Over the last few months, quite a few drugs at
) have gained approval including Breo Ellipta (chronic
obstructive pulmonary disorder/COPD), Tafinlar and Mekinist (both
melanoma), and Tivicay (HIV).
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Glaxo is also working on expanding the labels of some of its
existing products. Last month, the European Commission (EC)
approved Tyverb in combination with
) Herceptin for the treatment of patients with metastatic HER2
positive breast cancer who have received prior Herceptin therapy.
The EC has also approved Revolade for an additional indication,
the treatment of thrombocytopenia (reduced platelet count) in
adults with chronic hepatitis C virus (HCV) infection to enable
the initiation of interferon-based therapy and achieve optimum
results. Interferon-based therapies are commonly prescribed
treatments for chronic HCV infection. We note that chronic HCV
infection can cause several blood-related disorders including
The approval came in on the basis of encouraging safety and
efficacy data from two randomized, double-blind, placebo
controlled and multi-center phase III studies, which enrolled
approximately 1,520 patients.
We remind investors that the U.S. Food and Drug Administration
(FDA) has already approved the drug (marketed as Promacta) in the
U.S. for the above mentioned indication in Nov 2012.
Promacta is also approved for idiopathic thrombocytopenic
purpura, in both the U.S. and EU. Glaxo has a research &
collaboration agreement with
Ligand Pharmaceuticals Inc.
) for this drug.
Promacta sales came in at £45 million in the second quarter of
2013, up 53% from the year-ago period. We are pleased with
Glaxo's label expansion efforts, which should boost sales
Glaxo, a large cap pharma stock, presently carries a Zacks Rank
#3 (Hold). However, other large cap pharma stocks like
Eli Lilly and Company
) and Roche currently look better positioned with a Zacks Rank #2
(Buy) and a Zacks Rank #1 (Strong Buy), respectively.