Zealand announces that Sanofi's NDA for the fixed-ratio combination (LixiLan) of lixisenatide and insulin glargine for Type 2 diabetes has been accepted for review by the FDA

• FDA's acceptance includes Sanofi's redemption of a Priority Review Voucher with the NDA filing
• Based on a six months priority review process, a US regulatory decision is expected in August 2016
• Planned submission of the combination product in the EU in Q1 2016 confirmed by Sanofi

COPENHAGEN, Denmark, Feb. 22, 2016 -- Zealand announces that today, Sanofi has confirmed that their New Drug Application (NDA) for the once-daily, fixed-ratio combination of lixisenatide and basal insulin glargine 100 Units/mL has been accepted for review by the U.S. Food and Drug Administration (FDA). The combination product, referred to as LixiLan, is an investigational new type of treatment for adults with Type 2 diabetes.

As an essential component in the combination, lixisenatide is a once-daily prandial GLP-1 receptor agonist for the treatment of patients with Type 2 diabetes, invented by Zealand. Global development and commercialization rights to lixisenatide are licensed to Sanofi who markets the medicine as Lyxumia^(r) in 50 countries outside the US. In September, the FDA accepted Sanofi's NDA for lixisenatide in the US for regulatory review. Based on a standard review process of 10 months, a US regulatory decision on lixisenatide as stand alone medicine can be expected in July 2016. Insulin glargine is marketed by Sanofi as Lantus^(r) and is the worldwide most prescribed and established basal insulin.   

The NDA for LixiLan is based on results from two pivotal Phase III trials, conducted by Sanofi and involving more than 1,900 Type 2 diabetes patients worldwide. The objective was to evaluate the efficacy and safety of the fixed-ratio combination when used in patient populations insufficiently controlled with oral anti-diabetic agents (OADs) and with basal insulin, respectively. Both trials met their primary endpoint of significantly better blood glucose control (measured as the three months average, HbA1c) with LixiLan and results will be presented at a medical congress in 2016.

In a comment to this announcement, Britt Meelby Jensen, President and CEO at Zealand, said: "FDA's acceptance of Sanofi's NDA for LixiLan for priority review is a very important step in the regulatory process for this new type of diabetes medicine. I am convinced that the fixed-ratio combination of lixisenatide, invented by Zealand as a once-daily prandial GLP-1 agonist, and Lantus^(r), the world's most selling insulin, has attractive new therapeutic offerings for patients with Type 2 diabetes. With FDA's acceptance, Zealand has also come closer to the potential realization of the remaining milestones and royalty payments under our agreement with Sanofi, which will be important to accelerate the advancement of our proprietary specialty medicines for the benefit of patients and shareholders."