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2008
27 November 2008: Announcement no. 3, 2008: Zealand Pharma and Helsinn Healthcare S...
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Product Pipeline
Zealand's Pipeline comprises 1 compound in phase III, 1 compound in phase II, 2 c...
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.
Endogenous GLP-1 is released from the small intestine in response to food intake and stimulates insulin liberation from the pancreas when blood sugar levels are elevated. In addition, GLP-1 suppresses the production of glucagon (a hormone that stimulates release of stored sugar from the liver into the bloodstream) which also contributes to the normalization of blood glucose. Furthermore, GLP-1 delays gastric emptying and reduces appetite which are considered important effects for the lowering of body weight that has been observed consistently with this new class of drugs. Importantly, GLP-1 only stimulates the liberation of insulin when blood glucose levels are elevated, while it is devoid of activity when blood glucose is normal or low. This mechanism explains the low risk of hypoglycemia (low blood glucose levels) during treatment with GLP-1 agonists.
GLP-1 receptor agonists like ZP10 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).
ZP10 was outlicensed to Sanofi-Aventis in June 2003. 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 expects the following benefits for AVE0010 based on its mode of action:
- Better glycemic control with optimal dose
- Better tolerability and low rate of nausea
- Fast titration, QD vs. BID dosing
- Better weight reduction
- User-friendly, fixed-dose, ready-to-use with Sanofi-Aventis technology
Sanofi-Aventis has announced that clinical phase II trials with a prolonged release formulation of AVE0010 are due to start in the first half of 2008. Submission of NDA/MAA is scheduled for 2012.
See Zealand relevant part of Sanofi-Aventis' R&D presentation 17 September 2007
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