Ascendis Pharma Receives Positive CHMP Opinion for TransCon™ PTH (palopegteriparatide) for Adults with Chronic Hypoparathyroidism
14 Setembro 2023 - 1:22PM
Ascendis Pharma A/S (Nasdaq: ASND) today announced that the
European Medicines Agency’s Committee for Medicinal Products for
Human Use (CHMP) has adopted a positive opinion and recommended the
approval of TransCon PTH (palopegteriparatide) as a parathyroid
hormone (PTH) replacement therapy indicated for the treatment of
adults with chronic hypoparathyroidism. The European Commission’s
final decision on the Company’s Marketing Authorisation Application
is expected within 67 days after the positive opinion. TransCon PTH
is a prodrug of parathyroid hormone (PTH [1-34]) administered once
daily.
“We are pleased to have received this positive CHMP opinion for
TransCon PTH and look forward to the final European Commission
decision,” said Birgitte Volck, M.D., Ph.D., Executive Vice
President, Head of Clinical Development & Medical Affairs,
Endocrinology Rare Diseases at Ascendis Pharma. “Hypoparathyroidism
is the last endocrine deficiency for which replacement of the
missing hormone is not widely available. Based on our clinical and
patient-reported data and a robust supply chain, we are confident
in our ability to address the hypoparathyroidism community’s urgent
need for new treatment options to safely and effectively address
the burden of their disease.”
CHMP adopted its positive opinion following its review of the
totality of the Company’s clinical package for TransCon PTH
(palopegteriparatide), which included data from the global Phase 3
PaTHway and Phase 2 PaTH Forward trials in adult patients with
hypoparathyroidism, both of which used the same drug/device
combination product that Ascendis plans to make available as its
commercial product, if approved. Ascendis plans its first European
Union launch of TransCon PTH (palopegteriparatide), if approved, in
Germany in early 2024.
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) the timing of
the final European Commission decision on the approval of TransCon
PTH; (ii) Ascendis’ plans to launch TransCon PTH in Germany in
early 2024, if approved; (iii) Ascendis’ ability to address the
hypoparathyroidism community’s urgent need for new treatment
options that safely and effectively address the burden of their
disease; (iv) Ascendis’ plan to make available the same drug/device
combination used in the Phase 3 PaTHway Trial and the Phase 2 PaTH
Forward trials as its commercial product for TransCon PTH, if
approved; (v) Ascendis’ ability to apply its TransCon platform to
build a leading, fully integrated, global biopharma company, and
(vi) 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, and TransCon ® are trademarks owned by the Ascendis Pharma
group. © September 2023 Ascendis Pharma A/S.
Investor Contacts: |
Media Contact: |
Tim Lee |
Melinda Baker |
Ascendis Pharma |
Ascendis Pharma |
+1 (650) 374-6343 |
+1 (650) 709-8875 |
tle@ascendispharma.com |
media@ascendispharma.com |
ir@ascendispharma.com |
|
|
|
Patti Bank |
|
ICR Westwicke |
|
+1 (415) 513-1284 |
|
patti.bank@westwicke.com |
|
Ascendis Pharma AS (NASDAQ:ASND)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Ascendis Pharma AS (NASDAQ:ASND)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024