Biotech Values

[drbio45]

Exenatide pump controls glucose in short trial
Sat Jun 6, 2009 11:00am EDT
* Pump lowers glucose levels, HbA1c in 4-week study

no wonder Icahn wants to get AMLN sold

* Gap in Amylin patent coverage

By Deena Beasley

LOS ANGELES, June 6 (Reuters) - A pump-delivered version of exenatide, the active ingredient in diabetes drug Byetta, was shown to significantly lower glucose levels in a small four-week trial, according to Intarcia Therapeutics Inc., which is developing the product.

Venture capital-backed Intarcia is using technology involving a matchstick-size implantable pump that would deliver the biologic drug on a sustained basis for up to a year.

Byetta, given twice daily by injection, is marketed by Amylin Pharmaceuticals Inc (AMLN.O: Quote, Profile, Research, Stock Buzz) and Eli Lilly & Co (LLY.N: Quote, Profile, Research, Stock Buzz). The drug had 2008 sales of $751 million and the partners filed in May for U.S. regulatory approval of an exenatide formulation that would be dosed in a weekly injection.

But the companies do not have a composition of matter patent on exenatide or a claim that covers treatment of diabetes, according to Intarcia Chief Executive Alice Leung.

The implanted pump would give patients an immediate, optimized dose of exenatide with consistent, round-the-clock control of blood glucose without having to inject themselves, she said.

Byetta was launched in 2005. It is a member of a class 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 2diabetes, the most common form, both problems exist.

REDUCTION IN FASTING GLUCOSE

The trial found that for diabetes patients implanted with Intarcia's ITCA650, blood glucose levels fell 5.6 milligrams per deciliter of blood at the lowest dose and 28.8 mg/dL at the highest dose. Levels of HbA1c, a measure of glucose control, decreased by 0.5 to 0.6 percentage points.

The drug was also associated with weight loss.

"We saw an almost immediate reduction in fasting glucose," Leung said.

The results from the trial, which enrolled patients on a stable treatment regimen of diet and exercise or common oral diabetes drugs, were reported on Saturday at the annual meeting of the American Diabetes Association.

The 44-patient trial did not look at safety issues, but Byetta has been linked to several patient deaths due to inflammation of the pancreas, or pancreatitis, to which diabetes patients are more prone than the general population.

"If there is a concern, we can take the device out immediately," Leung said, contrasting such "reversible delivery" to the several weeks that it takes for Amylin's once-weekly exenatide to leave the body.

She also said patients using ITCA650 had less nausea than patients treated with Byetta.

Intarcia licensed rights to the Duros continuous drug delivery technology from Alza Corp in 2000, just before Johnson & Johnson's (JNJ.N: Quote, Profile, Research, Stock Buzz) acquisition of Alza.

Amylin and Lilly are using technology developed by Alkermes Inc (ALKS.O: Quote, Profile, Research, Stock Buzz) for once-weekly Byetta.

Intarcia expects to launch a 3-month Phase II trial of ITCA650 in the third quarter and a pivotal trial next year, but will need to sign on a development partner before the Phase III program, Leung said.

"We are a small company with just 41 people. It is not possible for us to cover the world," she said.


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