Ascendis Pharma Launches 2nd TransCon Product

YORVIPATH Now Available in Germany and Austria for Adults with Chronic Hypoparathyroidism

COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- 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.