Denmark-based Zealand Pharma has announced that the first LixiLan Phase III trial protocol has been approved, triggering a $15m payment from Sanofi.
The payment was made by Sanofi under a licensing agreement with Zealand Pharma covering Lyxumia (lixisenatide) and any combination product including lixisenatide.
Discovered by Zealand, lixisenatide is intended for treatment of type 2 diabetes.
Under the deal, worldwide development and commercial rights to the product are exclusively licensed to Sanofi.
LixiLan is a once-daily single injection Lantus (basal insulin) / Lyxumia (lixisenatide) combination product and the Phase III development is scheduled to start in the first quarter of 2014.
Further to the start of Phase III development of LixiLan, Sanofi also confirmed that Lyxumia is being introduced progressively in a larger number of countries as a new once-daily prandial GLP-1 agonist therapy for patients with type 2 diabetes.
The company said that as well as its pronounced effect on lowering meal related glucose (post-prandial glucose, PPG), Lyxumia has a beneficial effect on body weight and has a limited risk of hypoglycemia.
Zealand Pharma chief executive officer David Solomon said: "This news is fully in line with Sanofi’s expectations to start Phase III development in the first quarter of 2014.
"Zealand believes that the combination of Lyxumia with Lantus, Sanofi’s blockbuster product and the worldwide-leading basal insulin, into one single device has an exciting potential, in our view also adding to the validation of the therapeutic relevance of Lyxumia, the first Zealand invented product on the market."
As part of the licensing deal, Zealand is eligible to receive $160m in remaining milestones from Sanofi.
In addition, Zealand will receive tiered low double-digit percentage royalties on Sanofi’s global sales of Lyxumia and fixed low double-digit percentage royalties on global full net sales of the Lyxumia/Lantus combination product.