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Disappointment for GSK in first phase III trial of albiglutide

Rival drug to Novo Nordisk's Victoza fails to show non-inferiority

GlaxoSmithKline's (GSK) diabetes treatment albiglutide failed to show that it was not inferior to a rival drug from Novo Nordisk in a phase III trial, but the company says it still plans to file for approval.

Albiglutide is an injectable glucagon-like peptide-1 (GLP-1) agonist in the same class as Novo Nordisk's Victoza (liraglutide), which was approved for use in people with type 2 diabetes last year in the US and Europe and pulled in $705m in sales in the first nine months of 2011.

GSK hoped the phase III trial - called Harmony 7 - would show that once-weekly albiglutide was at least as a good as once-daily Victoza in reducing haemoglobin A1c (HbA1c), a standard measure of glucose control in diabetes.

The results showed however a reduction in HbA1c of 0.78 per cent for albiglutide compared to a drop of 0.99 per cent for Novo Nordisk's drug, which was a statistically significant reduction but did not meet the criteria for non-inferiority.

Moncef Slaoui, chairman of R&D at GSK, said the data "support the continued progression towards registration of albiglutide as a possible future once-weekly treatment for type 2 diabetes". He also pointed out Harmony 7 was just the first of eight ongoing phase III studies of the new compound, and a clear picture of albiglutide's efficacy versus Victoza has yet to emerge.

Showing that its once-weekly formulation was as effective as once-daily Victoza would have been a great result for GSK, positioning albiglutide as more patient friendly than Novo Nordisk's drug and a direct competitor to Eli Lilly and Amylin's once-weekly GLP-1 analogue Bydureon (exenatide).

Bydureon is a new formulation based on the active ingredient in Amylin's once-daily Byetta product, which is expected to make around $550m in revenues this year but has seen sales slip recently on competition from Victoza and oral anti-diabetic medications such as Merck & Co's Januvia (sitagliptin) and Lilly/Boehringer Ingelheim's Tradjenta (linagliptin).

Bydureon was approved in Europe last year and is awaiting registration in the US, although the FDA has asked for additional information on how the formulation affects the heart and is not due to deliver a verdict until January 2012. Meanwhile, Amylin is in the process of extricating itself from a decade-long collaboration with Lilly on its GLP-1 agonist franchise.

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

17th November 2011

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