) recently announced that it has initiated a phase III study to
evaluate the use of Benlysta (belimumab) in patients suffering
from anti-neutrophil cytoplasmic antibodies (ANCA) positive
The multi-centre, randomized, double-blind phase III study will
assess the efficacy and safety profile of Benlysta in combination
with azathioprine as a maintenance therapy in ANCA positive
We note that ANCA positive vasculitis, which is characterized by
inflammation of the blood vessels, can be further categorized
into granulomatosis with polyangiitis (Wegener's) and microscopic
We note that Benlysta is already available for treating patients
suffering from systemic lupus erythematosus. Benlysta was
approved by the US Food and Drug Administration (FDA) and
European Commission (EC) for the indication in 2011. In the
fourth quarter of 2012, Benlysta sales more than doubled to £29
million. The successful development and commercialization of
Benlysta for the additional indication would boost its sales
We remind investors that in Aug 2012, Glaxo completed the
acquisition of Human Genome Sciences for $14.25 per share in
cash. With this acquisition, Glaxo gained full control over
Benlysta and late-stage candidates, such as Eperzan
We note that Glaxo has a robust pipeline. The company is seeking
approval for several candidates including Relvar/Breo (chronic
obstructive pulmonary disease/COPD and asthma, target date: May
12, 2013), Anoro (COPD, target date: Dec 18, 2013), dolutegravir
(HIV, target date: Aug 17, 2013), Eperzan (type II diabetes),
dabrafenib (oncology) and trametinib (oncology). We believe that
Glaxo's pipeline must deliver since many of its products are
facing declining sales due to generic competition.
Glaxo, a large cap pharma stock, carries a Zacks Rank #3 (Hold).
Large-cap pharma companies that currently look better-positioned
) carrying Zacks Rank #2 (Buy). Other pharma stocks that look
Osiris Therapeutics, Inc.
). Both are Zacks Rank #1 (Strong Buy) stocks.
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