Investor Update
Basel, October 29, 2009
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
Taspoglutide is the first once-weekly human glucagon-like peptide-1 (GLP-1) analogue being developed to address the important unmet needs of patients with type 2 diabetes. Taspoglutide is similar to the naturally occurring human hormone GLP-1 which plays a key role in blood glucose modulation while slowing down food absorption and suppressing appetite resulting in glycemic control, weight loss and no incremental risk of hypoglycemia. Taspoglutide is currently in Phase III clinical trials.
About Diabetes
Type 2 diabetes is a global epidemic growing at an exponential rate. Currently type 2 diabetes affects more than 180 million adults worldwide and the number is expected to escalate to over 360 million by the year 2030. Type 2 diabetes accounts for 90% to 95% of all diabetes cases and is causally linked to obesity; as many as 90% of type 2 diabetes patients worldwide are overweight or obese. Weight management is thus often an important clinical goal.
Even with available therapies, managing type 2 diabetes remains a challenge due to the multi-faceted nature of the disease, complex treatment regimens and the constant demand on life style modification. Many patients struggle with therapy related side effects such as weight gain and hyperglycaemia as a trade off for glucose control. Approximately two-thirds of patients fail to achieve an HbA1c < 7%, and nearly 90% of patients fail to reach the combined treatment goals of glucose control, blood pressure and lipids.
Uncontrolled type 2 diabetes can lead to severe complications such as cardiovascular diseases, stroke, blindness, amputations, and kidney failure, resulting in significant healthcare burdens to society. Therefore, new therapeutic advances in type 2 diabetes are targeted at achieving the multiple clinical goals of patients with type 2 diabetes while enhancing patient compliance and supporting the necessary lifestyle changes to improve long-term outcomes.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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