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New data on lixisenatide (Lyxumia(r)) including ELIXA results on LixiLan, and on novel Zealand peptide therapeutics, to be presented at the American Diabetes Association's (ADA) 75th Scientific Sessions

  • Results of the ELIXA cardiovascular safety outcome trial on lixisenatide to be discussed in a key symposium on Monday 8 June, at 2:15pm EDT
  • Additional results from the Phase IIb clinical trial of LixiLan to be presented
  • Zealand will present data on two of its novel preclinical peptide therapeutics; dual acting GLP-1-GIP and GLP-1-gastrin receptor agonists, both representing potential new strategies for the treatment of Type 2 diabetes and obesity

COPENHAGEN, Denmark, June 2, 2015 (GLOBE NEWSWIRE) -- Zealand Pharma A/S ("Zealand") (Nasdaq Copenhagen: ZEAL) informs that new data will be presented on lixisenatide, the company's first own-invented marketed medicine for the treatment of Type 2 diabetes, at the upcoming 75th Scientific Sessions of the American Diabetes Association (ADA) to be held in Boston on 5 - 9 June 2015. Further, at the event, Zealand will present two of its novel preclinical peptide therapeutics with potential for better treatment of diabetes and obesity.

Lixisenatide

Lixisenatide is marketed worldwide ex-US as Lyxumia(r) by Sanofi (SANF.PA) under a global license agreement. Lixisenatide is the first once-daily short-acting GLP-1 receptor agonist with a pronounced effect on prandial (meal-related) glucose and its therapeutic profile will be featured in a total of 13 presentations at ADA. These include important results of the cardiovascular safety outcome trial, ELIXA, to be unveiled in a symposium under the title:

"The Evaluation of Lixisenatide in Acute Coronary Syndrome --The Results of ELIXA",

Monday, June 8, from 2:15 pm to 4:15 pm EDT

In the symposium, the ELIXA executive committee will discuss initial results of the trial in 6,000 patients with Type 2 diabetes who experienced an acute coronary event. The trial compares a once-daily dose of lixisenatide to placebo, with cardiovascular events as the primary endpoint.

Other highlighted presentations on lixisenatide include results from the GetGoal Duo-II Phase IV clinical trial, which examined the efficacy and safety of lixisenatide compared with Apidra(r) (insulin glulisine), when both are added to Lantus(r) (insulin glargine injection, 100U/mL):

"Advancing Basal Insulin Glargine with Prandial Lixisenatide QD vs Insulin Glulisine QD or TID in T2DM: The GetGoal-Duo 2 Evidence-Based Trial" - POSTER 107-LB (Late Breaking), Sunday, 7 June at 12pm EDT.

LixiLan

On LixiLan, the single-injection fixed-ratio combination of lixisenatide and Lantus(r), additional results from the Phase IIb clinical trial (323 patients with Type 2 diabetes) will be presented in an oral session on "Combining Basal Insulin and GLP-1 Agonists" under the title:

"Improved Glucose Control without Increased Hypoglycemia Risk at Any Level of HbA1c Reduction with Insulin Glargine/Lixisenatide Fixed-Ratio Combination (LixiLan) vs. Insulin Glargine Alone Both Added On to Metformin in Type 2 Diabetes (T2DM)" - 169-OR, Sunday, 7 June at 8:45 am EDT.

Zealand preclinical peptide therapeutics

Scientists from Zealand will present the data on two of the company's novel preclinical peptide therapeutics, representing co-activation of GLP-1 and GIP receptors and of GLP-1 and gastrin, respectively, as promising new strategies for improved treatment of Type 2 diabetes and obesity. Results from preclinical models demonstrate promising effects and will be featured in three poster presentations as follows:

"Pharmacokinetics and pharmacodynamics of GLP-1-GIP receptor dual agonist peptides: from once-daily to once-weekly", M. A. Deryabina et al. - 2086-P, category 16-E "Integrated Physiology - Other hormones".

"An optimized novel GLP-1-GIP receptor dual agonist with potent effects on body weight and glucose control in mice has the potential for once-weekly administration in humans", C.B. Knudsen et al. - 2061-P, Category 16-E "Integrated Physiology - Other hormones

"Effect of GLP-1-Gastrin Dual Agonist ZP3022 on Pancreas Gene Expression in ZDF Rats", J. Skarbaliene et al. - 2085-P, category "Integrated Physiology - Other Hormones".

Zealand's presence at ADA highlights the relevance of peptide-based medicines in the treatment of metabolic diseases. Spanning a range of therapy areas, Zealand is building a growing proprietary pipeline of novel medicines based on its expertise in the field of peptide design and synthesis.

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For further information, please contact:

Britt Meelby Jensen, President and Chief Executive Officer

Tel: +45 51 67 61 28, email: bmj@zealandpharma.com

Hanne Leth Hillman, Senior Vice President, Investor Relations & Communications

Tel: +45 50 60 36 89, email: hlh@zealandpharma.com

About Zealand Pharma

Zealand Pharma A/S ("Zealand") (Nasdaq Copenhagen: ZEAL) is a biotechnology company based in Copenhagen, Denmark. Zealand has leading expertise in the discovery, design and development of novel peptide medicines and possesses in-house competences in clinical trial design and management with a therapeutic focus on metabolic diseases and acute care indications. The company is advancing a proprietary pipeline of novel medicines alongside a partnered product and development portfolio.

Zealand's first invented medicine, lixisenatide, a once-daily prandial GLP-1 agonist for the treatment of Type 2 diabetes, is marketed globally (ex-US) as Lyxumia(r) and is in Phase III development as a single-injection combination with Lantus(r) (LixiLan), both under a global license agreement with Sanofi. US regulatory filing for Lyxumia(r) is planned for Q3 2015 and filing for LixiLan is planned for Q4 2015 in the US and Q1 2016 in Europe.

Zealand's proprietary pipeline includes danegaptide (prevention of Ischemic Reperfusion Injury) and two stable glucagon products, ZP4207 (treatment of severe hypoglycemia and of mild to moderate hypoglycemia) as well as several preclinical peptide therapeutics. Partnering represents an important component of strategy to leverage in-house expertise, share development risk in large clinical trials, provide funding and commercialize the company's products. Zealand currently has global license agreements and partnerships with Sanofi, Helsinn Healthcare and Boehringer Ingelheim.

For further information: www.zealandpharma.com Follow us on Twitter @ZealandPharma

Source: Zealand Pharma A/S