This Day That Year: Zealand Pharma

Shares of Zealand Pharma A/S (ZEAL) are down 31% from their all-time high of $20.37 recorded on September 8, 2017.

It was on this day last year, i.e. on August 9, 2017, that Zealand debuted on the NASDAQ Global Select Market by setting a public offering at $17.87 per American Depositary Share.

Zealand, based in Copenhagen, Denmark, is a biotechnology company focused on developing peptide-based medicines for gastrointestinal, metabolic and other specialty diseases.

The Company has two marketed products and a couple of clinical programs.

The two marketed products are Lyxumia/Adlyxin, a once-daily prandial GLP-1 receptor agonist for the treatment of type 2 diabetes, and Soliqua 100/33, an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes. These two products are commercialized by Sanofi (SNY).

The Company’s lead product candidate is Dasiglucagon, a potential first-in-class stable glucagon analog.

In March of this year, the results from the first of two phase III clinical trial of Dasiglucagon for treatment of severe hypoglycemia were reported. The primary and key secondary objectives in the trial were to evaluate the risk of treatment-induced and treatment-boosted anti-drug antibodies following three repeat doses of Dasiglucagon in patients with type 1 diabetes, both of which were met.

The second and pivotal phase III trial to confirm the clinical efficacy and safety of Dasiglucagon for the rescue treatment of severe hypoglycemia in patients with type 1 diabetes is ongoing, with results expected this quarter (Q3 2018).

The other ongoing and planned clinical trials with Dasiglucagon are:

— A phase IIb study that will test Dasiglucagon in a home-use setting in the iLet, a bionic pancreas system developed by Beta Bionics, is expected to start later this year.

— A phase III trial that will evaluate Dasiglucagon for congenital hyperinsulism will start once the Company gets the go-ahead from the FDA.

The other clinical programs in the pipeline are:

— Glepaglutide, a long-acting GLP-2 analog in development for the treatment of short bowel syndrome, which is expected to enter a pivotal phase III trial in the second half of this year.

Short bowel syndrome, or SBS, is a chronic and debilitating disease wherein the patients’ length of gastrointestinal tract is less than 2 m or roughly 6.5 ft. The length of that in a normal person will be about 8.5 m or roughly 25 ft. About 20,000 to 40,000 people across the U.S. and Europe are affected by SBS, and they have impaired intestinal absorption, diarrhea and metabolic complications.

— Elsiglutide, a novel GLP-2 peptide analogue, and a phase II-ready compound for the treatment of chemotherapy-induced diarrhea.

— GLP-1/GLU1 dual agonist under phase I trial for the treatment of obesity and/or type 2 diabetes.

— Amylin analog, also under phase I trial for the treatment of obesity and/or type 2 diabetes.

Both GLP-1/GLU1 dual agonist and Amylin analog are out licensed to Boehringer Ingelheim. The research, development and commercialization activities are funded by Boehringer Ingelheim, and Zealand is eligible to receive royalties and milestone payments.

Immediate Catalyst:

The Company’s financial results for the first six months of 2018 are scheduled to be released on August 16, 2018.

Net loss for the year 2017 was DKK 272.3 million ($43.9 million) on revenue of DKK 139.8 million ($22.5 million).

ZEAL has traded in a range of $12.01 to $20.37 in the last 1 year. The stock closed Wednesday’s trading at $14.10, down 3.42%.

by RTTNews Staff Writer

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