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 Avandia, once the world’s best-selling diabetes pill with peak annual sales of of about $3 billion for Glaxo, was withdrawn from the market in Europe in 2010 and sales were limited in the U.S. because of an increased risk of heart attacks.
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