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GSK says new data support filing of diabetes drug

By Ben Hirschler

LONDON (Reuters) - GlaxoSmithKline will push ahead with plans to file its experimental once-weekly diabetes drug albiglutide for regulatory approval, following the read-out from a series of clinical trials.

Albiglutide belongs to the same class of injectable GLP-1 medicines as Novo Nordisk's Victoza and Byetta, from Amylin Pharmaceuticals and Eli Lilly. Byetta was the first drug of the type.

Last November, GSK reported that albiglutide cut blood sugar less than daily Victoza in the first of a series of late-stage clinical trials, dimming its prospects in an increasingly competitive market.

However, the company said on Tuesday that top-line data from seven of eight Phase III clinical studies had now been received and, taken together, the results supported progression of the medicine towards regulatory filings in type-2 diabetes.

The news marks the second fillip to GSK's pipeline in two days, following positive results with a new HIV/AIDS drug on Monday - although neither product is expected to be transformational for its drugs business.

Analysts' forecasts for albiglutide currently point to modest annual sales of around $250 million by 2016, according to Thomson Reuters Pharma.

Details were not disclosed for most of the studies, as the majority have not yet completed, but GSK did announce findings from one trial testing albiglutide against Lilly's insulin drug Humalog given on top of Sanofi's Lantus.

In that trial, patients taking albiglutide plus Lantus experienced a 0.82 percentage point reduction in HbA1c, a measure of blood sugar, while the group on Humalog plus Lantus had a reduction of 0.66. The albiglutide patients also lost an average 0.73 kg in weight while the others gained 0.81 kg.

By the end of 2012, GSK expects to have all the Phase III data required to support regulatory filing in house. The company did not specify when exactly it aimed to submit albiglutide for regulatory approval.

Novo's Victoza is currently market leader in the GLP-1 market but rival treatments are waiting in the wings, including Lyxumia from Sanofi. Amylin also has a once-weekly follow-on to Byetta called Bydureon.

Glucagon-like peptide-1, or GLP-1, drugs work by stimulating insulin release when glucose levels become too high. Their ability to induce weight loss is an added benefit, since type-2 diabetes is linked to obesity.

Albiglutide was previously also known as Syncria but GSK no longer uses that brand name.

(Reporting by Ben Hirschler; Editing by Mark Potter)

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