Zealand Pharma A/S was founded in 1997 and is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. We intend to be a leader in specialty medicines focusing on metabolic and gastrointestinal diseases and other specialty disease areas with significant unmet medical needs.. Zealand has a portfolio of medicines and product candidates under license collaborations with Sanofi and Boehringer Ingelheim.
Our pipeline focusing on gastrointestinal, metabolic and other specialty diseases where we believe that the present standard of care is inadequate and where we have the resources to advance our peptide-based product candidates into the later stages of clinical development, including registration and, potentially, commercialization, while opportunistically considering partnership relationships that may arise.
In addition, we are looking to focus our efforts on drug candidates that may qualify for orphan / rare disease status. Our research and development, or R&D, organization is structured to enable dynamic collaboration across various functions and project teams at each stage of discovery and development, allowing us to advance promising opportunities quickly and take advantage of our extensive knowledge of peptide design and product development.
We have a track record of successfully inventing and developing novel peptide-based product candidates. This success is based on our deep understanding of peptide chemistry and extensive experience in improving the therapeutic characteristics of naturally-occurring peptides by modifying and optimizing their structures. The modifications we make are designed to improve upon naturally occurring peptides so that their therapeutic benefit, duration of action, stability and/or convenience of use favorably compare to other treatment options.
Adlyxin® / Lyxumia®
Our portfolio of approved medicines includes lixisenatide, which we have licensed to Sanofi. Lixisenatide is our first out-licensed product approved by both the FDA and the EMA. It is marketed by Sanofi for the treatment of adults with type 2 diabetes in 45 countries outside the United States under the brand name Lyxumia®, and in the United States under the brand name Adlyxin®.
Type 2 diabetes is a disorder that is characterized by high blood glucose, or sugar, and caused by the insufficient production of insulin and/or an inability of the body to adequately respond to insulin. Adlyxin® / Lyxumia® is a once-daily glucagon-like peptide-1, or GLP-1, analog that we invented. It is a synthetic form of the naturally occurring GLP-1 found in the intestines that acts as a signaling hormone, stimulating the pancreas to produce more insulin.
Adlyxin® / Lyxumia® has been observed in clinical trials to lower levels of hemoglobin A1c, or HbA1c (a measure of the three-month average blood glucose level), with a particular effect on meal-related, or prandial, glucose. Lyxumia, was first approved in Europe in 2013 to improve glycemic, or glucose level, control in adult type 2 diabetes patients and has now been approved in 61 countries.
Adlyxin® received FDA approval on July 27, 2016 and Sanofi is currently marketing Adlyxin® in the United States. Lyxumia® is approved outside the United States for use in combination with oral glucose-lowering diabetes medicines or basal, or long-acting, insulin when these treatments, together with diet and exercise, do not provide adequate glycemic control. Adlyxin® is approved in the United States as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Soliqua™ 100/33 / Suliqua
Sanofi has also developed a combination of lixisenatide and Lantus which received approval from the FDA on November 21, 2016 and from the EMA on January 17, 2017. One of these combinations is currently marketed in the United States by Sanofi under the brand name Soliqua100/33 and the other and the other has been launched in the Netherlands and the United Kingdom under the brand name Suliqua. Suliqua is expected to be launched in certain other individual European countries beginning in the second half of 2017. Soliqua100/33 is marketed in a single pre-filled SoloSTAR pen for once-daily dosing covering 15 to 60 units of insulin glargine 100 units/mL and 5 to 20 mcg of lixisenatide. Suliqua is marketed in two pre-filled SoloSTAR pens providing different dosing options: a 10-40 SoloSTAR pre-filled pen will deliver 10 to 40 dose steps of insulin glargine 100 units/mL in combination with 5 to 20 mcg of lixisenatide, whereas a 30-60 SoloSTAR pre-filled pen will deliver 30 to 60 units of insulin glargine 100 units/mL in combination with 10 to 20 micrograms of lixisenatide. SoloSTAR is the most frequently used disposable insulin injection pen platform in the world.
Soliqua™ 100/33 / Suliqua is one of the first combinations of a GLP-1 analog and basal insulin to treat type 2 diabetes to be approved for marketing and launched for sale in the United States and is one of only two products (the other being Novo Nordisk’s Xultophy, which is a combination of its GLP-1 analog Victoza and basal insulin Tresiba) in this new product class. Soliqua100/33 is approved in the United States as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide alone. Suliqua is authorized in Europe for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.
Soliqua™ 100/33 / Suliqua has been observed in clinical trials to result in benefits, as compared to treatments with either basal insulin or a GLP-1 analog alone, pointing towards what we believe to be a potentially significant commercial opportunity.
Our internal pipeline includes three product candidates in clinical development: glepaglutide, which is being developed to treat short bowel syndrome, or SBS; dasiglucagon, formulated for use in a single-dose, ready-to-use disposable injection pen, which is being developed as a rescue treatment for severe hypoglycemia or ‘‘insulin shock’’; and dasiglucagon, formulated for use in multiple-dose administrations, which is being developed for use in new treatment concepts for insulin-dependent diabetes patients, such as a dual-hormone artificial pancreas system for improved hypoglycemia control and better diabetes management and a single hormone pump for the treatment of congenital hyperinsulinism, or CHI.
Licensed product candidates
We have also out licensed product candidates to Boehringer Ingelheim International GmbH, or BI. We have out licensed two peptide programs to BI that have been advanced into preclinical development: a once-weekly novel dual glucagon/GLP-1 receptor agonist product candidate for the treatment of diabetes and/or obesity and a novel long-acting amylin analog for the treatment of obesity and diabetes. The lead product candidates for each collaboration were selected in February 2016 and October 2015, respectively.
In the second half of 2016, BI confirmed its intention to bring both product candidates into Phase 1 clinical testing in the third quarter of 2017.
Zealand in brief
• Glepaglutide* for short bowel syndrome (SBS)
• Dasiglucagon* for acute, severe hypoglycemia
• Dasiglucagon* for type 1 diabetes care
• Dasiglucagon for congenital hyperinsulinemia
• A dual GLP1-GLU for obesity/type 2 diabetes
• Amylin analog for obesity/type 2 diabetes
Scientific focus and platform
We invent and develop medicines focusing on specialty metabolic and gastrointestinal diseases.
Zealand has since 1998 been discovering and optimizing peptide therapeutics as novel drugs.