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News Article | December 8, 2016
Site: globenewswire.com

Zealand increases its share capital as a consequence of exercise of employee warrants Copenhagen, 8 December 2016 - Zealand Pharma ("Zealand") has increased its share capital with nominal DKK 13,999 divided into 13,999 new shares with a nominal value of DKK 1 each. The increase is a consequence of the exercise of warrants granted under one of Zealand's employee warrant programs. Employee warrant programs are part of Zealand's incentive scheme, and each warrant gives the owner the right to subscribe for one new Zealand share at a pre-specified price, the exercise price, in specific pre-defined time periods before expiration. For further description of Zealand's warrant programs, see the company's Articles of Association, which are available on the homepage: www.zealandpharma.com. The exercise price is DKK 77 and the total proceeds to Zealand from the capital increase amounts to DKK 1,077,923. The new shares give rights to dividend and other rights from the time of the warrant holder's exercise notice. Each new share carries one vote at Zealand's general meetings. Zealand only has one class of shares. The new shares will be listed on Nasdaq Copenhagen after registration of the capital increase with the Danish Business Authority. Following registration of the new shares, the share capital of Zealand will be nominal DKK 26,142,365 divided into 26,142,365 shares with a nominal value of DKK 1 each. The amendment of Zealand's Articles of Association entailed by the share capital increase has today been registered with the Danish Business Authority. Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under licence collaborations with Sanofi, Boehringer Ingelheim and Helsinn, and a pipeline of proprietary product candidates which primarily target specialty diseases with significant unmet needs. The company's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analogue for the treatment of type 2 diabetes, is licensed to Sanofi. Lixisenatide is marketed as Lyxumia® outside the United States and approved as Adlyxin(TM) in the United States. Lixisenatide has been developed in a fixed-ratio combination with basal insulin glargine (Lantus®) and is approved as Soliqua(TM) 100/33 in the United States, and in Europe a CHMP positive opinion recommendation was given in November (Suliqua(TM) is the brand name in Europe). Zealand's proprietary pipeline includes: Dasiglucagon* (ZP4207) (single-dose rescue treatment) for acute, severe hypoglycaemia (Phase II); Glepaglutide* (ZP1848) for short bowel syndrome (Phase II); Dasiglucagon* (ZP4207) (multiple-dose version) intended for use in a dual-hormone artificial pancreas system for better hypoglycaemia control and diabetes management (in preparation for Phase II); and other earlier stage clinical and preclinical peptide therapeutics. Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the company's business and activities, please visit www.zealandpharma.com or follow Zealand on Twitter @ZealandPharma. * Dasiglucagon and Glepaglutide are proposed International Nonproprietary Names (pINN).


