Glaxo's diabetes drug fails to beat Takeda's Actos in head-to-head study

CHICAGO--GlaxoSmithKline's ($GSK) experimental diabetes drug proved to be at least as good at controlling blood sugar as most--but not one--in a series of late-stage trials reported Monday, building on a body of mixed performances in clinical trials of the weekly therapy.

The London-based drug giant has already requested approval of the GLP-1 receptor agonist, called albiglutide, in the United States and Europe. Regulators have already approved three other GLP-1 drugs, including Novo Nordisk's ($NVO) Victoza, Bristol-Myers Squibb ($BMY) and AstraZeneca's ($AZN) Byetta/Bydureon and Sanofi's ($SNY) Lyxumia. That puts pressure on Glaxo to distinguish its own contender in the crowded field.

Glaxo's albiglutide showed non-inferiority on the blood-glucose score to Merck's ($MRK) Januvia as well as Sanofi's Lantus and Amaryl. But not to Takeda's oral drug Actos, which is now generic and available on the cheap. And one miss out of 5 would seem more impressive had Eli Lilly's ($LLY) similar drug, dulaglutide, not outshone all active comparator drugs in a slate of trials reported here at the American Diabetes Association's annual meeting in recent days, including Byetta.

In a previous late-stage study, Glaxo's drug fell short of the glucose-lowering effects of Novo's daily GLP-1 drug Victoza, which is the biggest seller in the class. Lilly's similar drug is in a late-stage study to compare its safety and effectiveness to Victoza, with results expected in the next 6 months or so.

Glaxo has also fallen short in some comparisons of the safety of albiglutide to other diabetes drugs, and the side effect profile was hoped to be one of ways the program might set itself apart from the rest of the pack. However, the late-stage studies reported over the past several days show that patients on GSK's therapy suffered more gastrointestinal side effects than patients on Actos, Januvia and Lantus.

"The data suggest that albiglutide is unlikely to be sufficient for it to be a serious competitor in the market," Sam Fazeli, a London-based analyst at Bloomberg Industries, as quoted by the company's news wire. "There is a small risk that the regulators would say that the the risk-benefit profile isn't supportive of approval."

As previously reported, Glaxo's pharma R&D chief, Patrick Vallance, acknowledged in a Bloomberg interview that albiglutide would find plenty of company in a "crowded" market for GLP-1 drugs.

Yet regulators are likely to review no fewer than three new GLP-1 drugs this year as Lilly, GSK and Sanofi seek approvals for their contenders. And Lilly's dulaglutide is the only one of the three that has show comparable effectiveness to Victoza.

"The new guy on the block, or the new agent in the armamentarium is looking to be dulaglutide, and the data are looking better than the other ones because the glycemic control is looking to be on par with Victoza 1.8 mg dose," Mads Krogsgaard Thomsen, Novo's chief scientific officer, said in an interview with FierceBiotech on Sunday.

As Bloomberg reported, analysts have relatively low expectations for Glaxo's drug with a consensus estimate of $301 million in sales by 2016. That number pales in comparison to the blockbuster sales of Victoza and revenue from Byetta and its long-acting version Bydureon.

- here's GSK's release
- see Bloomberg's article