Investor Update
Basel, 2 December 2009
Results from two further Phase III clinical trials show that Roche’s weekly taspoglutide met its primary end-points in head to head study with sitagliptin (Januvia®) and versus placebo
T-emerge programme continues to show that taspoglutide provides potent and durable glycemic control with superiority versus Januvia
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced headline results from the second and third of eight T-emerge Phase III studies for taspoglutide. T-emerge 1 (subcutaneous weekly taspoglutide versus placebo in treatment-naïve patients) and T-emerge 4 (subcutaneous weekly taspoglutide versus sitagliptin versus placebo) both met their respective primary endpoints of change in HbA1c.
The results of T-emerge 1 showed that taspoglutide demonstrated superior HbA1c reduction versus placebo. The study analysis included 373 patients, enrolled into three arms (taspoglutide 10 mg once weekly, taspoglutide 10 mg once weekly titrated up to 20mg once weekly after 4 weeks, and placebo).
T-emerge 4 showed that taspoglutide demonstrated superior HbA1c reduction versus sitagliptin. The study analysis included 636 patients, enrolled into four arms (taspoglutide at doses of 10 mg and 20 mg, sitagliptin 100 mg and placebo) in a ratio of 2:2:2:1. In both studies taspoglutide was generally well tolerated.
The most frequently reported adverse events among taspoglutide treated patients were nausea and vomiting.
In addition to the already released T-emerge 2 study, data from T-emerge 1 and T-emerge 4 will be submitted for presentation at upcoming international scientific meetings. In addition, five 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 1
T-emerge 1 is a double-blind, randomized, placebo-controlled, 24 week study to demonstrate superiority of taspoglutide versus placebo in 373 treatment-naïve T2D patients.
About T-emerge 4
T-emerge 4 is a head to head comparison study versus sitagliptin (Januvia®) as an add-on to metformin. It is a double blind, active and placebo controlled, 24 week study to demonstrate the non-inferiority of taspoglutide to sitagliptin with a statistical test for superiority to placebo, involving 636 patients who have failed to reach their treatment targets with metformin.
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 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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