CHMP Positive on Glaxo's Eperzan - Analyst Blog

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GlaxoSmithKline 's ( GSK ) diabetes candidate, Eperzan (albiglutide) has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). A final decision from the European Commission should be out by the end of this quarter.

The CHMP recommended the approval of Eperzan both as a monotherapy and as combination therapy in adults suffering from type II diabetes. The CHMP's positive recommendation was based on encouraging data from eight phase III trials on Eperzan.

Eperzan is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being developed as a once-weekly treatment for type II diabetes. We are encouraged with the CHMP recommendation on Eperzan, which can provide an edge over daily dosing regime of GLP-1 products including Novo Nordisk 's ( NVO ) Victoza among others. Currently, Bydureon is the only GLP-1 receptor agonist which has once weekly dosing.

 However, several big pharma companies like Novo Nordisk (semaglutide) and Eli Lilly and Company ( LLY ) (dulaglutide) have GLP-1 candidates with once weekly dosing in late-stage development.

Glaxo is also looking to get the drug approved in the U.S. as well where a decision should be out by Apr 15, 2014. The review period was extended by three months by the FDA to assess Glaxo's response to the FDA's requests.

Glaxo carries a Zacks Rank #3 (Hold). In the near term, we believe that investor focus will be on the release of its fourth quarter and full year 2013 results (Feb 5). Some better-ranked stocks include Allergan ( AGN ) carrying a Zacks Rank #2 (Buy).



ALLERGAN INC (AGN): Free Stock Analysis Report

GLAXOSMITHKLINE (GSK): Free Stock Analysis Report

LILLY ELI & CO (LLY): Free Stock Analysis Report

NOVO-NORDISK AS (NVO): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: AGN , CHMP , GSK , LLY , NVO

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