Roche Xenical four-year type II diabetes prevention data may help increase the number of patients who are reimbursed for the weight-loss drug.

Roche has been examining ways to add a diabetes claim to Xenical (orlistat) since withdrawing a supplemental NDA for the indication in the first quarter (¹ Also see "Xenical Diabetes sNDA Withdrawn; FDA, Roche Disagree On Wording" - Pink Sheet, 11 March, 2002., p. 23). The company is no longer pursuing a diabetes indication in the U.S. and is instead concentrating on including data in labeling.

Diabetes data in labeling could help health plans justify reimbursing patients for Xenical. Currently, 42% of patients receive some coverage for the drug.

The 3,304-patient XENDOS study (XENical in the prevention of Diabetes in Obese Subjects) may provide an opportunity to include diabetes prevention data in the clinical trials section of labeling through an sNDA.

XENDOS showed a 37.3% reduction in the risk of developing type II diabetes in obese patients. After four years, the cumulative rate of disease as measured by a two-hour oral glucose tolerance test was 6.2% in the 120 mg Xenical group versus 9% in placebo.

The data were presented at the International Congress on Obesity in Brazil Aug. 26 and are expected to be published in a peer-reviewed journal.

Roche discussed the potential of the XENDOS data ahead of its release during a first-half conference call Aug. 14. The diabetes prevention data "will give us ammunition in the way that we can develop the product," Pharmaceutical Head William Burns said.

Xenical sales fell 26% in the U.S. to about $73 mil. in the first half and declined 18% to $273 mil. worldwide. Burns acknowledged that Roche was not "particularly happy of the current position," but noted that "some of the other players are equally struggling."

Roche has also been considering a Xenical OTC switch. "We have been looking also at what would it take to move a brand, or part of the brand, into an OTC arena," Burns said. While a switch would not be an "immediate action," it could become one "over time."

Xenical is approved for type II diabetes in Canada and Australia, and Roche recently received EU approval to incorporate the data into labeling.

Roche Xenical Diabetes Data Could Provide Reimbursement Opportunity

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