News Article | November 9, 2016
Site: globenewswire.com

Copenhagen, 9 November 2016 - Zealand Pharma A/S ("Zealand") (CVR no. 20 04 50 78) today reported financial results for the period, 1 January - 30 September 2016. The financial guidance on revenue for 2016 remains unchanged while the guidance on net operating expenses has been reduced. Financial results for the first nine months of 2016 Britt Meelby Jensen, President and CEO of Zealand, commented on the report: "During the third quarter, we continued to advance our own clinical programs, with solid progress in patient recruitment for the glepaglutide Phase II trial and notably dasiglucagon with positive Phase II results for rescue treatment of acute severe hypoglycemia. In terms of our partnered programs, we are excited to have the first ever Zealand invented product approved in the U.S, the GLP-1 receptor agonist lixisenatide under the brand name AdlyxinTM. The FDA decision on iGlarLixi, the fixed-dose combination product with basal insulin, was extended by three months, from August to November, so we are close to reach this important milestone." Royalty revenue on Sanofi's sales of Lyxumia® amounted to DKK 19.0 million / €2.6 million in the first nine months of 2016. Lyxumia® is approved in more than 60 countries and has been launched by Sanofi in 45 of these. In July 2016, lixisenatide was approved by FDA under the brand name Adlyxin(TM) which triggered a DKK 33.5 million / $5 million milestone payment from Sanofi. On 19 August 2016, the U.S. FDA extended the PDUFA goal date for Sanofi's New Drug Application (NDA) for iGlarLixi by three months. A U.S. regulatory decision on iGlarLixi is now expected before the end of November 2016. iGlarLixi is also undergoing review by the European Medicines Agency (EMA) with a regulatory decision for Europe expected in Q1 2017. Zealand has two preclinical peptide programs under license collaborations with Boehringer Ingelheim. One covers glucagon/GLP-1 dual agonists for the treatment of diabetes and/or obesity, and the other covers novel compounds against an undisclosed biological target for the treatment of obesity and/or diabetes. Under both collaborations a lead candidate is being progressed towards start of clinical Phase I development in 2017. Results reported from a Phase IIb trial in May 2016 showed that elsiglutide reduced chemotherapy-induced diarrhea (CID) in colorectal cancer patients, however not sufficiently to meet the primary efficacy endpoint for the trial. After evaluating the Phase IIb results, Helsinn has informed Zealand that in 2017 they will initiate one or more exploratory clinical trials in alternative patient settings with a higher incidence of CID, which, if successful, could lead to further development of elsiglutide. The ongoing Phase II Proof-of-Concept trial continues to progress according to plan, with results expected mid-2017. In August 2016, Zealand announced positive results from a clinical Phase II trial with dasiglucagon, supporting its potential as a ready-to-use rescue pen to treat acute, severe hypoglycemia ("insulin shock") associated with insulin therapy in diabetes. Zealand is in preparation for submission of the data to FDA with the aim of entering the next development steps in 2017. In June 2016, a non-exclusive collaboration was announced with U.S. based Beta Bionics. The objective is to advance the development of a first-in-class dual-hormone artificial pancreas system to offer diabetes patients on insulin therapy, an easier and better way to control and manage their disease. Later in 2016, Zealand plans to initiate a clinical trial with Beta Bionics and is also planning a PK/PD trial for multiple dose dasiglucagon. Zealand has decided to pause development activities on ZP2929 and does not plan to continue development of this product candidate without a partner. This decision will enable Zealand's development organisation to fully focus on the three mid-to-late phase development programs, glepaglutide and the two dasiglucagon programs, in line with Zealand's strategy. Revised financial guidance for 2016 Zealand maintains its revenue guidance for the full-year of revenues of up to DKK 200 million in the form of milestone payments from partners and a growing royalty revenue from Sanofi's sales assuming a launch of AdlyxinTM in the U.S. late 2016. Net operating expenses in 2016 are expected at a range of DKK 320-330 million, 6-8% lower than previously forecasted, and operating loss before royalty income/expenses is therefore expected at a range of DKK 120-130 million. The decrease in expected net operating expenses relates to clinical studies as well as a tight cost control. Conference call on Wednesday, 9 November 2016 at 2 pm CET / 8 am EDT On the day of release, Zealand's senior management will host a conference call at 2 pm CET to present the interim report for the first nine months of 2016. Participating in the call will be Britt Meelby Jensen, President and Chief Executive Officer, Mats Blom, SVP and Chief Financial Officer and Adam Steensberg, SVP and Chief Medical and Development Officer. The presentation will be followed by a Q&A session. The conference call will be conducted in English and the dial-in numbers are: Kindly inform the operator of the following passcode: "Zealand Pharma" or 9968202. A live audio webcast of the call including an accompanying slide presentation will be available via the following link, http://edge.media-server.com/m/p/spwqjphn accessible also from the company's website (www.zealandpharma.com). Participants are advised to register for the webcast approximately 10 minutes before the start. A replay of the event will be made available from the Investor section of Zealand's website following the call. For further information, please contact: Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under license collaborations with Sanofi, Boehringer Ingelheim and Helsinn and a pipeline of proprietary product candidates, which primarily target specialty diseases with significant unmet needs. The company's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analog for the treatment of type 2 diabetes, is licensed to Sanofi. Lixisenatide is marketed as Lyxumia® outside the United States and approved as AdlyxinTM in the United States. Lixisenatide has been developed in a fixed-ratio combination with Lantus® (insulin glargine) which product is under regulatory review in the United States and in Europe. Zealand's proprietary pipeline includes: Dasiglucagon* (ZP4207) as single-dose rescue treatment for acute, severe hypoglycemia (Phase II); Glepaglutide* (ZP1848) for treatment of short bowel syndrome (Phase II); Dasiglucagon* (ZP4207) multiple-dose version intended for use in a dual-hormone artificial pancreas system for better hypoglycemia control and diabetes management (in preparation for Phase II); and other earlier stage clinical and preclinical peptide therapeutics. Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the company's business and activities, please visit www.zealandpharma.com or follow Zealand on Twitter @ZealandPharma. * Dasiglucagon and glepaglutide are proposed International Nonproprietary Names (pINN)


