Zealand reports Lyxumia(R) royalty revenue for Q1 2016 and submission by Sanofi of the fixed-ratio combination of insulin glargine (Lantus(R)) and lixisenatide for European registration

• Royalty revenue to Zealand from Sanofi's sales of Lyxumia^(r) (lixisenatide) amounted to DKK 6.5 million / EUR 0.9 million in Q1 2016
• In March 2016, Sanofi submitted as planned the fixed-ratio combination of basal insulin glargine (Lantus^(r)) and lixisenatide for regulatory approval in Europe
• Three important US regulatory events are expected in the next four months:
  • 25 May: FDA Advisory Committee hearing and recommendation on both lixisenatide and the fixed-ratio combination of insulin glargine and lixisenatide
  • July: Expected regulatory decision by the FDA on lixisenatide
  • August: Expected regulatory decision by the FDA on the fixed-ratio combination of insulin glargine and lixisenatide         

COPENHAGEN, Denmark, April 29, 2016 -- Zealand reports that royalty revenue to the company from Sanofi's global sales of Lyxumia^(r) (lixisenatide) outside the US amounted to DKK 6.5 million / EUR 0.9 million for the period from 1 January to 31 March 2016. This corresponds to an increase of 3% over the same period in 2015. In its Q1 2016 earnings release today, Sanofi reported that sales of Lyxumia^(r) grew 12.5% annually, measured at constant exchange rates.

Sanofi also confirmed that in March 2016, the fixed-ratio combination of basal insulin glargine (Lantus^(r)) and lixisenatide, a novel investigational medicine for the treatment of adults with type 2 diabetes was submitted as planned for regulatory approval in Europe.  

In a comment to this announcement, Britt Meelby Jensen, President and CEO at Zealand, said:

"We are pleased by the double-digit growth of sales of Lyxumia^(r) outside the US as reported by Sanofi for Q1 2016.  Important to note is that the US represents approximately 75% of the USD 4 billion global GLP-1 market and currently experiences the highest growth rate for this product class. Consequently, the FDA regulatory decision regarding lixisenatide, which is anticipated in July, will be an important factor for the expected further growth in our royalty revenue for this product.

" It is also good news that Sanofi as planned has filed for regulatory approval in Europe for the fixed-ratio combination of Lantus^(r) and lixisenatide. For this product in the US, we look forward to the FDA Advisory Committee hearing scheduled for 25 May and the subsequent FDA regulatory decision, which is expected in August. With three key regulatory events anticipated, we have some very important months ahead of us."