Back to top

Analyst Blog

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

GlaxoSmithKline (GSK - Analyst 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 - Analyst 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. (THRX - Analyst Report) 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 - Analyst Report), Johnson & Johnson (JNJ - Analyst Report) and Novartis (NVS - Snapshot Report). All three are Zacks Rank #2 (Buy) stocks.

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

Learn more

Start for as little as $4.50 per trade.

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
DIXIE GRP IN DXYN 15.84 +7.90%
BOFI HLDG IN BOFI 85.30 +4.97%
RAMBUS INC RMBS 12.31 +4.41%
VIPSHOP HOLD VIPS 148.73 +4.35%
NETFLIX INC NFLX 345.74 +4.32%