Zealand Pharma (Zealand) today announced that it has dosed the first patients in its Phase IIa clinical trial with dasiglucagon[1] in a dual-hormone artificial (or bionic) pancreas system from Beta Bionics. Dasiglucagon is a Zealand-invented glucagon analogue with a unique stability profile in liquid formulation. The multiple-dose version of dasiglucagon is intended for use in a dual-hormone artificial pancreas system to better control hypoglycaemia and, potentially, hereby provide insulin treated diabetes patients with options for easier and more effective management of their disease. The Phase IIa trial is the fourth Phase II trial initiated by Zealand this year, demonstrating the significant progress in Zealand's pipeline of proprietary product candidates. People with type 1 diabetes depends on a complex daily insulin regimen to control their blood glucose. They must regularly track and adjust their blood sugar levels to reduce the acute and chronic risks associated with hypo- and hyperglycaemia. A dual-hormone artificial (or bionic) pancreas system, which automatically delivers insulin and glucagon, aims to mimic the function of a healthy pancreas[2]. Steven J. Russell, MD, Massachusetts General Hospital Diabetes Center in Boston, MA, USA, and Principal Investigator: "Our previous studies have shown that a dual-hormonal bionic pancreas can provide very effective management of glycemia in people with type 1 diabetes. All of our previous studies have used glucagon that have very limited stability, so the glucagon pump had to be refilled daily. More importantly, the unstable glucagon formulations will not meet the regulatory requirements to be approved for use in a bionic pancreas. This Phase IIa study will test the effectiveness of the stable glucagon analogue dasiglucagon in the dual-hormone bionic pancreas, comparing it with the unstable glucagon formulation that we have used in all of our previous studies. Demonstrating the effectiveness of a stable glucagon formulation or analogue, such as dasiglucagon, is an essential step towards making a dual-hormone bionic pancreas available to patients." Adam Steensberg, Senior Vice President, Chief Medical & Development Officer, Zealand: "We are happy to have initiated our fourth Phase II trial this year, showing significant progress in our clinical pipeline of medicines that we fully own and develop ourselves. This is the first trial evaluating Zealand's glucagon analogue, dasiglucagon, in the clinic for use in the dual-hormone artificial pancreas, under development by Beta Bionics and Boston University. Such a system has the ultimate potential to offer people with diabetes on insulin therapy more efficacious, safer and easier blood sugar control." Zealand entered into a collaboration with Beta Bionics, a Boston-based company, earlier this year. Beta Bionics is developing a dual-hormone artificial (bionic) pancreas system based on advanced technology that was conceived and refined at Boston University and has been undergoing clinical trials for nearly 10 years at the Massachusetts General Hospital and, more recently, Stanford University, the University of North Carolina and the University of Massachusetts. The technology is being integrated at Beta Bionics into a pocket-sized wearable medical device called the iLetTM. The Phase IIa trials The aim of the Phase IIa clinical trial with Beta Bionics is to assess, for the first time, the safety, efficacy and tolerability of dasiglucagon as part of the Beta Bionics dual-hormone artificial (bionic) pancreas system in adult patients with type 1 diabetes, compared to a recombinant market glucagon. In collaboration with Beta Bionics and Boston University, the trial is conducted at the Massachusetts General Hospital Diabetes Research Center in Boston, MA, USA, with MD Steven J. Russell as Principal Investigator. Earlier this month, Zealand initiated another Phase IIa trial with the aim of assessing PK and PD responses after administration of the multiple-dose version of dasiglucagon in adult patients with type 1 diabetes. The first patients have been dosed. The Phase IIa trials are designed to provide the foundation for longer clinical trials with the multiple-dose version of dasiglucagon in the dual-hormone artificial pancreas system. Results from both trials are expected in H1 2017. For further information on the Phase IIa trials, see: ClinicalTrials.gov Identifier: NCT02916251 ClinicalTrials.gov Identifier: NCT02971228 For further information, please contact Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under licence collaborations with Sanofi, Boehringer Ingelheim and Helsinn, and a pipeline of proprietary product candidates that primarily target specialty diseases with significant unmet needs. The company's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analogue for the treatment of type 2 diabetes, is licensed to Sanofi. Lixisenatide is marketed as Lyxumia® outside the United States and approved as Adlyxin(TM) in the United States. Lixisenatide has been developed in a fixed-ratio combination with basal insulin glargine (Lantus®) and is approved as Soliqua(TM) 100/33 in the United States, and in Europe a CHMP positive opinion recommendation was given in November (Suliqua(TM) is the brand name in Europe). Zealand's proprietary pipeline includes: dasiglucagon* (ZP4207) (single-dose rescue treatment) for acute, severe hypoglycaemia (phase II); glepaglutide* (ZP1848) for short bowel syndrome (phase II); dasiglucagon* (ZP4207) (multiple-dose version) intended for use in a dual-hormone artificial pancreas system for better hypoglycaemia control and diabetes management (in phase II); and other earlier-stage clinical and preclinical peptide therapeutics. Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the company's business and activities, please visit www.zealandpharma.com or follow Zealand on Twitter @ZealandPharma. [2] Russel et al. "Outpatient glycemic control with a bionic pancreas in Type 1 diabetes", New England Journal of Medicine (2014)


