From Reuters Wire Service Stock Article

Glaxo's GLP-1 diabetes drug beats Byetta in test
Sun Jun 7, 2009 10:15am EDTRelated NewsAmylin CEO sees once-weekly sales surpassing Byetta

Novo diabetes drug tops Byetta in comparison study
Mon, Jun 8 2009

Syncria shows promise in Phase II clinical trial

No sign of thyroid cancer problems in monkey tests

Glaxo embarked on 2-3 years Phase III programme

By Ben Hirschler

LONDON, June 7 (Reuters) - An experimental diabetes drug from GlaxoSmithKline (GSK.L) was more effective than Eli Lilly (LLY.N) and Amylin Pharmaceuticals' (AMLN.O) Byetta in controlling blood sugar, a mid-stage test unveiled on Sunday.

Glaxo's injectable Syncria belongs to the same class of medicines, called GLP-1s, as Byetta and Novo Nordisk's (NOVOb.CO) Victoza, which the Danish drugmaker expects to launch in Europe this summer.

Safety issues have recently clouded prospects for the GLP-1 drug class.

In a 356-patient Phase II clinical study, presented at the annual meeting of the American Diabetes Association, Glaxo's Syncria, given once weekly, reduced HbA1C -- a common measure of blood sugar -- by 0.9 percent compared to 0.5 percent for Byetta, which is injected twice daily.

Syncria also caused patients to lose 0.9-1.8 kilos in weight, depending on dose. Common side effects included nausea, vomiting and headache.

British-based Glaxo began a final-stage Phase III clinical programme for the new medicine at the beginning of 2009, which is expected to take two to three years to complete.

GLP-1s have been touted as potential multibillion-dollar sellers, given demand for new ways to fight a global epidemic of type two diabetes driven by rising obesity levels.

But recently doubts have grown about the drug class, after Novo's Victoza caused thyroid cancer in rats and there were cases of pancreas inflammation last year with Byetta.

In case of Syncria, Glaxo's vice president of clinical development Murray Stewart said the drug could not be tested on rats for technical reasons but ongoing studies using monkeys had shown no signs of thyroid problems.

He remains optimistic that GLP-1s will emerge as an important new treatment option for difficult-to-treat diabetics, since they are highly effective at controlling blood sugar levels and also help people lose weight.

Some analysts have predicted they will lose out to DPP-4 inhibitors, another novel type of treatment for diabetes.

"I think in four years time people will realise there is probably no risk with pancreatitis and the thyroid issue is more related to animals than it is to humans," Stewart said.

"There is scientific reason to believe these issues will not be real and the benefits of the GLPs compared to the DPP-4s will be demonstrated."