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Amylin says Byetta outperformed Januvia in trial


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Amylin says Byetta outperformed Januvia in trial

BOSTON (Reuters) - Eli Lilly and Co and Amylin Pharmaceuticals Inc said on Tuesday that a trial of their diabetes drug Byetta, which was recently linked with six deaths from pancreatitis, reduced glucose levels more than a rival drug from Merck & Co.

Data presented at the annual meeting of the European Association for the Study of Diabetes in Rome, showed that in a four-week study, patients taking Byetta showed more efficient use of their body's insulin than those taking Merck's Januvia.

"There has been some confusion in the marketplace about the therapeutic differences between Byetta and Januvia," said Orville Kolterman, senior vice president of research and development at Amylin. "There have been questions from physicians asking why they should use Byetta because isn't Januvia just Byetta in a pill?"

Byetta is administered twice daily by injection. Januvia is taken once daily as a pill.

Amylin hopes that this trial - the first to directly compare Byetta and Januvia - will help show why it is worth patients' while taking the injections rather than the pill.

The 61-patient study compared the effect of Byetta and Januvia on glucose levels two hours following a meal. Results showed that patients treated with Byetta had significantly reduced glucose levels when compared with Januvia.

In the Byetta patients, glucose levels fell an average of 112 milligrams per deciliter of blood compared to a decline of 37 milligrams per deciliter for the Januvia cohort.

Byetta was launched in 2005. It is a member of a class of drugs known as GLP-1 drugs, which are designed to stimulate the release of insulin when glucose levels become too high.

Diabetics do not produce enough insulin, or their bodies do not use it effectively, which can cause blood sugar to rise and damage blood vessels and organs. In patients with type II diabetes, the most common form, both problems exist.

Other companies developing drugs in the same class include Novo Nordisk and Roche Holding AG.

A shadow hangs over the class following the recent revelation that Byetta was linked with six deaths due to inflammation of the pancreas. Shares of Amylin have fallen roughly 33 percent since news of the deaths emerged last month. They have fallen 61 percent since reaching a year high of $51.10 last October.

On Monday alone, the company's shares fell more than 6 percent following the release of data showing that in the first nine weeks of the quarter, new prescriptions of Byetta were down 2.3 percent compared with the same period a year earlier, according to Lazard Capital Markets.

Weekly prescriptions of Januvia over the same period were up 8.9 percent.

"We continue to believe strong demand for Januvia, and not pancreatitis, will pressure Byetta growth, pushing Byetta more towards third- or fourth-line treatment options," said Lazard analyst Matthew Osborne in a research note.

But Amylin believes its latest trial will help reverse that trend.

"This data will clearly help physicians understand the difference between Byetta and Januvia and that physicians will therefore see the added benefit of Byetta, which should translate into additional use," Kolterman said.

Januvia is a member of a class of drug known as DPP-IV inhibitors.

© 2008 Reuters Health.

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