Aktiekapitalen i Zealand Pharma A/S vil med virkning fra den 12. december 2016 blive forhøjet på Nasdaq Copenhagen. Optagelse til handel og officiel notering af nye aktier vil ske i nedenstående ISIN. ISIN: DK0060257814 ------------------------------------------------------- Navn: Zealand Pharma ------------------------------------------------------- Mængde før ændring: 26.128.366 stk. (26.128.366 kr.) -------


The share capital of Zealand Pharma has been increased. The admittance to trading and official listing of new shares will take effect as per 21 November in the ISIN below. For further information, please contact: Asta Jepsen, Surveillance, tel. +45 33 93 33 66


The share capital of Zealand Pharma has been increased. The admittance to trading and official listing of new shares will take effect as per 21 November in the ISIN below. For further information, please contact: Asta Jepsen, Surveillance, tel. +45 33 93 33 66


Zealand informs that its management will present the company and host investor meetings at the following healthcare and biotech investor forums in November and December 2016, taking place in Paris, London and New York, respectively. Zealand will host one-to-one investor meetings. Britt Meelby Jensen, President and CEO and Mats Blom, Senior Vice President and CFO will represent the company. Zealand will host one-to-one meetings. Britt Meelby Jensen, President and CEO and Mats Blom, Senior Vice President and CFO will represent the company. Zealand will host one-to-one investor meetings. Britt Meelby Jensen, President and CEO and Mats Blom, Senior Vice President and CFO will represent the company. Please note that no new financial or other material information relating to Zealand and its business will be disclosed at these meetings. For further information, please contact: Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under license collaborations with Sanofi, Boehringer Ingelheim and Helsinn and a pipeline of proprietary product candidates, which primarily target specialty diseases with significant unmet needs. The company's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analog for the treatment of type 2 diabetes, is licensed to Sanofi. Lixisenatide is marketed as Lyxumia® outside the United States and approved as AdlyxinTM in the United States. Lixisenatide has been developed in a fixed-ratio combination with Lantus® (insulin glargine) which product is under regulatory review in the United States and in Europe. Zealand's proprietary pipeline includes: Dasiglucagon* (ZP4207) as single-dose rescue treatment for acute, severe hypoglycemia (Phase II); Glepaglutide* (ZP1848) for treatment of short bowel syndrome (Phase II); Dasiglucagon* (ZP4207) multiple-dose version intended for use in a dual-hormone artificial pancreas system for better hypoglycemia control and diabetes management (in preparation for Phase II); and other earlier stage clinical and preclinical peptide therapeutics. Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the company's business and activities, please visit www.zealandpharma.com or follow Zealand on Twitter @ZealandPharma. * Dasiglucagon and glepaglutide are proposed International Nonproprietary Names (pINN)


