GlaxoSmithKline Plc’s (GSK) experimental diabetes medicine albiglutide didn’t work better than Takeda Pharmaceutial Co.’s (4502) Actos medicine and showed higher rates of gastrointestinal side effects in a study.
Albiglutide didn’t achieve non-inferiority to Actos in a late-stage study dubbed Harmony 5, Glaxo said in a statement today. The results add to evidence from another trial, Harmony 3, where albiglutide lowered blood sugar better than Merck & Co.’s Januvia or Sanofi’s Amaryl, while more patients reported gastrointestinal side effects.
The findings add to mixed results released so far by Glaxo, which has conducted eight late-stage studies on albiglutide. Glaxo has said the drug failed to help diabetics control their blood sugar as well as Novo Nordisk A/S (NOVOB)’s Victoza in another trial.
“The data suggest that albiglutide is unlikely to be sufficient for it to be a serious competitor in the market,” said Sam Fazeli, a London-based analyst at Bloomberg Industries. “There is a small risk that the regulators would say that the the risk-benefit profile isn’t supportive of approval.”
Glaxo submitted albiglutide to U.S. regulators in January and to European regulators in March. The company has said it’s seeking a partner to help market the drug.
Albiglutide’s once-weekly dosing would make the drug more convenient for patients compared with existing once-daily treatments. Still, it will face challenges as it enters a “crowded area,” Patrick Vallance, Glaxo’s head of pharmaceuticals research and development, said in an interview.
Sales of albiglutide may reach $301 million in 2016, according to the average of nine analysts’ estimates compiled by Bloomberg. Avandia, once the world’s best-selling diabetes pill with peak annual sales of of about $3 billion for Glaxo, was withdrawn from the market in Europe in 2010 and sales were limited in the U.S. because of an increased risk of heart attacks.
To contact the reporter on this story: Makiko Kitamura in London at firstname.lastname@example.org
To contact the editor responsible for this story: Phil Serafino at email@example.com