ZURICH/LONDON, Dec 17 (Reuters) - Swiss drugmaker Roche said on Thursday its weekly diabetes treatment taspoglutide met goals in two late-stage trials, part of a series of studies on the way to filing the drug for approval.
Roche, the world's largest maker of cancer drugs, licensed the product from French drugmaker Ipsen in 2006 and believes it can become a major seller in the so-called GLP-1 treatment market.
The experimental drug proved as good as Sanofi -Aventis's daily insulin treatment Lantus, or glargine, and produced better blood sugar control than placebo in patients with a high body mass index in the two Phase III tests, it said.
In both studies taspoglutide was generally well tolerated. The most frequently reported adverse events were nausea and vomiting.
Analysts at Jefferies said the latest data helped underpin confidence in taspoglutide, which they believe has a 60 percent probability of winning regulatory approval and could generate peak sales of $2 billion a year.
Three more advanced clinical trials are still ongoing. The drug is similar to the human hormone GLP-1, which plays a key role in blood glucose modulation while slowing down food absorption and suppressing appetite resulting in glycemic control, weight loss and no incremental risk of hypoglycemia.
Taspoglutide is a potential rival to Eli Lilly and Amylin's Byetta and its experimental longer-acting version Byetta LAR, as well as Novo Nordisk's Victoza, which is on sale in Europe but not the United States.
The GLP-1 drug class offers a new approach to fighting diabetes, but prospects for the medicines have been overshadowed by potential safety concerns, including a possible cancer link.
Those safety issues have delayed Victoza's approval in the United States, although the Danish drugmaker hopes to get a green light from the regulator by the end of this year.
Jefferies analysts said they expected preclinical carcinogenicity data on taspoglutide in the first quarter of 2010.
GlaxoSmithKline is also developing a GLP-1 drug called Syncria, while Sanofi has one known as AVE0010. |