News Article | November 30, 2016
Site: globenewswire.com

Total number of shares and voting rights in Zealand as of 30 November 2016 Copenhagen, 30 November 2016 - In accordance with Section 6 of the Danish Statutory Order on Issuers' Disclosure Obligations, Zealand issues announcements to state the total number of shares and voting rights in the company at the end of a calendar month in which there have been changes to its share capital. In company announcement no. 45 / 2016 on 17 November 2016 and company announcement no. 47 / 2016 on 25 November 2016, Zealand announced increases in its share capital after exercise of employee warrants. Following these announcements, the table below lists the total number of shares and voting rights in Zealand as of 30 November 2016: For further information, please contact: Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under licence collaborations with Sanofi, Boehringer Ingelheim and Helsinn, and a pipeline of proprietary product candidates which primarily target specialty diseases with significant unmet needs. The company's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analogue for the treatment of type 2 diabetes, is licensed to Sanofi. Lixisenatide is marketed as Lyxumia® outside the United States and approved as Adlyxin(TM) in the United States. Lixisenatide has been developed in a fixed-ratio combination with basal insulin glargine (Lantus®) and is approved as Soliqua(TM) in the United States, and in Europe a CHMP positive opinion recommendation was given on 11 November. Suliqua(TM) is the brand name in Europe. Zealand's proprietary pipeline includes: Dasiglucagon* (ZP4207) (single-dose rescue treatment) for acute, severe hypoglycaemia (Phase II); Glepaglutide* (ZP1848) for short bowel syndrome (Phase II); Dasiglucagon* (ZP4207) (multiple-dose version) intended for use in a dual-hormone artificial pancreas system for better hypoglycaemia control and diabetes management (in preparation for Phase II); and other earlier stage clinical and preclinical peptide therapeutics. Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the company's business and activities, please visit www.zealandpharma.com or follow Zealand on Twitter @ZealandPharma. * Dasiglucagon and Glepaglutide are proposed International Nonproprietary Names (pINN).


News Article | October 28, 2016
Site: globenewswire.com

Lyxumia® (lixisenatide) royalty revenue of DKK 6 million / € 0.8 million in Q3 2016 from Sanofi's sales outside the U.S. Copenhagen, 28 October 2016 - Zealand Pharma (Zealand), reports royalty revenue from Sanofi's global sales of lixisenatide (marketed as Lyxumia® outside the U.S.) of DKK 6.1 million / € 0.8 million for the period from 1 July to 30 September 2016. For the first nine months of 2016, Zealand's royalty revenue amounted to DKK 19.0 million / € 2.6 million. Lixisenatide is a once-daily prandial GLP-1 receptor agonist for the treatment of patients with type 2 diabetes and was invented by Zealand, with global development and commercialization rights licensed to Sanofi. Lixisenatide is marketed under the brand name Lyxumia® in over 45 countries and was approved in the U.S. under the brand name AdlyxinTM in July 2016. Sanofi has also developed iGlarLixi, a fixed-ratio combination of lixisenatide and insulin glargine 100 units/mL (Lantus®), which is under regulatory review in both the U.S. and Europe. A regulatory decision is expected in November 2016 in the U.S. and in Q1 2017 in Europe. For further information, please contact: Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under license collaborations with Sanofi, Boehringer Ingelheim and Helsinn and a pipeline of proprietary product candidates, which primarily target specialty diseases with significant unmet needs. The company's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analog for the treatment of type 2 diabetes, is licensed to Sanofi. Lixisenatide is marketed as Lyxumia® outside the United States and approved as AdlyxinTM in the United States. Lixisenatide has been developed in a fixed-ratio combination with Lantus® (insulin glargine) which product is under regulatory review in the United States and in Europe. Zealand's proprietary pipeline includes: Dasiglucagon* (ZP4207) as single-dose rescue treatment for acute, severe hypoglycemia (Phase II); Glepaglutide* (ZP1848) for treatment of short bowel syndrome (Phase II); Dasiglucagon* (ZP4207) multiple-dose version intended for use in a dual-hormone artificial pancreas system for better hypoglycemia control and diabetes management (in preparation for Phase II); and other earlier stage clinical and preclinical peptide therapeutics. Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the company's business and activities, please visit www.zealandpharma.com or follow Zealand on Twitter @ZealandPharma. * Dasiglucagon and glepaglutide are proposed International Nonproprietary Names (pINN)


