0001104659-17-053145.txt : 20170822 0001104659-17-053145.hdr.sgml : 20170822 20170822162232 ACCESSION NUMBER: 0001104659-17-053145 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20170822 FILED AS OF DATE: 20170822 DATE AS OF CHANGE: 20170822 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Zealand Pharma A/S CENTRAL INDEX KEY: 0001674988 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: G7 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38178 FILM NUMBER: 171045386 BUSINESS ADDRESS: STREET 1: SMEDELAND 36 STREET 2: 2600 GLOSTRUP CITY: COPENHAGEN STATE: G7 ZIP: 00000 BUSINESS PHONE: 4588773600 MAIL ADDRESS: STREET 1: SMEDELAND 36 STREET 2: 2600 GLOSTRUP CITY: COPENHAGEN STATE: G7 ZIP: 00000 6-K 1 a17-20855_16k.htm 6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 6-K

 


 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

August 22, 2017

 


 

Commission File Number: 001 - 38178

 


 

Zealand Pharma A/S

(Exact Name of Registrant as Specified in Its Charter)

 


 

Smedeland 36
2600 Glostrup (Copenhagen)
Denmark

(Address of principal executive offices)

 


 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F x            Form 40-F o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  o

 

Furnished as Exhibit 99.1 to this Report on Form 6-K is a press release of Zealand Pharma A/S, or the Company, dated August 22, 2017, announcing the initiation of two Phase 1 trials by the Company’s collaboration partner Boehringer Ingelheim International GmbH, the first with a dual glucagon/GLP-1 receptor agonist that has the potential for once-weekly administration for the treatment of obesity and/or type 2 diabetes, and the second with a novel, differentiated, long-acting amylin analog for the treatment of obesity and/or diabetes.

 

 

 



 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

Zealand Pharma A/S

 

 

 

 

By:

/s/ Mats Blom

 

 

 

 

 

 

Name:

Mats Blom

 

 

Title:

Chief Financial Officer

 

Date: August 22, 2017

 

2



 

EXHIBIT INDEX

 

99.1         Press Release dated August 22, 2017

 

3


EX-99.1 2 a17-20855_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Company announcement — No. 39/2017

 

Phase 1 trials for two novel treatments of obesity and/or diabetes initiated by Zealand partner Boehringer Ingelheim

 

·                  Both compounds were invented through Zealand and Boehringer Ingelheim research collaboration

·                  The novel compounds are a dual-acting glucagon/GLP-1 agonist and a long-acting amylin analog

·                  Zealand to receive a EUR 4 million (DKK 30 million) milestone payment related to  initiation of Phase 1 with the long-acting amylin analog

·                  Results are expected in late 2018 on both compounds

 

Copenhagen, August 22, 2017 — Zealand Pharma A/S (“Zealand”) reports that Boehringer Ingelheim has announced the initiation of two Phase 1 trials, the first with a glucagon/GLP-1 agonist that has the potential for once-weekly administration for the treatment of obesity and/or type 2 diabetes and the second with a novel differentiated long-acting amylin analog for the treatment of obesity and/or diabetes.

 

GLP-1/glucagon dual-acting agonist

 

The dual-acting glucagon/GLP-1 agonist activates both the GLP-1 and glucagon receptors, two key gut hormone receptors and may offer better blood sugar and weight loss control than currently available single agonist treatments. The compound builds partly on the effects of the natural gut hormone oxyntomodulin, which has been shown to decrease food intake and increase energy expenditure in humans.

 

The clinical development of this dual glucagon/GLP-1 agonist will start with a randomized, double-blind, first-in-human study to evaluate the safety and tolerability of single ascending doses in healthy subjects. The study will be conducted in Germany (EudraCT Number: 2017-000295-29; ClinicalTrials.gov Identifier: NCT03175211). Results are expected in late 2018.

 

Long-acting amylin analog

 

Amylin is a pancreatic peptide hormone that plays an important role in decreasing food intake and in the regulation of postprandial plasma glucose levels. The compound is a long-acting analog of amylin and it has demonstrated significant weight loss in preclinical models of obesity.

 

The Phase 1 trial is a randomized, double-blind, first-in-human study to evaluate the safety and tolerability of single ascending doses in healthy subjects. The study will be conducted in Germany (EudraCT Number: 2016-003224-24; ClinicalTrials.gov Identifier: NCT03195088) and funded by Boehringer Ingelheim, with results expected in late 2018.

 

The global prevalence of obesity has more than doubled since 1980. In 2014, more than 1.9 billion adults were classified as overweight and over 600 million of these were obese.(i)

 

Adam Steensberg, Executive Vice President, Chief Medical and Development Officer of Zealand, comments: “We are proud that Boehringer Ingelheim has chosen to move these two novel analogs forward to Phase 1. It demonstrates the quality of Zealand’s approach in developing novel peptides for the potential benefit of millions of people needing adequate solutions for treating obesity and better treatment options for their diabetes. We have a strong partnership with Boehringer Ingelheim and look forward to future studies that will establish if the impressive preclinical weight loss results can be confirmed in clinical trials.”

 



 

Zealand has two collaborations with Boehringer Ingelheim, and under the terms of the two agreements Boehringer Ingelheim funds all research, development and commercialization activities. Zealand is eligible to receive royalties and milestone payments as follows:

 

Long-acting amylin analog (2014 agreement)

 

·                  Initiation of Phase 1 trial triggers a milestone payment of EUR 4 million to Zealand

·                  EUR 283 million outstanding in milestone payments

·                  Mid single-digit to low double-digit percentage royalties on global sales

 

GLP-1/glucagon dual-acting agonist (2011 agreement)

 

·                  EUR 365 million outstanding in milestone payments

·                  High single-digit to low double-digit percentage royalties on global sales

 

For further information, please contact:

 

Britt Meelby Jensen, President and CEO
 Tel.: +45 51 67 61 28, e-mail: bmj@zealandpharma.com

 

Mats Blom, Executive Vice President, Chief Financial Officer

Tel.: +45 31 53 79 73, e-mail: mabl@zealandpharma.com

 

About Zealand Pharma A/S

 

Zealand (Nasdaq Copenhagen and New York: ZEAL) is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines.

Zealand is based in Copenhagen (Glostrup), Denmark.

 

Safe Harbor/Forward-Looking Statements

The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, clinical development activities and anticipated results, product approvals and financial performance. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of clinical trials and other development activities, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Zealand’s products, introduction of competing products, Zealand’s ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.

 

Certain assumptions made by Zealand are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with a product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the United States, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Zealand, promotion of unapproved uses is strictly prohibited.

 


(i)  http://www.who.int/mediacentre/factsheets/fs311/en/

 

2


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