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Roche discloses the results of first Phase III clinical study using Taspoglutide

http://www.roche.com/investors/ir_update/inv-update-2009-10-29.htm

First Phase III clinical trial of Roche's weekly taspoglutide meets primary end-point of change in HbA1c

Significant superiority on HbA1c versus twice-daily exenatide demonstrated in this head-to-head study

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that headline results from its Phase III study, T-emerge 2 (subcutaneous weekly taspoglutide versus subcutaneous twice-daily exenatide, as add-on to metformin, a thiazolidinedione [TZD], or metformin and a TZD), showed that the trial met its primary endpoint of change in HbA1c. Superiority versus exenatide was demonstrated.

“We are pleased that these results from our first head to head Phase III trial reinforce taspoglutide’s profile as a potential best-in-class GLP-1, supporting its use as an important and convenient new future therapy for patients with type 2 diabetes”, said Jean-Jacques Garaud, Head of Pharma Development, Roche.

The results showed that taspoglutide demonstrated superior HbA1c reduction versus exenatide following 24 weeks of treatment. The study analysis included 1189 patients, equally randomized into three active arms (taspoglutide 10 mg once weekly, taspoglutide 10 mg once weekly titrated up to 20 mg once weekly after 4 weeks, and exenatide 10 mcg twice daily). Taspoglutide was generally well tolerated. The most frequently reported adverse events among taspoglutide and exenatide treated patients were nausea and vomiting.

Data from T-emerge 2 will be submitted for presentation at upcoming international scientific meetings. In addition, seven other phase III trials exploring taspoglutide in patients with diabetes are ongoing.

Roche exercised its licensing option for taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market taspoglutide, except in Japan where these rights are shared with Teijin and in France where Ipsen may elect to retain co-marketing rights.
About T-emerge 2

T-emerge 2 is an open-label, 24-week core study, to demonstrate non-inferiority (with a pre-specified test for superiority) versus twice-daily exenatide, involving 1189 patients, equally randomized into three active arms (taspoglutide at doses of 10 and 20-mg, and exenatide 10 mcg). All patients continue into long-term extension of the study.
About the T-emerge Program

The T-emerge Phase III clinical trial programme is designed as multicenter, multi-country, randomized, controlled (active or placebo), double-blind and open studies. Over 6000 patients will be enrolled in the eight studies that comprise the T-emerge programme. Studies include two parallel taspoglutide arms including 10 mg once weekly and 10 mg once weekly titrated up to 20 mg once weekly after 4 weeks. Four of the eight studies have active comparators, including exenatide, sitagliptin, insulin glargine and pioglitazone.
About Taspoglutide...snip