Roche Moves Investigational Diabetes Drug, Taspoglutide, Into Phase III Clini...( - Positive Phase II Results of Roch...),Health

- Positive Phase II Results of Roche and Ipsen's First Once-Weekly Human

GLP-1 Presented at the American Diabetes Association Meeting -

NUTLEY, N.J., June 10 /PRNewswire/ -- Roche and Ipsen's investigational type 2 diabetes drug taspoglutide (R1583) has been shown to provide significant improvements in glucose control and weight loss after only eight weeks of treatment(1,2) with a safety and tolerability profile that supports entry into Phase III. Taspoglutide, originating from Ipsen's research, is the first human once weekly glucagon-like peptide-1 (GLP-1) analogue. It is a compound similar to the natural hormone GLP-1 which has a key role in blood sugar regulation. Based on these promising Phase II results presented at the American Diabetes Association (ADA) meeting in San Francisco, Roche has made the decision to move taspoglutide into Phase III clinical trials with the program anticipated to start in the second half of 2008.

"These data reinforce the role of GLP-1 in type 2 diabetes and Roche and Ipsen believe taspoglutide has the potential to be a best-in-class treatment," said William M. Burns, CEO, Pharmaceuticals Division of Roche and Jean-Luc Belingard, Chairman and CEO of the Ipsen Group. "GLP-1 analogues, which stimulate insulin secretion and suppress glucagon secretion, are true innovations in the diabetes field. Roche and Ipsen are pleased to move this potentially best-in-class product into phase III trials and look forward to working together to bring it to market," they said.

The Phase II studies showed that the safety profile of taspoglutide supports the move to Phase III with the most common adverse event reported being mild-to-moderate nausea. These events were dose-dependent, and in most cases, resolved spontaneously while continuing on therapy.

"These data show that taspoglutide is a promising once weekly treatment for patients with type 2 diabetes mellitus no longer controlled on oral antidiabetic medica
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