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2008
12 February 2008: Press release no. 1, 2008: Phase III program for AVE0010/ZP10 licensed ...
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Pipeline with 1 compound in phase III, 2 compounds in phase II, 3 compounds in phase I and ...
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AVE0010/ZP10
ZP10 is a glucagon-like peptide 1 (GLP-1) receptor agonist that incorporates Zealand Pharma’s SIP®-technology and is targeted to treat Type 2 diabetes. It was outlicensed to Sanofi-Aventis in June 2003. GLP-1 receptor agonists normalize elevated blood sugar by enhancing insulin secretion until blood sugar levels approach normal concentration. This mode of action combines high anti-diabetic efficacy with low risk of hypoglycemia (insulin shock). In March 2005, Sanofi-Aventis completed the first Phase II clinical study on AVE0010/ZP10 in which the compound was safe and well- tolerated. In addition, anti-diabetic effects were observed after four weeks treatment with AVE0010/ZP10. In September 2007, Sanofi-Aventis published encouraging results from a double blind, placebo- controlled Phase IIb dose ranging study with AVE0010/ZP10 in metformin-treated patients with Type 2 Diabetes. Thirteen weeks of daily treatment with AVE0010/ZP10 demonstrated a dose-related decrease in glycosylated hemoglobin (HbA1c) and a significant reduction in body weight. A Phase III clinical study has commenced in the first half of 2008 and submission of NDA/MAA is expected to be filed in 2010.
Sanofi-Aventis has announced that clinical phase II trials with a prolonged release formulation of AVE0010/ZP10 are due to start in the first half of 2008. Submission of IND/MAA is scheduled for 2012.
See Zealand relevant part of Sanofi-Aventis' R&D presentation 17 September 2007
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