GSK files diabetes drug in Europe in big regulatory offensive

GlaxoSmithKline ($GSK) has snapped in another piece to its regulatory puzzle, filing its once-weekly Type 2 diabetes treatment albiglutide for an approval in Europe. The treatment is one of a slate of six therapies that the Big Pharma company now has under review on both sides of the Atlantic. And they provide GSK with the chance to argue that its multibillion-dollar R&D effort has begun to pay off.

Albiglutide, though, represents both the strengths and weaknesses of GSK's research initiative. It's an injectable GLP-1 therapy, just like Victoza from Novo Nordisk ($NVO), and the Byetta/Bydureon pair from Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN). GSK filed for U.S. approval in January, completing its regulatory slate.

The drug is looking like a definite plus for GSK, but not a blockbuster. Thomson Reuters Pharma notes that among analysts the average sales estimate for the drug is $285 million. 

Moncef Slaoui, GSK's R&D chief

Why so low? Like Breo, a next-gen therapy for COPD from Glaxo and Theravance ($THRX), albiglutide may have good odds at an approval, but it is likely to face some heavyweight competition from competing therapies. That was exactly the point that GSK R&D chief Moncef Slaoui made in a remarkable interview with Dow Jones recently. Noting that this batch of drugs under review aren't market "firsts," he's looking to late-stage drugs like the heart drug darapladib and the cancer drug MAGE-A3 to win kudos as breakthrough therapies.

- here's the press release

Special Reports: GlaxoSmithKline - The Biggest R&D Spenders In Biopharma | Top diabetes drug pipelines of 2012

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