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Roche Touts Positive Data for Investigational Diabetes Drug


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-06-11-2008
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Swiss pharma giant Roche was abuzz at ADA, announcing that its new diabetes treatment is set for Phase III trials and commenting on future plans for failed CETP inhibitor dalcetrapib.

Amid the buzz of activity at this week's annual meeting of the American Diabetes Association, Roche—a company better known for its innovations in cancer—is placing bets on a foray into diabetes drugs. The company presented promising Phase II data on its lead diabetes compound taspoglutide, a dual action glucose control and weight loss injectable for Type II diabetes.

Luke Miles, head of strategic marketing for metabolic diseases at Roche told reporters on Tuesday that the treatment is now scheduled to begin Phase III trials. "We see metabolism as a large opportunity for patient needs," Miles said. "This is a disease that is growing, and growing rapidly, because of genetics, lifestyle and food choices."

The compound is based on a naturally occurring peptide in humans that is easily broken up with enzymes in the body. It regulates glucose by modifying it and making it resilient, which can stabilize glucagon-like peptide-1 in patients.

Roche presented two Phase II studies testing a range of doses, and concluded that 10mg and 20mg doses can help patients achieve their goal with minimal side effects of nausea and vomiting.

The drug showed that it could decrease blood glucose and facilitate weight loss in as little as eight weeks.

Striving for Compliance
According to Miles, the biggest challenge is to maintain patient compliance through 20 years of treatment with pharmaceuticals. To make compliance easier—and distinguish taspoglutide from the competition—the medication is delivered once weekly using a pen-style injector with a hidden syringe.

"Most patients aren't looking forward to taking an injectable drug," said Miles. "They are not Type 1 diabetics. With this population, a physician has to convince them to inject themselves."

When asked if the treatment could be used to protect beta cells lacking insulin receptors—a much discussed topic at this year's ADA meeting—Miles replied, "Protecting beta cells has been the Holy Grail—but that has been difficult to do. There was one study that generated a debate, but we need to see a study where people are treated long term and then have the drug withdrawn and [see how they react]."

Roche expects to file taspoglutide in 2010.

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