) recently announced the submission of a marketing application to
the European Medicines Agency (EMA) for its diabetes candidate
Eperzan (albiglutide). The company is looking to get the
candidate approved for treating adults suffering from type II
diabetes (once weekly).
A few weeks back, in Jan 2013, Glaxo had submitted a Biologics
License Application (BLA) for Eperzan to the US Food and Drug
Administration (FDA) seeking approval for the above mentioned
The marketing application includes data from a phase III study
(Harmony 8). We note that in Jul 2012, Glaxo had reported
encouraging results from the Harmony 8 study, which evaluated
) 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
Eperzan showed a statistically significant reduction in HbA1c
from the baseline. Results showed that reduction in HbA1c in the
Eperzan and Januvia arms were 8.08% and 8.22%, respectively.
Additionally, the rate of weight loss was higher in the Eperzan
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Glaxo boasts a strong late-stage pipeline. The company is already
seeking approval for several candidates including Relvar/Breo
(chronic obstructive pulmonary disease/COPD and asthma), Anoro
(COPD), dolutegravir (HIV), dabrafenib (oncology) and trametinib
We are positive on the advancement of Glaxo's pipeline programs.
We believe the candidates hold immense commercial potential.
Glaxo carries a Zacks Rank #4 (Sell). Large-cap pharma companies
that currently look better-positioned include
Eli Lilly and Company
). Both are Zacks Rank #2 (Buy) stocks.