Investor Update
Basel, 17 December 2009
Roche’s weekly taspoglutide meets primary end-points in two further head-to-head Phase III clinical trial comparisons with insulin glargine (Lantus®) and also versus placebo in patients with high body mass index (BMI)
Taspoglutide demonstrates non-inferiority HbA1c change versus insulin glargine and superiority in HbA1c change versus placebo
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced headline results from the fourth and fifth of eight T-emerge Phase III studies with both studies meeting their primary endpoints.
The results of T-emerge 5 (a head to head comparison study of subcutaneous weekly taspoglutide versus insulin glargine) showed that taspoglutide demonstrated non-inferiority in HbA1c change versus insulin glargine. The study analysis included 1,049 patients, randomized into three arms (taspoglutide 10 mg once weekly, taspoglutide 20 mg once weekly and insulin glargine once daily). The average final dose of Lantus® was 37 units.
T-emerge 7 (subcutaneous weekly taspoglutide versus placebo in patients with high body mass index [BMI] patients) showed that taspoglutide demonstrated HbA1c superiority versus placebo in patients with high BMI. The study analysis included 305 patients, randomized into two arms (taspoglutide 20 mg once weekly and placebo).
In both studies taspoglutide was generally well tolerated and the most frequently reported adverse events among taspoglutide treated patients were nausea and vomiting.
In addition to the already released T-emerge 2, T-emerge 1 and T-emerge 4 studies, data from T-emerge 5 and T-emerge 7 will be submitted for presentation at upcoming international scientific meetings. A further three T-emerge 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 5
T-emerge 5 is a head-to head comparison study of taspoglutide versus insulin glargine (Lantus®) as add-on to metformin in patients failing on metformin and sulfonylurea. T-emerge 5 is an open label and active controlled, 24 week core study to demonstrate non-inferiority versus insulin glargine, with 1,049 patients equally randomized into three arms (taspoglutide at doses of 10 mg and 20 mg, and insulin glargine once daily. All patients continue into the long-term extension.
About T-emerge 7
T-emerge 7 is a combination therapy study of taspoglutide as add-on to metformin in patients with high BMI. T-emerge 7 is a double-blind, placebo-controlled, 24 week core study, to demonstrate superiority versus placebo, involving 305 patients equally randomized into two arms (taspoglutide at a dose of 20 mg and placebo). All patients continue into the long-term extension.
About the T-emerge Programme
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 6,000 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 hypoglycaemia 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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