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COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, evolved as TransCon PTH), a parathyroid hormone (PTH) replacement cure. Indicated for Treatment for adults with chronic hypoparathyroidism is now available in Germany and Austria. YORVIPATH is the second product developed with Ascendis Pharma’s TransCon generation platform to be commercially launched.
“We are pleased to launch YORVIPATH to address the need expressed within the hypoparathyroidism network for a new PTH-based treatment option,” said Jan Mikkelsen, President and CEO of Ascendis Pharma. In response to medical necessity, this launch of our second TransCon product represents a key milestone in our goal to launch the 3 rare endocrinology products for which, as a component of Vision 3×3, we aim to obtain regulatory approvals through 2025 and for each of which, as a component of Vision 2030, we aim to achieve highly successful prestige through 2030. With an ever-expanding advertising infrastructure, we are well-positioned to accomplish this by expanding the availability of YORVIPATH and our other approved products to meet the desires of physicians and patients. ” all over the world. “
About YORVIPATH YORVIPATH (palopegteriparatide, evolved as TransCon PTH) is a parathyroid hormone (PTH 1-34) prodrug that is administered once daily and is designed to provide parathyroid hormone levels within overall physiological diversity over a 24-hour dosing period. YORVIPATH was granted marketing authorization through the European Commission (EC) in November 2023 as a PTH replacement cure indicated for the treatment of adults with chronic hypoparathyroidism. In the UK, a resolution on YORVIPATH is expected from the European Commission.
Hypoparathyroidism is an endocrine disease caused by inadequate levels of PTH, the main regulator of the calcium/phosphate balance in the body, which acts directly on the bones, kidneys, and intestines. Hypoparathyroidism is considered chronic if it persists > 6 months. after surgery, according to the 2016 Society of Endocrinology guidelines, the 2019 Canadian and International Consensus Statement, and the 2022 European Society of Endocrinology Consensus Statement. People with hypoparathyroidism can experience a variety of serious, short- and long-term, life-threatening situations. complications, in addition to neuromuscular irritability, renal complications, extraskeletal calcifications and cognitive impairment. Postoperative hypoparathyroidism accounts for the majority of cases (70-80%); Other etiologies come with autoimmune diseases, familial disorders, and idiopathic causes.
About Ascendis Pharma A/SAscendis Pharma is your cutting-edge TransCon generation platform to create a leading, fully incorporated biopharmaceutical company that aims to make 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, with further services in Europe and the United States. Visit https://ascendispharma. com for more information.
Forward-Looking Statements This press release includes forward-looking statements that involve significant dangers and uncertainties. All statements, other than statements of past fact, included in this press release relating to Ascendis’ long-term operations, plans and control objectives are forward-looking statements. Examples of such statements include, but are not limited to, statements regarding (i) YORVIPATH’s ability to address the need for a new PTH-based remedy option, (ii) Ascendis’ objective to discharge the approval, launch and in achieving high standing for 3 rare disease products in endocrinology through 2030, (iii) Ascendis’ ability to expand the availability of YORVIPATH and its other approved products, (iv) the timeline for the MHRA resolution on YORVIPATH in the United Kingdom, (v) the FDA PDUFA date for TransCon PTH, (vi) Ascendis’ plan to expand the global success of its rare diseases portfolio in endocrinology, adding YORVIPATH, through exclusive distribution agreements, (vii) Ascendis’ ability to apply its TransCon generation platform to create a leading, fully formed biopharmaceutical company. Array and (viii) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, realize the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on such forward-looking statements. Actual effects or events may also differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Several vital points may also cause actual effects or occasions to differ materially from the forward-looking statements made through Ascendis, including the following: dependence on third-party manufacturers, distributors and service providers for Ascendis products and applicants for Ascendis products; unexpected protective or effective effects on Ascendis progression systems or products on the market; unforeseen expenses similar to advertising any approved Ascendis product; unforeseen expenses similar to Ascendis progression systems; unforeseen selling, general and administrative expenses, other research and progression pricing and Ascendis’ business generally; delays in the progression of its manufacturing-like systems, regulatory requirements, timeliness of patient recruitment or other unforeseen delays; Ascendis’s ability to obtain additional financing, if necessary, to assist its business operations; The impact on economic, political, legal, compliance, social and advertising issues abroad, including inflation, the effects on your business of the global COVID-19 pandemic and ongoing conflicts such as the one in the region surrounding Ukraine and Russia. For a more detailed description of dangers and uncertainties that may also cause actual effects to differ from those expressed in such forward-looking statements, as well as dangers relating to Ascendis’ business generally, please see Ascendis’ Annual Report at Form 20-F filed with the United States Securities and Exchange Commission (SEC) on February 16, 2023 and other long-term reports of Ascendis filed or filed with the SEC. Forward-looking statements do not reflect the potential impact of any licenses, collaborations, acquisitions, mergers, divestitures, joint ventures or long-term investments that Ascendis may participate in or make. Ascendis assumes no legal responsibility 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) [email protected]
Patti BankICR Westwicke 1 (415) 513-1284patti. bank@westwicke. com