GlaxoSmithKline (GSK - Free Report) 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.
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 and Takeda Pharmaceuticals’ 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 Novo Nordisk (NVO - Free Report) and Eli Lilly and Company (LLY - Free Report) .
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 (Buy).