Pharma

GSK says diabetes drug’s initial phase 3 results support regulatory filing

GlaxoSmithKline’s (NYSE:GSK) experimental type 2 diabetes treatment albiglutide now has initial results from its seven remaining phase 3 studies of the compound and the company says the data support moving toward a regulatory filing for the drug. The initial positive results follow albiglutide’s failure last year in the first of eight total phase 3 studies. […]

GlaxoSmithKline’s (NYSE:GSK) experimental type 2 diabetes treatment albiglutide now has initial results from its seven remaining phase 3 studies of the compound and the company says the data support moving toward a regulatory filing for the drug.

The initial positive results follow albiglutide’s failure last year in the first of eight total phase 3 studies. Albiglutide failed in that trial to show it was as effective as Novo Nordisk’s (NYSE:NVO) Victoza, a blockbuster drug that generated more than $1 billion in 2011 sales. Once-weekly, injectable albiglutide would offer a dosing advantage to the once-daily Novo Nordisk injectable.

The remaining phase 3 clinical trials on albiglutide suggest that the GSK diabetes treatment still shows promise. Britain-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, did not release additional details on the trials except to say that taken together, the seven remaining phase 3 trials support a regulatory filing. The studies are investigating albiglutide’s efficacy, tolerability and safety, including cardiovascular safety. Since GSK’s former diabetes blockbuster drug Avandia fell under regulatory scrutiny due to links to cardiovascular problems, all diabetes drug developers are watching out for any cardiovascular risks.

Albiglutide is a biological, injectable form of human GLP-1, a peptide that helps the body maintain normal blood sugar levels and also helps control appetite.  People who have type 2 diabetes experience reduced GLP-1 secretion in response to a meal.  Albiglutide fuses human GLP-1 to human albumin, which is intended to potentially extend the duration of the drug. That means patients would need fewer frequent injections.

Albiglutide was created by GSK drug partner Human Genome Sciences (NASDAQ:HGSI) with proprietary albumin-fusion technology that was licensed to GSK in 2004. If albiglutide is approved and commercialized, HGS stands to gain fees and milestone payments up to $183 million, plus royalties. Even if albiglutide is approved, it is expected to only modestly take away from Novo Nordisk’s Victoza sales. Analysts told Thomson Reuters Pharma that they expect albiglutide would have more modest sales of around $250 million.

GSK expects the albiglutide phase 3 studies will complete by early 2013.