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Zealand announce advancement in clinical study

Danish Zealand has announced that a milestone has been achieved in the advance of Lixilan towards start of phase III development in the 1st quarter of 2014.

The milestone relates to the approval of the first phase III study protocol for Lixilan by a health authority, triggering a USD 15 million payment to Zealand.

Lixisenatide is a once-daily prandial GLP-1 receptor agonist invented by Zealand for the treatment of Type 2 diabetes. Worldwide development and commercial rights to the product are exclusively licensed to Sanofi.

The announced first LixiLan Phase III study protocol approval follows an update provided by Sanofi yesterday at the Annual J.P. Morgan Healthcare Conference, held in San Francisco, on the status of Lyxumia and LixiLan. As part of the update, Sanofi confirmed plans to start Phase III development of LixiLan in the 1st quarter of 2014, narrowing its earlier guidance of an expected start in H1 2014.

Further to this, in their presentation, 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. In addition to its pronounced effect on lowering meal related glucose (post-prandial glucose, PPG), Lyxumia has a beneficial effect on body weight and is associated with a limited risk of hypoglycemia. This profile makes Lyxumia particularly well suited for use as add-on therapy to basal insulin, including Lantus.

Welcoming the announced milestone of LixiLan Phase III advance and the update from Sanofi, David Solomon, Chief Executive Officer of Zealand Pharma, said: “We are very pleased to be able to share this important and confirmatory milestone of the first LixiLan Phase III protocol approval. This news is fully in line with Sanofi’s expectations to start Phase III development in the 1st 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.”

Under the license agreement with Sanofi, covering lixisenatide (Lyxumia) and any combination products including lixisenatide, Zealand is eligible to up to USD 160 million in remaining milestones. Further, 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.

Source: Zealand Pharma