) recently announced the submission of a marketing application to
the US Food and Drug Administration (FDA) for its diabetes
candidate albiglutide. The companies are looking to get the
candidate approved for treating adults suffering from type II
diabetes (once weekly).
The company is planning to submit a regulatory application to
the European Medicines Agency (EMA) in early 2013.
The marketing application includes data from a phase III study
(Harmony 8). We note that in Jul 2012, Glaxo reported encouraging
results from the Harmony 8 study, which evaluated albiglutide
) Januvia (sitagliptin). Approximately 507 type II diabetes
patients with renal impairment were enrolled in the study. The
drugs were compared on the basis of reduction in HbA1c, an
indicator of glucose level in the blood. Albiglutide showed a
statistically significant reduction in HbA1c from the baseline.
Results showed that the reduction in HbA1c for albiglutide and
Januvia arm were 8.08% and 8.22%, respectively. Additionally, the
rate of weight loss was higher in the albiglutide arm.
A few weeks ago, Glaxo and its partner
) announced the submission of a marketing application to the EMA
for their pipeline candidate UMEC/VI (proposed trade name:
Anoro). The companies are looking to get the candidate approved
in the EU as a maintenance bronchodilator therapy (once daily) to
relieve symptoms in adults suffering from chronic obstructive
pulmonary disease (COPD).
Glaxo/Theravance are also seeking US approval of the candidate
for the COPD indication. Last month, the companies announced the
submission of a marketing application with the FDA seeking
approval of UMEC/VI for the COPD indication.
We are positive on advancement of Glaxo's pipeline programs.
We believe the candidates hold immense commercial potential.
We currently have a Neutral recommendation on Glaxo, which
carries a Zacks Rank #3 (Hold). Large-cap pharma companies that
currently look better-positioned include
Johnson & Johnson
). All three are Zacks Rank #2 (Buy) stocks.
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