Zealand Pharma Announces Global License and Development Agreement with Novo Nordisk for ZEGALOGUE® (dasiglucagon)
07 Setembro 2022 - 3:00AM
Company announcement – No. 38 / 2022
- Agreement includes an upfront payment, development, regulatory,
manufacturing and sales-based milestones of up to DKK 290 million
to Zealand in addition to high-single to low-double digit royalties
on worldwide net sales
- Zealand will be responsible for certain planned development,
regulatory, and manufacturing activities to support approval
outside the U.S.
- Deal marks further execution on Zealand’s strategy to engage in
commercial partnerships and prioritize R&D
Copenhagen, DK and Boston, MA, U.S.
September 7, 2022 – Zealand Pharma A/S
(Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company focused
on the discovery and development of innovative peptide-based
medicines, today announced it has entered into a global license and
development agreement with Novo Nordisk A/S to commercialize
ZEGALOGUE® (dasiglucagon) for injection.
ZEGALOGUE® is approved by the U.S. Food and Drug Administration
(FDA) for the treatment of severe hypoglycemia in pediatric and
adult patients with diabetes aged 6 and above.
Under the terms of the agreement, Zealand will receive an
upfront payment of DKK 25 million and is eligible to receive up to
DKK 45 million in near-term development, regulatory and
manufacturing-based milestones. Zealand is also eligible to receive
up to DKK 220 million in sales-based milestones and tiered
royalties ranging from high single-digit to low double-digit
percentages on worldwide net sales of ZEGALOGUE® to be marketed by
Novo Nordisk. Zealand will be responsible for certain planned
regulatory, development and manufacturing activities to support
further development and approval outside of the U.S.
“We are extremely pleased to partner with Novo Nordisk, a global
leader in diabetes, to bring Zegalogue® to many more patients
around the world,” said Adam Steensberg, MD, Chief Executive
Officer of Zealand Pharma. “This agreement is another important
step in our strategy to establish commercial partnerships as we
create and develop innovative next generation peptide
therapeutics.”
“Although modern diabetes therapy has significantly reduced the
occurrence of very low blood sugar levels, or hypoglycemia, for
people with diabetes it remains feared and potentially serious,”
said Camilla Sylvest, Executive Vice President at Novo Nordisk. “As
a world leader in diabetes care, we aim to provide convenient and
simple to use solutions for people with diabetes experiencing
severe hypoglycemic episodes. We are therefore excited to add
Zegalogue® to our portfolio of therapies.”
Zealand will retain all non-licensed intellectual property
rights to the company’s other dasiglucagon development programs.
Today’s news does not impact Zealand’s Financial Guidance for 2022
as reiterated in the company’s Interim Report for the second
quarter and first half of 2022 announced on August 11, 2022.
About Zegalogue®
Zegalogue® (dasiglucagon) injection was approved by the U.S. FDA
on March 22, 2021 for the treatment of severe hypoglycemia in
people with diabetes. Zegalogue® is available in both an auto
injector and a prefilled syringe for patients with diabetes age 6
or older. The approval was based on results from three pivotal
trials in adults and children with diabetes, showing a median time
to blood glucose recovery from severe hypoglycemia of 10 minutes
following injection of 0.6 mg/0.6 mL of Zegalogue®. In these Phase
3 trial results the most common adverse events reported (≥2%) were
nausea, vomiting, headache, diarrhea, and injection site pain in
adults; and nausea, vomiting, headache and injection site pain in
pediatric patients.
Zegalogue® launched in the U.S. in late June 2021.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology
company focused on the discovery and development of peptide-based
medicines. More than 10 drug candidates invented by Zealand have
advanced into clinical development, of which two have reached the
market and three candidates are in late-stage development. The
company has development partnerships with a number of blue-chip
pharma companies as well as commercial partnerships for its
marketed products.
Founded in 1998 and headquartered in Copenhagen, Denmark,
Zealand has a team in the U.S. For more information about
Zealand’s business and activities, please
visit http://www.zealandpharma.com.
Forward-Looking Statements
This press release contains “forward-looking statements”, as
that term is defined in the Private Securities Litigation Reform
Act of 1995, as amended, that provide Zealand Pharma’s expectations
or forecasts of future events regarding the research, development
and commercialization of pharmaceutical products, the timing of the
company’s clinical trials and the reporting of data therefrom and
the company’s Events Anticipated in and Financial Guidance for
2022. These forward-looking statements may be identified by words
such as “aim,” “anticipate,” “believe,” “could,” “estimate,”
“expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,”
“potential,” “will,” “would” and other words and terms of similar
meaning. You should not place undue reliance on these statements,
or the scientific data presented. The reader is cautioned not to
rely on these forward-looking statements. Such forward-looking
statements are subject to risks, uncertainties and inaccurate
assumptions, which may cause actual results to differ materially
from expectations set forth herein and may cause any or all of such
forward-looking statements to be incorrect, and which include, but
are not limited to, unexpected costs or delays in clinical trials
and other development activities due to adverse safety events or
otherwise; unexpected concerns that may arise from additional data,
analysis or results obtained during clinical trials; our ability to
successfully market both new and existing products; changes in
reimbursement rules and governmental laws and related
interpretation thereof; government-mandated or market-driven price
decreases for our products; introduction of competing products;
production problems; unexpected growth in costs and expenses; our
ability to effect the strategic reorganization of our businesses in
the manner planned; failure to protect and enforce our data,
intellectual property and other proprietary rights and
uncertainties relating to intellectual property claims and
challenges; regulatory authorities may require additional
information or further studies, or may reject, fail to approve or
may delay approval of our drug candidates or expansion of product
labeling; failure to obtain regulatory approvals in other
jurisdictions; exposure to product liability and other claims;
interest rate and currency exchange rate fluctuations; unexpected
contract breaches or terminations; political uncertainty, including
due to the ongoing military conflict in Ukraine; and the direct and
indirect impacts of the ongoing COVID-19 pandemic on our business,
results of operations and financial condition. If any or all of
such forward-looking statements prove to be incorrect, our actual
results could differ materially and adversely from those
anticipated or implied by such statements. The foregoing sets forth
many, but not all, of the factors that could cause actual results
to differ from our expectations in any forward-looking statement.
All such forward-looking statements speak only as of the date of
this press release and are based on information available to
Zealand Pharma as of the date of this release. We do not undertake
to update any of these forward-looking statements to reflect events
or circumstances that occur after the date hereof. Information
concerning pharmaceuticals (including compounds under development)
contained within this material is not intended as advertising or
medical advice.
Contacts
For Zealand
Pharma: |
|
Anna Krassowska, PhD
(Investors & Media) |
Vice President,
Investor Relations & Corporate Communications |
Zealand Pharma
A/S |
ank@zealandpharma.com |
|
David Rosen (U.S.
Media) |
Argot Partners |
media@zealandpharma.com |
|
For Novo
Nordisk: |
|
Ambre Brown Morley
(Media) |
Novo Nordisk A/S |
+45 3079 9289 |
abmo@novonordisk.com |
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