Zealand is ready to take next steps in a diligent growth strategy for accelerated value creation: From peptide to patient

  • Zealand management yesterday presented the strategic direction for Zealand at a Capital Markets Day in New York
  • Building on a strong trajectory, the company will focus to progress select proprietary specialist medicines through to registration, retaining full ownership and value control
  • Pipeline expansion will continuously leverage Zealand's leading-edge peptide expertise, combined with external innovation of new medicines
  • Strong news flow from partnered and proprietary programs expected to continue through 2016

COPENHAGEN, Denmark, Nov. 4, 2015 (GLOBE NEWSWIRE) -- At a Capital Markets Day hosted by Zealand in New York yesterday, Britt Meelby Jensen, President and CEO, gave an update on the status of Zealand's maturing business and presented the strategic direction for the company, under the headline "From peptide to patient".

Zealand is committed to a diligent growth strategy of accelerated value creation for patients and shareholders taking point of departure in four focus areas:

  1. Advance and build the proprietary pipeline: Focus on select proprietary medicines, which Zealand intends to take through to registration, leveraging expected revenue growth from out-licensed portfolio in the years to come.
  2. Focus on specialty diseases: Zealand will pursue therapeutic opportunities in specialty disease areas where peptides have high relevance.
  3. Build on both internal and external innovation, maintaining a dynamic and efficacious R&D structure: Pipeline expansion to building on the company's validated leading-edge scientific expertise in converting peptides into medicines, combined with external innovation.
  4. Leverage via partnerships with a decreasing focus on full out-licensing: Out-license selected assets, while expanding strategic partnerships from early research to commercialization.

The strategy sets the direction for Zealand's business, which combine the following:

  • The first in-house invented medicine, lixisenatide (Lyxumia(r)) for patients with Type 2 diabetes, is marketed globally outside the US and filed for registration in the US, both by Sanofi.
  • A mature pipeline of other products advancing under license collaborations, where all costs are covered outside Zealand:
    LixiLan (Type 2 diabetes) in preparation for regulatory submissions by Sanofi, elsiglutide (chemotherapy induced diarrhea) in Phase IIb development with Helsinn and two pre-clinical collaborations with Boehringer Ingelheim.
  • A growing pipeline of five proprietary medicines in clinical development:
    Danegaptide (cardiac reperfusion injuries) and ZP1848 (Short Bowel Syndrome) in Phase II, ZP4207, both as a single-dose rescue pen (severe hypoglycemia) and for multiple-dose use (control of mild to moderate hypoglycemia) in preparation for Phase II and ZP2929 (diabetes/obesity) in Phase I. The pipeline also includes several preclinical projects.
  • A lean and dynamic organization with ~110 employees of which 80% work in R&D,
  • A solid financial basis and outlook for growing royalty revenues.

Expected news flow outlook for the remainder of 2015 and 2016

Q4 2015

LixiLan - Type 2 diabetes:

Planned regulatory submission in the US (by Sanofi)

H1 2016

Lyxumia(r) (Lixisenatide) - Type 2 diabetes:

Quarterly royalty reports and status updates

LixiLan - Type 2 diabetes:

Planned regulatory submission in Europe (by Sanofi)

Presentation of results from LixiLan-O and LixiLan-L at a medical conference

Elsiglutide - Chemotherapy-induced diarrhea:

Completion of Phase II dose-finding trial (by Helsinn)

Danegaptide - Cardiac reperfusion injuries:

Topline results from Phase II Proof-of-Concept trial (591 patients with Acute Myocardial Infarction)

ZP1848 - Short Bowel Syndrome:

Dosing of the first patients in Phase II Proof-of-Concept trial

ZP4207 (rescue pen) - Severe hypoglycemia:

Initiate Phase II clinical development

Boehringer Ingelheim collaboration - Diabetes/Obesity:

Start preclinical development of new once-weekly GGDA lead

H2 2016

Lyxumia(r) (Lixisenatide) - Type 2 diabetes:

Quarterly royalty reports for Q2 and Q3 2016 and status updates

Regulatory decision by the FDA in the US

Elsiglutide - Chemotherapy induced diarrhea:

Results from Phase IIb trial (by Helsinn)

ZP1848 - Short Bowel Syndrome:

Clinical update on the Phase II Proof-of-Concept trial

ZP4207 (rescue pen) - Severe hypoglycemia:

Results from Phase II clinical trial

ZP4207 (multiple-dose use) - Mild to moderate hypoglycemia:

Initiate next stage of clinical development

Slide presentations from the Capital Markets Day and an audio recording of the presentation given by Britt Meelby Jensen will be made available on Zealand's website.

Capital Markets Day at Zealand's offices in Glostrup, Copenhagen on 18 November 2015

On Wednesday 18 November, from 1:30 pm (lunch from 1:00 pm) to 4:30 pm, Zealand will host a Capital Markets Day for institutional investors and analysts in Denmark at the company's offices in Glostrup, Copenhagen. This event will follow a similar agenda to the meeting being held yesterday in New York, including a presentation by Britt Meelby Jensen on Zealand's fundamental business and strategic direction.

To sign up for participation in the Capital Markets Day at Zealand, please contact: Executive Assistant Annette Boring Kjaer on abk@zealandpharma.com.

Financial guidance and Q3 Interim Report

Guidance for 2015 remains unchanged as communicated. Guidance for 2016 will be provided at the time of the 2015 Full Year results.

The report and financial results for Q3 2015 will be released on Thursday 5 November, and management will host a conference call with live audio webcast on the day at 14:00 CET/08:00 EST.

For further information, please contact

Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: bmj@zealandpharma.com

Hanne Leth Hillman, Senior Vice President for Investor Relations & Communications
Tel: +45 50 60 36 89, email: hlh@zealandpharma.com

About Zealand Pharma

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotech company with unique scientific expertise in peptide-based medicines. Zealand has a growing proprietary pipeline of novel specialty drug candidates and a mature portfolio of products and projects under license collaborations with Sanofi, Helsinn Healthcare and Boehringer Ingelheim.

Zealand's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analogue for the treatment of Type 2 diabetes, is marketed globally (ex-US) as Lyxumia(r) by Sanofi and under regulatory review in the US. The license agreement with Sanofi also covers a single-product combination of lixisenatide and insulin glargine (Lantus(r)) which is on track for regulatory submission in the US in Q4 2015 and in Europe in Q1 2016.

The proprietary pipeline includes; danegaptide for ischemic reperfusion Injuries in Phase II development, ZP1848 for Short Bowel Syndrome in Phase II development and the stable glucagon analogue, ZP4207 as a single-dose rescue pen for severe hypoglycemia in preparation for next clinical phase after Phase I, and ZP4207 as multiple-dose use for the control of mild to moderate hypoglycemia in evaluation for the next clinical development step after Phase I, as well as several preclinical peptide therapeutics.

The company is based in Copenhagen (Glostrup), Denmark. For further information about Zealand's business and activities, please visit: www.zealandpharma.com or follow us on Twitter @ZealandPharma

Source: Zealand Pharma A/S