Ascendis Pharma Launches SKYTROFA® (lonapegsomatropin) in Germany for the Once-Weekly Treatment of Children and Adolescents with Growth Hormone Deficiency
15 Setembro 2023 - 9:00AM
Ascendis Pharma A/S (Nasdaq: ASND) today announced the launch
in Germany of SKYTROFA® (lonapegsomatropin), its growth hormone
approved in the European Union for the once-weekly treatment of
children and adolescents ages 3 to 18 years with growth failure due
to insufficient endogenous growth hormone secretion (growth hormone
deficiency, or GHD).
“SKYTROFA is designed to deliver unmodified somatropin, the same
growth hormone used in daily pediatric GHD treatments for more than
30 years, and we are pleased now to make it available in Germany,”
said Camilla Harder Hartvig, Executive Vice President and Global
Chief Commercial Officer at Ascendis Pharma. “This first European
Union launch of SKYTROFA begins acceleration of its
commercialization beyond the U.S. as we work to expand our
leadership to new geographies.”
SKYTROFA (developed as TransCon hGH) was approved for pediatric
GHD by the US Food & Drug Administration (FDA) in 2021 and by
the European Commission (EC) in 2022.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative TransCon technology platform to build a
leading, fully integrated biopharma company focused on making a
meaningful difference in patients’ lives. Guided by its core values
of patients, science and passion, the company uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark and has additional
facilities in Germany (Heidelberg, Berlin and Munich) and the
United States (Palo Alto and Redwood City, California, and
Princeton, New Jersey). Please visit ascendispharma.com to learn
more.
Forward-Looking Statements This press release
contains forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statements of
historical facts, included in this press release regarding
Ascendis’ future operations, plans and objectives of management are
forward-looking statements. Examples of such statements include,
but are not limited to, statements relating to (i) SKYTROFA’s
ability to deliver unmodified somatropin; (ii) Ascendis’
expectations regarding the acceleration of its commercialization of
SKYTROFA beyond the United States; (iii) Ascendis’ ability to apply
its TransCon platform to build a leading, fully integrated, global
biopharma company, and (iv) Ascendis’ use of its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis may not actually achieve the plans, carry out the
intentions or meet the expectations or projections disclosed in the
forward-looking statements and you should not place undue reliance
on these forward-looking statements. Actual results or events could
differ materially from the plans, intentions, expectations and
projections disclosed in the forward-looking statements. Various
important factors could cause actual results or events to differ
materially from the forward-looking statements that Ascendis makes,
including the following: dependence on third party manufacturers,
distributors and service providers for Ascendis’ products and
product candidates; unforeseen safety or efficacy results in
Ascendis’ development programs or on-market products; unforeseen
expenses related to commercialization of any approved Ascendis
products; unforeseen expenses related to Ascendis’ development
programs; unforeseen selling, general and administrative expenses,
other research and development expenses and Ascendis’ business
generally; delays in the development of its programs related to
manufacturing, regulatory requirements, speed of patient
recruitment or other unforeseen delays; Ascendis’ ability to obtain
additional funding, if needed, to support its business activities;
the impact of international economic, political, legal, compliance,
social and business factors, including inflation, the effects on
its business from the worldwide COVID-19 pandemic and ongoing
conflicts such as that in the region surrounding Ukraine and
Russia. For a further description of the risks and uncertainties
that could cause actual results to differ from those expressed in
these forward-looking statements, as well as risks relating to
Ascendis’ business in general, see Ascendis’ Annual Report on Form
20-F filed with the U.S. Securities and Exchange Commission (SEC)
on February 16, 2023 and Ascendis’ other future reports filed with,
or submitted to, the SEC. Forward-looking statements do not reflect
the potential impact of any future licensing, collaborations,
acquisitions, mergers, dispositions, joint ventures, or investments
that Ascendis may enter into or make. Ascendis does not assume any
obligation to update any forward-looking statements, except as
required by law.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company
logo, TransCon, and SKYTROFA® are trademarks owned by the Ascendis
Pharma group. © September 2023 Ascendis Pharma A/S.
Investor Contacts: |
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Media Contact: |
Tim Lee |
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Melinda Baker |
Ascendis Pharma |
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Ascendis Pharma |
+1 (650) 374-6343 |
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+1 (650) 709-8875 |
tle@ascendispharma.com |
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media@ascendispharma.com |
ir@ascendispharma.com |
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Patti Bank |
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ICR Westwicke |
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+1 (415) 513-1284 |
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patti.bank@westwicke.com |
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