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Glaxo Seeks Albiglutide Approval

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GlaxoSmithKline (GSK - Free Report) 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 versus Merck’s (MRK - Free Report) 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 Theravance, Inc. 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 Eli Lilly (LLY - Free Report) , Johnson & Johnson (JNJ - Free Report) and Novartis (NVS - Free Report) . All three are Zacks Rank #2 (Buy) stocks.

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