GSK pilots its 6th drug to regulators in critical R&D offensive

A key piece of GlaxoSmithKline's late-stage turnaround plan fell into place today as the pharma giant announced that it had filed the once-weekly diabetes drug albiglutide for approval at the FDA. The filing gives GSK ($GSK) an impressive slate of 6 new drugs up for regulatory review and the chance to boast about the productivity of its restructured R&D operation.

Any approval for albiglutide, though, won't be easy to capitalize on. The GLP-1 class of drugs--which are designed to spur production of insulin when a diabetic's blood sugar climbs--already includes Bydureon and Byetta as well as Novo Nordisk's ($NVO) Victoza. Sanofi ($SNY) already won a recommendation for Lyxumia, leaving GSK angling for a spot in what GSK's Patrick Vallance frankly deemed a "crowded market" at J.P. Morgan last week.

Thomson Reuters notes that the average peak sales forecast for the drug is an anemic $367 million, Reuters reports. A European application for albiglutide is expected soon.

Vallance, who heads up pharmaceuticals research and development, concentrated heavily on GSK's regulatory offensive in San Francisco last week. And he had good reason to. The Big Pharma's stock price has been under pressure as analysts fret over the company's ability to bring in the new products that will be needed to shore up its wavering sales figures. 

GSK reengineered its R&D operations close to four years ago to focus investigators on the most promising new therapies in the pipeline. That has produced applications for the lung drugs Anoro and Relvar, the skin cancer drugs dabrafenib and trametinib, the HIV therapy dolutegravir and now albiglutide.

The R&D spotlight is now turning to 14 late-stage therapies, with the melanoma vaccine MAGE-A3 and darapladib for heart disease as two of the most promising treatments in Phase III. Last week Vallance called MAGE-A3 a "potential game changer" if the late-stage program delivers positive results. 

- here's the press release
- read the story from Reuters

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

Suggested Articles

Fifteen of the 22 patients in a gene therapy trial no longer needed transfusions, while the remainder needed fewer transfusions.

Argos Therapeutics is ending its kidney cancer trial and mulling options, including a merger or sale, to stay alive.

CNS Pharma says berubicin is the first anthracycline drug to cross the blood-brain barrier and could transform treatment of the highly invasive brain tumor.