A milestone has been achieved in the advance of LixiLan, the once-daily single injection Lantus® (basal insulin) / Lyxumia® (lixisenatide) combination product, towards start of Phase III development in the 1st quarter of 2014.
The first milestone payment was given to Zealand Pharma in Febuary 2012.
A milestone payment of USD 20 million to be received from Sanofi following the successful completion of the global GetGoal Phase III clinical trial program for lixisenatide.
Lixisenatide is a once-daily investigational GLP-1 agonist for the treatment of Type 2 diabetes, invented by Zealand Pharma and licensed to Sanofi.
The drug candidate has been assessed by Sanofi in the GetGoal program, which involved more than 4,500 patients with Type 2 diabetes.
Zealand Pharma announced positive top-line results reported by Sanofi from the GetGoal-P Phase III study, showing that lixisenatide significantly improved blood glucose levels.
Throughout the GetGoal Phase III program, lixisenatide has delivered positive results, supporting the efficacy and safety of the drug as a monotherapy, in combination with oral anti-diabetes drugs and in combination with basal insulin.
In June 2003, Aventis and Zealand have signed a pharma licensing agreement for the development and worldwide commercialization of ZP10, a GLP-1 receptor agonist of the exendin class that offers the potential to become a novel way of treating type 2 diabetes.
ZP10 is currently in phase I/II clinical trials.
Aventis will receive the global rights to ZP10 and will be fully responsible for all further development, regulatory approval, manufacturing, marketing and sales of this compound.
Zealand will receive an upfront payment of $10 million, and total milestone payments could total up to $100 million.
Zealand would receive royalties on future product sales.
In April 2006 Sanofi-Aventis initiated a double blind, placebo controlled Phase II dose ranging study for the GLP-1 Agonist AVE0010 (ZP10) in Metformin-treated patients with Type 2 Diabetes, which was licensed from Zealand Pharma in 2003.
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