Zealand Pharma (Zealand) har i dag meddelt, at virksomheden har doseret de første patienter i et fase IIa-forsøg med dasiglucagon[1] i et kunstigt bi-hormonelt bugspytkirtelsystem fra Beta Bionics. Dasiglucagon er en glukagonanalog, opfundet af Zealand, med en unik stabilitetsprofil til brug i flydende formulering. Dasiglucagon som flergangsdosering er beregnet til brug i et kunstigt bi-hormonelt bugspytkirtelsystem med henblik på at opnå bedre kontrol af hypoglykæmi og dermed potentielt give diabetespatienter, der får insulin, bedre muligheder for en lettere og samlet set mere effektiv sygdomsbehandling. Mennesker med type 1-diabetes er afhængige af et kompliceret dagligt insulin regime for at kontrollere deres blodsukker. De skal regelmæssigt måle og justere blodsukkerniveauet for at mindske de akutte og kroniske risici, der er forbundet med hypo- og hyperglykæmi. Et kunstigt bi-hormonelt bugspytkirtelsystem, der automatisk leverer insulin og glukagon, har til formål at efterligne funktionen af den raske bugspytkirtel[2]. Steven J. Russell, MD, Massachusetts General Hospital Diabetes Center i Boston, Massachusetts, USA, og ledende investigator: "Vores tidligere forsøg har vist at den kunstige bi-hormonelle bugspytkirtel kan medvirke til en meget effektiv styring af blodsukkeret i personer med type 1-diabetes. I alle vores tidligere forsøg har vi brugt glukagon med meget begrænset stabilitet, hvilket har betydet at glukagonpumpen skulle genopfyldes dagligt. Vigtigere er, at formuleringerne af den ustabile glukagon ikke vil leve op til de regulatoriske krav for at blive godkendt for brug i en bi-hormonel bugspytkirtel. Dette fase IIa-forsøg vil teste effekten af den stabile glukagon analog, dasiglucagon, i den kunstige bi-hormonelle bugspytkirtel ved at sammenligne den med den ustabile formulering af glukagon, som vi har anvendt i alle vores tidligere studier. At vise effekten af en stabil glukagon formulering eller analog, som dasiglucagon, er et vigtigt skridt mod at gøre den kunstige bi-hormonelle bugspytkirtel tilgængelig for patienter. " Adam Steensberg, direktør for medicinsk udvikling, Zealand: "Vi er glade for at have indledt vores fjerde fase II-forsøg i år. Det understreger det store fremskridt i vores kliniske pipeline af lægemidler, som vi selv udvikler har fuldt ejerskab af. Dette forsøg er det første, der evaluerer Zealands glukagon analog, dasiglucagon, i klinikken til brug i den kunstige bi-hormonelle bugspytkirtel, som er under udvikling af Beta Bionics og Boston University. Et sådant system har ultimativt potentiale til at tilbyde diabetespatienter, der får insulinbehandling, en mere effektiv, sikker og lettere blodsukkerkontrol." Zealand indgik tidligere i år et samarbejde med Beta Bionics, en virksomhed baseret i Boston. Beta Bionics er ved at udvikle et kunstigt bi-hormonelt bugspytkirtelsystem baseret på avanceret teknologi, som er udviklet og videreudviklet på Boston University, og som er blevet testet i kliniske forsøg gennem de sidste 10 år på Massachusetts General Hospital og senest på Stanford University, the University of North Carolina og University of Massachusetts. Teknologien er hos Beta Bionics ved at blive integreret i et transportabelt udstyr i lommestørrelse, der hedder iLetTM. Fase IIa-forsøgene Formålet med fase IIa-forsøget med Beta Bionics er for første gang at vurdere sikkerheden, virkningen og tolerabiliten af dasiglucagon som en del af Beta Bionics kunstige bi-hormonelle bugspytkirtelsystem hos voksne patienter med type 1-diabetes sammenlignet med et rekombinant glukagon, der allerede er på markedet. Forsøget gennemføres på Massachusetts General Hospital Diabetes Center i Boston, Massachusetts, USA, i samarbejde med Beta Bionics og Boston University med Steven J. Russell, MD som ledende investigator. [2] Russel et al. "Outpatient glycemic control with a bionic pancreas in Type 1 diabetes", New England Journal of Medicine (2014)

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