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Last €17.73 EUR
Change Today -0.395 / -2.18%
Volume 0.0
As of 3:38 PM 07/27/15 All times are local (Market data is delayed by at least 15 minutes).

zealand pharma a/s (22Z) Snapshot

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zealand pharma a/s (22Z) Details

Zealand Pharma A/S, a biotechnology company, engages in the discovery, design, and development of peptide medicines in Denmark. It offers Lyxumia (Lixisenatide), a once-daily prandial GLP-1 receptor agonist for the treatment of type 2 diabetes. The company is also developing Lantus (LixiLan), which is in Phase III clinical trials for the treatment of type 2 diabetes; Danegaptide that is in Phase II clinical trials to treat cardiac reperfusion injuries; and Elsiglutide, a GLP-2 receptor agonist, which is in Phase IIb clinical trials for the treatment of chemotherapy-induced diarrhea in patients with colorectal cancer. In addition, it is developing ZP4207 that is in Phase I clinical trials to treat hypoglycemia in diabetes; and ZP2929, a dual acting glucagon/GLP-1 peptide receptor agonist, which is in Phase I clinical trials for the treatment of diabetes and/or obesity. The company has license agreements and partnerships with Sanofi S.A., Helsinn Healthcare S.A., Boehringer Ingelheim International GmbH, and Eli Lilly. Zealand Pharma A/S was founded in 1997 and is based in Copenhagen, Denmark.

103 Employees
Last Reported Date: 05/22/15
Founded in 1997

zealand pharma a/s (22Z) Top Compensated Officers

Chief Financial Officer and Senior Vice Presi...
Total Annual Compensation: kr2.1M
Compensation as of Fiscal Year 2014.

zealand pharma a/s (22Z) Key Developments

Zealand Announces Clinical Phase I trial Results of Glucagon Analogue, ZP4207

Zealand announced results from a clinical Phase I trial with a single-dose version of its novel, stable glucagon analogue, ZP4207. ZP4207, invented and wholly-owned by Zealand, is suited for liquid formulation and has in preclinical studies shown promising potential as a more convenient ready-to-use rescue pen for the treatment of severe hypoglycemia. Zealand initiated the ZP4207 single-dose Phase I trial in November 2014 as a two-part study to evaluate safety and tolerability in both healthy volunteers and Type 1 diabetes patients. The enrollment and treatment of 64 healthy volunteers and 20 patients with Type 1 diabetes was completed ahead of schedule. Based on the results from the trial, Zealand will now progress the development of ZP4207 for severe hypoglycemia towards the next clinical phases. The first-in-man Phase I trial comprised two parts: In Part 1, Zealand enrolled 64 healthy volunteers who were treated with single-ascending doses of ZP4207 primarily to evaluate safety and tolerability and secondarily to evaluate various pharmacokinetic and pharmacodynamic measurements compared to a marketed glucagon hypoglycemia rescue treatment. Results showed that ZP4207 was safe and well tolerated across all doses evaluated (0.01 mg to 2.0 mg per subject). Furthermore, blood glucose levels were increased as expected across a broad dose range; In Part 2 of the trial, the same endpoints were evaluated for a selected single dose of ZP4207 in 20 patients with Type 1 diabetes. The patients were challenged with insulin into hypoglycemia before treatment with ZP4207 to get an indication of the efficacy of ZP4207 to release glucose stores and increase blood glucose levels in a cross-over design with a marketed glucagon rescue treatment as direct active comparator. Results showed that ZP4207 was also safe and well tolerated in patients with Type 1 diabetes. In addition, ZP4207 showed the expected effects on raising blood glucose levels after insulin induced hypoglycemia and similar to the effects of marketed glucagon.

Zealand Pharma Amends Articles of Association to Reflect an Increase in Share Capital After Exercise of Employee Warrants

Zealand Pharma announced an amendment to its articles of association to reflect an increase in the company's share capital following exercise of employee warrants as announced on 20 June 2015. The share capital has been increased by nominal DKK 46,521 to nominal DKK 23,518,108 divided into 23,518,108 shares with a nominal value of DKK 1 each. The amendment of Zealand's Articles of Association entailed by the share capital increase has been registered with the Danish Business Authority.

Zealand Announces Results from GetGoal Duo-2, Showing Advantages of Lyxumia(R) Versus Rapid-Acting Insulin as Add-On to Lantus(R) for the Treatment of Type 2 Diabetes

Zealand Pharma A/S announced that Sanofi reported results from a clinical Phase IIIb trial, GetGoal Duo-2, with Lyxumia(r) (lixisenatide). GetGoal Duo-2 has evaluated the efficacy and safety of once-daily lixisenatide as an add-on to basal insulin for the treatment of Type 2 diabetes patients poorly controlled on basal insulin, versus the addition of rapid acting insulin once daily at main meal (basal-plus) or three times daily at meal-times (basal-bolus). In the trial, lixisenatide was shown to be non-inferior to both comparator insulin regimens for reduction in blood sugar (HbA1c), and statistically superior to the basal-bolus regimen for body weight change, as co-primary endpoints. Further results from the study showed that in the lixisenatide group of patients, documented hypoglycemia was numerically lower than in the group receiving rapid insulin once daily and significantly lower than in the group receiving rapid insulin three times daily. Sanofi has informed that following the presentation of results at ADA, data from GetGoal Duo-2 will be shared with health authorities worldwide and be included also in the regulatory application for lixisenatide in the US, which is on track for re-submission in the third quarter of 2015. Analysis of results from GetGoal-Duo II: the 26-week, randomized, open-label study compared the addition of once-daily lixisenatide (20 ug) to optimally titrated insulin glargine with/without metformin versus the addition of one daily injection (basal-plus) or three daily injections (basal-bolus) of insulin glulisine with or without metformin. The study included 894 patients with Type 2 diabetes, who were predominantly obese and who had been poorly controlled on basal insulin +/- oral anti-diabetics (OADs) for at least 6 months prior to the study. Lixisenatide was shown to be non-inferior to both comparator insulin regimens for reduction in blood sugar (HbA1c) (LS mean difference [95% CI]: -0.05% [-0.17 to 0.06] vs. basal-plus; 0.21% [0.10 to 0.33] vs. basal-bolus; mITT n=890), and superior to basal-bolus for body weight change (LS mean difference [95% CI]: -2.0kg [-2.6 to -1.4kg], p<0.0001 vs. basal-bolus). In addition, post-prandial glucose (PPG) was measured in patients treated before breakfast, and was significantly reduced with lixisenatide compared with both insulin glulisine regimens (LS mean difference [95% CI]: -37mg/dL [-59 to -15mg/dL] vs. basal-plus; -40md/dL [-61 to -19mg/dL] vs. basal-bolus). Documented hypoglycemia was numerically and statistically lower with lixisenatide than with basal-plus and basal-bolus, respectively (estimated rate ratio [95% CI]: 0.8 [0.5 to 1.1], p=0.123 vs. basal-plus; 0.5 [0.3 to 0.7], p<0.0001 vs. basal-bolus; safety n=894). Nausea events were higher with lixisenatide (25% of patients receiving lixisenatide experienced one or more nausea event, 2% of patients on basal-plus regimen, and 1% of patients on basal-bolus).Patients receiving lixisenatide also reported vomiting (9%) and diarrhea (7%).


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