been approved for treating patients who have
previously undergone skin-directed treatment. It is available in
the U.S. since Nov 2013.
With the launch of new products, we expect the company to
perform well in 2014. Actelion currently carries a Zacks Rank #3
(Hold). Investors may consider companies like
Lannett Co., Inc.
WuXi PharmaTech (Cayman) Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).
ACTELION LTD (ALIOF): Get Free Report
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