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GSK on track for albiglutide filing on phase III data

Investigational diabetes drug shows positive results in seven of its eight late-stage clinical trials

GlaxoSmithKline has said it intends to move ahead with regulatory submissions for its investigational diabetes drug albiglutide, after reporting positive results in seven of eight phase III trials in its Harmony clinical programme.

Albiglutide is a glucagon-like peptide-1 (GLP-1) agonist, in the same class as Amylin Pharmaceuticals' Byetta (exenatide) and Novo Nordisk's Victoza (liraglutide), but with more favourable dosing.

Byetta was the first GLP-1 agonist to reach the market and is given twice-daily, while market leader Victoza requires once-daily administration. GSK's phase III studies suggest that albiglutide will be able to exert its effects with just once-weekly dosing, thanks to the fusion of the GLP-1 component to human albumin.

That would allow albiglutide to compete with Amylin's once-weekly exenatide formulation, called Bydureon, which was approved in Europe last year and in the US in January.

Last year, GSK reported top-line data from a study (Harmony 7) intending to show that albiglutide was non-inferior to Victoza, but failed to reach that objective. At the time, GSK's  chairman of R&D Moncef Slaoui said a clearer picture of albiglutide's clinical profile would emerge once the other Harmony studies delivered results.

The company says it has now completed a second study (Harmony 6) showing that the drug is at least as good as Eli Lilly's Humalog (insulin lispro) when given on top of baseline treatment with Sanofi's long-acting Lantus (insulin glargine).

It has also collected interim data from five other studies (Harmony 1-5) which "provide an early indication of the profile of the investigational product, broadly aligned with the results of the two completed studies," according to GSK.

These studies will complete early next year, but Harmony 8 is scheduled to complete earlier in mid-2012.

Albiglutide was originally licensed to GSK by Human Genome Sciences in a $183m deal announced in 2004.

Analysts at JPMorgan have indicated they believe the drug's commercial prospects are limited because of the comparative data with other GLP-1 agonists, but could still achieve sales of around £450m ($715m) a year, according to a Dow Jones report.

4th April 2012

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