COPENHAGEN, Denmark — 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 3×3 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 Hypoparathyroidism
Hypoparathyroidism 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/S
Ascendis 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.
| Investor Contacts: Tim Lee Ascendis Pharma +1 (650) 374-6343 [email protected] [email protected] |
Media Contact: Melinda Baker Ascendis Pharma +1 (650) 709-8875 [email protected] |
|
Patti Bank |