Zealand's interim report for the first quarter of 2016 (unaudited)

  • Financial results in line with full year guidance
    • Revenue of DKK 6.5 million / EUR 0.9 million, of which Lyxumia(r) royalties of DKK 6.5 million / EUR 0.9 million
    • Net operating expenses of DKK 70.3 million / EUR 9.4 million
    • Net loss of DKK -72.8 million / EUR -9.8 million
    • Cash position of DKK 471.5 million / EUR 63.3 million as of 31 March 2016
  • Important events in Q1 2016 and the period thereafter:
    • The US FDA accepted Sanofi's New Drug Application for the lixisenatide/Lantus(r) fixed-ratio combination (type 2 diabetes) for priority review
    • FDA has called for an Advisory Committee meeting on lixisenatide and the lixisenatide/Lantus(r) fixed-ratio combination on 25 May 2016
    • Sanofi filed the lixisenatide/Lantus(r) combination for registration in Europe
    • Zealand advanced two proprietary medicines into Phase II development: ZP4207, a novel glucagon as single-dose formulation for severe hypoglycemia ("insulin shock") in diabetes patients and ZP1848, a novel GLP-2 analogue for short bowel syndrome
    • T he enrolment of 56 diabetes patients has been completed in the single-dose glucagon Phase II trial
    • Helsinn's Phase IIb trial with elsiglutide (chemotherapy-induced diarrhea) missed the primary efficacy endpoint
    • The development of danegaptide for cardiac reperfusion injuries was ceased after the drug candidate showed no effect in a Phase II trial

COPENHAGEN, Denmark, May 18, 2016 (GLOBE NEWSWIRE) -- Zealand Pharma A/S ("Zealand") (CVR no. 20 04 50 78) announces financial results for the three month period 1 January - 31 March 2016, which are as expected and in line with the company's full year guidance. Zealand also reports on important regulatory events for its first-invented medicine, lixisenatide to treat type 2 diabetes, which is outlicensed to Sanofi, and on several updates for its pipeline of drug candidates.

In a comment to the report, Britt Meelby Jensen, President and CEO of Zealand , said:

"In the last quarter and thereafter, there have been important regulatory advancements for lixisenatide and in particular for the fixed-ratio combination of lixisenatide and Lantus(r), which was accepted by the US FDA for a priority review and filed for registration in Europe by Sanofi. Subsequently, the FDA called for an Advisory Committee meeting, which is coming up on 25 May, to have a discussion and recommendation on both products prior to US regulatory decisions anticipated in July and August 2016. This means we have some very important months ahead of us."

"In terms of pipeline development, I regret the negative study read-outs for danegaptide and elsiglutide. At the same time, I am very pleased with our progress with key proprietary drug candidates in Phase II; our novel glucagon analogue, ZP4207 for better treatment and management of hypoglycemia in diabetes and our GLP-2 analogue for short bowel syndrome. We have completed the enrolment of patients in our Phase II trial with ZP4207 as single-dose formulation for rescue treatment of diabetes patients with insulin shock and expect results in Q3 this year. Thereafter, we plan to start Phase II development also of our multiple-dose glucagon product intended for use in a dual-hormone artificial pancreas."

Source: Zealand Pharma A/S