Ascendis Pharma Opens Compassionate Use Program for TransCon™ PTH (palopegteriparatide) in Germany
05 Junho 2023 - 6:30PM
Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has
started enrollment for a Compassionate Use Program (CUP) in Germany
for TransCon PTH (palopegteriparatide), an investigational prodrug
designed to provide sustained release of active parathyroid hormone
(PTH 1-34) within the physiological range for 24 hours per day in
adult patients with hypoparathyroidism with once-daily
administration. The CUP was approved by Germany’s Federal Institute
for Drugs & Medical Devices (Bundesinstitut für Arzneimittel
& Medizinprodukte, or BfArM).
“We are pleased to offer this pre-approval Compassionate Use
Program for TransCon PTH for eligible patients in Germany to
address the unmet medical needs of this patient community,” said
Moritz Meissner, M.D., Ascendis Pharma’s Head of Medical Affairs
Germany. “Because therapy with oral calcium and active vitamin D
aims to control and alleviate hypocalcemic symptoms in patients but
does not address the underlying cause of hypoparathyroidism – and
importantly, does not address PTH physiology and may itself be
associated with secondary complications – we remain committed to
advancing potential new treatment options for this disease.”
Through the CUP, treating physicians can request TransCon PTH
(palopegteriparatide) for eligible adult patients with
hypoparathyroidism whose clinical condition, in the opinion of the
treating physician, requires PTH treatment with
palopegteriparatide, and who cannot be adequately treated with
currently approved products or participate in a palopegteriparatide
clinical trial.
Physicians in Germany who are interested in the TransCon PTH
(palopegteriparatide) CUP can request full information and initiate
enrollment by contacting ascendis.medical@mytomorrows.com.
About Compassionate Use in GermanyIn Germany,
access to medicinal products that have not yet received marketing
authorization may be allowed if sufficient indications of the
efficacy and safety of the medicinal product exist and if a
clinical trial is being conducted on it, or if an application for a
marketing authorization has been submitted to the European
Medicines Agency (EMA). Information on current compassionate use
programs in Germany can be found on the website of the Federal
Institute for Drugs & Medical Devices (Bundesinstitut für
Arzneimittel & Medizinprodukte, or BfArM) here.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative TransCon technology platform to build a
leading, fully integrated, global 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). 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) TransCon PTH’s
ability to address the unmet medical needs of eligible patients in
Germany, (ii) Ascendis’ ability to advance potential new treatment
options for hypoparathyroidism, (iii) Ascendis’ ability to apply
its TransCon technology 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 its 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, and 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, and TransCon are trademarks owned by the Ascendis Pharma
group. © June 2023 Ascendis Pharma A/S.
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Ascendis Pharma |
Ascendis Pharma |
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+1 (650) 709-8875 |
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media@ascendispharma.com |
ir@ascendispharma.com |
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