Ascendis Pharma Launches 2nd TransCon™ Product: YORVIPATH® Now Available in Germany and Austria for Adults with Chronic Hypoparathyroidism
January 31 2024 - 4:01PM
Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH®
(palopegteriparatide, developed as TransCon PTH), a parathyroid
hormone (PTH) replacement therapy indicated for the treatment of
adults with chronic hypoparathyroidism, is now available in Germany
and Austria. YORVIPATH is the second product developed with
Ascendis Pharma’s TransCon technology platform to be launched
commercially.
“We are pleased to initiate the launch of YORVIPATH to address
the needs expressed within the hypoparathyroidism community for a
new PTH-based treatment option,” said Jan Mikkelsen, Ascendis
Pharma’s President and Chief Executive Officer. “In addition to
addressing a significant unmet medical need, this launch of our
second TransCon product represents a key milestone in our goal to
launch the three Endocrinology Rare Disease products for which,
under Vision 3x3 we target achieving regulatory approvals by 2025
and for each of which, under Vision 2030, we aim to achieve
blockbuster status by 2030. With an increasingly broad commercial
infrastructure in place, we are well positioned to accomplish this
by expanding the availability of YORVIPATH and our other approved
products to meet the needs of physicians and patients around the
world.”
About YORVIPATH YORVIPATH (palopegteriparatide,
developed as TransCon PTH) is a prodrug of parathyroid hormone (PTH
1-34) administered once daily, designed to provide parathyroid
hormone levels within the normal physiological range across the
24-hour dosing period. YORVIPATH was granted marketing
authorization by the European Commission (EC) in November 2023 as a
PTH replacement therapy indicated for the treatment of adults with
chronic hypoparathyroidism. A decision on YORVIPATH in the United
Kingdom is expected from the Medicines & Healthcare Products
Regulatory Agency (MHRA) during the first quarter of 2024. In the
United States, the U.S. Food & Drug Administration (FDA) has
set a PDUFA date of May 14, 2024 to complete their review of
Ascendis Pharma’s New Drug Application for TransCon PTH for adults
with chronic hypoparathyroidism. TransCon PTH is also in
development in Japan through Teijin Ltd. and China through VISEN
Pharmaceuticals. Internationally, Ascendis is working to expand the
global reach of its Endocrinology Rare Disease portfolio, including
YORVIPATH, through exclusive distribution agreements, three of
which have been established to date.
About HypoparathyroidismHypoparathyroidism is
an endocrine disease caused by insufficient levels of PTH, the
primary regulator of calcium/phosphate balance in the body, acting
directly on bone and kidneys and indirectly on intestines.
Hypoparathyroidism is considered chronic if it persists >6
months following surgery per the 2016 Endocrine Society Guidelines,
2019 Canadian and International Consensus Statement, and
2022 European Society of Endocrinology Consensus Statement.
Individuals with hypoparathyroidism may experience a range of
severe and potentially life-threatening short-term and long-term
complications, including neuromuscular irritability, renal
complications, extra-skeletal calcifications, and cognitive
impairment. Post-surgical hypoparathyroidism accounts for the
majority of cases (70-80%); other etiologies include autoimmune
disorders, familial disorders, and idiopathic causes.
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, Ascendis uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark and has additional
facilities in Europe and the United States. Please visit
https://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) YORVIPATH’s
ability to address the need for a new PTH-based treatment option,
(ii) Ascendis’ goal of obtaining approval for, launching and
achieving blockbuster status for three Endocrinology Rare Disease
products by 2030, (iii) Ascendis’ ability to expand the
availability of YORVIPATH and its other approved products, (iv) the
timing of the MHRA’s decision on YORVIPATH in the United Kingdom,
(v) the FDA’s PDUFA date for TransCon PTH, (vi) Ascendis’ plan to
expand the global reach of its Endocrinology Rare Disease
portfolio, including YORVIPATH, through exclusive distribution
agreements, (vii) Ascendis’ ability to apply its TransCon
technology platform to build a leading, fully integrated biopharma
company, and (viii) 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 YORVIPATH® are trademarks owned by the Ascendis
Pharma group. © January 2024 Ascendis Pharma A/S.
Investor Contacts:Tim LeeAscendis Pharma+1 (650)
374-6343tle@ascendispharma.comir@ascendispharma.com |
Media Contact:Melinda BakerAscendis Pharma+1 (650)
709-8875media@ascendispharma.com |
Patti BankICR Westwicke+1 (415)
513-1284patti.bank@westwicke.com |
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