Roche, Ipsen diabetes drug meets goals in studies

ZURICH/LONDON, Dec 17

A weekly diabetes drug from Roche met its goals in two late-stage clinical trials, part of a series of studies required for approval, the Swiss drugmaker said on Thursday.

Roche, the world's largest maker of cancer drugs, licensed taspoglutide from France's Ipsen in 2006 and believes it can become a major seller in the so-called GLP-1 drug market.

The experimental medicine was as good as Sanofi-Aventis's daily insulin treatment Lantus, or glargine, in controlling blood sugar in one of the Phase III trials and better than a placebo in overweight patients in the other.

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 the drug, which they believe has a 60 percent probability of winning regulatory approval and could generate peak sales of $2 billion a year.

However, Sanford Bernstein analysts said some investors might be surprised to find taspoglutide was only "non-inferior" to Lantus while Novo Nordisk's Victoza and Eli Lilly and Amylin's Byetta LAR had both showed modest but statistically significant superiority.

Shares in Ipsen, for which taspoglutide is a key new product, had fell 1.5 percent by 1330 GMT. Roche was 0.7 percent higher.

Three more Phase III trials with taspoglutide 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 rival to Byetta and an experimental longer-acting version called Byetta LAR, as well as Novo'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.

Currently type 2 diabetes affects more than 180 million adults worldwide and the number is expected to escalate to over 360 million by the year 2030, Roche said.

-Reuters