) recently presented data from five phase III studies (Harmony 1
to 5) on its once-daily diabetes candidate, albiglutide at the
73rd scientific session of American Diabetes Association.
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In the five Harmony studies, albiglutide demonstrated significant
efficacy in reducing HbA1c, an indicator of glucose level in the
blood, versus placebo and/or active comparators (including
insulin, a sulphonylurea, a thiazolidinedione and a dipeptidyl
peptidase four inhibitor) after 1-2 years. The candidate met the
primary efficacy endpoint in these studies.
However, in the randomized, double-blind Harmony 5 study, which
evaluated the efficacy and safety of albiglutide versus placebo
) Actos (pioglitazone), albiglutide failed to show
non-inferiority to the comparator.
Earlier this year, Glaxo submitted a marketing application for
albiglutide (proposed trade name: Eperzan in the EU) to the
European Medicines Agency (EMA) and the US Food and Drug
Administration (FDA). The company is looking to get the candidate
approved for treating adults suffering from type II diabetes. We
note that the diabetes market is highly crowded with players like
Eli Lilly and Company
In recent quarters, Glaxo received approval for several drugs
including two melanoma drugs, Tafinlar (dabrafenib) and Mekinist
(trametinib) and chronic obstructive pulmonary disease drug, Breo
Ellipta. Moreover, Glaxo boasts of a robust pipeline. A number of
pipeline-related news is expected in the coming quarters.
However, we remain concerned about generic competition faced by
the key products of the company.
Glaxo carries a Zacks Rank #3 (Hold). Companies that currently
look attractive include Novo Nordisk, carrying a Zacks Rank #2