Doctors Say New Diabetes Drugs Hold Great Promise

By nearly every measure, it has been a successful weekend for a new wave of proposed drugs that doctors are hailing as the most promising medicines for the millions of patients suffering from Type 2 diabetes.

Studies released at this weekend's American Diabetes Association conference show proposed drugs from Novo Nordisk (NVO), Eli Lilly & Co. (LLY), Amylin Pharmaceuticals Inc. (AMLN), Alkermes Inc. (ALKS), and GlaxoSmithKline Plc (GSK) are better at helping Type 2 diabetes patients control their blood sugar and lose weight than most medicines currently on the market.

The drugs, referred to as GLP-1s, or "GLiPs" in industry jargon, also provide one benefit no other Type 2 diabetes medicines can: Patients need to take them just once a day or once weekly, as opposed to multiple times daily, a convenience factor doctors hail as extremely important for patients who often times forget, or neglect, to take treatments.

"The biggest problem we have in diabetes is adherence" to treatment schedules, Dr. John Buse said. Buse, a professor of medicine at the University of North Carolina, Chapel Hill, reviewed a study sponsored by Novo Nordisk about its proposed once-daily medicine, liraglutide. He has also consulted with many major pharmaceutical companies.

He said these new drugs are clearly "more powerful" than those taken multiple times a day, such as Byetta, marketed by Eli Lilly and Amylin.

"I think they are the most promising agents that we've seen yet for dramatically improving the health of people with Type 2 diabetes," he said.

Dr. Richard Kahn, chief scientific and medical officer of ADA, echoed those sentiments. "This is an exciting class of drugs that has great potential," he said.

Studies show they help Type 2 diabetes patients lose as much weight, though usually more, than current treatments. For instance, a two-year study involving Novo's liraglutide showed patients taking the drug lost an average of six pounds, while those taking Amaryl, by Sanofi-Aventis SA (SNY), gained about 2 pounds. In a separate study involving a once-a-week version of Byetta, patients lost an average of 5.8 pounds. Companies funded both studies.

One catch: Federal regulators haven't approved any of these drugs yet. Byetta, injected twice a day, has been on the market since June 2005 but the weekly version, called exenatide once weekly, is awaiting approval.

Novo's liraglutide appears to be the most ripe for approval. A European medicines commission has recommended the treatment be approved. European regulators rarely go against the medicines commission's recommendation.

Also, the drug appeared before a U.S. Food and Drug Administration panel in April, a key meeting for new drugs. The panel, composed of medical experts, was split on whether to recommend approval amid concerns the drug may be linked to a rare, but potentially serious type of thyroid cancer. Data Novo submitted to the FDA showed rodents tested with liraglutide grew tumors, which isn't uncommon in rats. The panel and the FDA, however, said it wasn't clear that the data from the rodents is relevant to humans.

Buse said it's "unlikely" the thyroid cancer concerns seen in rats treated with liraglutide will affect humans.

The timing of the new treatments also appears serendipitous. A popular class of diabetes drugs called TZDs, which include GlaxoSmithKline's Avandia and Takeda Pharmaceutical Co.'s (4502.TO) Actos, are coming under increased scrutiny amid concerns they are linked to increased heart risks.

-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; [e-mail]