June 6, 2008 / 5:36 PM / 11 years ago

Novo Nordisk diabetes drug tops Byetta in trial

NEW YORK (Reuters) - Novo Nordisk’s experimental type 2 diabetes drug, liraglutide, was superior in controlling blood sugar in a clinical trial to Eli Lilly and Co and Amylin Pharmaceuticals Inc’s Byetta, the Danish company said on Friday.

In the 26-week head-to-head trial involving 464 people with type 2 diabetes, patients who got liraglutide once a day achieved a more than 1.1 percentage point reduction in HCA1c levels — a key measure of blood sugar — compared with a reduction of less than 0.8 percentage point for Byetta, which is administered twice a day.

The results were deemed to be statistically significant, Novo Nordisk said. Shares of Amylin fell nearly 9 percent.

“This was great data, so I couldn’t be more thrilled,” Novo Nordisk CEO Lars Rebien Sorenson said in an interview.

Liraglutide led to significantly more patients meeting both the American Diabetes Association HCA1c target of less than 7 percent and the guideline of less than or equal to 6.5 percent set by the American Association of Clinical Endocrinologists, Novo said.

Nearly 55 percent of liraglutide patients reached the ADA target compared with close to 45 percent on Byetta, known chemically as exenatide. About 35 percent in the liraglutide group hit the more stringent AACE target compared with about 20 percent on Byetta.

Novo applied for U.S. and European approval of its closely watched liraglutide last month. Lilly and Amylin are developing a longer acting version of Byetta called Byetta LAR that analysts believe will likely stack up better against liraglutide than the currently available twice a day Byetta.

Thomas Russo, an analyst with Robert W. Baird, said he expected data to be unveiled at the ADA meeting this weekend would suggest a long acting Byetta would be superior to liraglutide.

“We consider this comparison more relevant to the future competitive landscape,” Russo, who rates Amylin stock “outperform,” said in a research note.

“We need to see full data of how (Byetta) LAR stacks up before we can make a real determination,” Sorenson said. “But there’s no question that Amylin and Lilly is pushing ahead so that they can get the lead again with LAR and we are determined to stay ahead as we seem to getting once liraglutide is approved.”

He said the real challenge will be convincing patients who prefer pills to instead take the injectable GLP-1 class of medicines to which liraglutide and Byetta both belong.

“Beating Byetta is not the objective, its expanding the market,” Sorenson said.

He knows most patients would choose a pill over a needle.

“In this case you are trading the tablet with less efficiency for something that has less convenience, but more efficacy. I think it’s a pretty compelling choice,” Sorenson said.

Patients in both groups of the study lost an average of 3 kilograms (6.6 pounds). Weight loss is a highly desirable result in a diabetes treatment as obesity is a major cause of the disease. Some older drugs cause weight gain.

The overall rate of hypoglycemia, or dangerously low blood sugar, was low in both groups. The rate of minor hypoglycemia was statistically significantly lower in the liraglutide group, Novo said.

Sorenson said weight loss and no risk of hypoglycemia will also help make the case for the GLP-1 class.

“That is also very positive compared to other potent drugs,” he added.

Both drugs were administered as an add on to patients’ existing treatments.

Liraglutide works by stimulating the release of insulin only when glucose levels become too high.

Amylin shares closed down $2.84, or 8.7 percent at $29.93 on the Nasdaq in response to the Novo-sponsored study. Shares of Lilly, a much larger drug company, closed off $1.04, or 2.1 percent, at $48.42 on the New York Stock Exchange.

additional reporting by Lewis Krauskopf; editing by John Wallace and Carol Bishopric

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