Sanofi and Zealand successfully complete second pivotal Phase III trial of LixiLan

French pharma company Sanofi (Euronext: SAN) has announced positive top-line results in the second pivotal study of insulin glargine and lixisenatide.

The LixiLan-L Phase III clinical trial met its primary endpoint in patients with type 2 diabetes treated with insulin glargine, marketed as Lantus, with or without metformin. The fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide, a GLP-1 receptor agonist, demonstrated statistically superior reduction in average blood glucose over the previous three months, compared with insulin glargine 100 units/mL. The fixed-ratio combination’s safety profile reflected those of insulin glargine 100 units/mL and lixisenatide.

Under the global license agreement with Sanofi, covering lixisenatide and LixiLan, Sanofi is responsible for all development and commercialization including the financing, while Denmark’s Zealand Pharma (Nasdaq OMX Copenhagen: ZEAL) is eligible to receive event-driven milestone payments and royalties on global sales. Remaining milestone payments amount to up to $160 million, while royalty payments correspond to tiered, low double-digit percentages of Sanofi's global sales of Lyxumia plus fixed low double-digit percentages of global full net sales of LixiLan.