Ascendis Pharma Launches SKYTROFA® (lonapegsomatropin) in Germany for the Once-Weekly Treatment of Children and Adolescents with Growth Hormone Deficiency

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COPENHAGEN, Denmark, Sept. 15, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced the launch in Germany of SKYTROFA® (lonapegsomatropin), its growth hormone approved in the European Union for the once-weekly treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient endogenous growth hormone secretion (growth hormone deficiency, or GHD).

“SKYTROFA is designed to deliver unmodified somatropin, the same growth hormone used in daily pediatric GHD treatments for more than 30 years, and we are pleased now to make it available in Germany,” said Camilla Harder Hartvig, Executive Vice President and Global Chief Commercial Officer at Ascendis Pharma. “This first European Union launch of SKYTROFA begins acceleration of its commercialization beyond the U.S. as we work to expand our leadership to new geographies.”

SKYTROFA (developed as TransCon hGH) was approved for pediatric GHD by the US Food & Drug Administration (FDA) in 2021 and by the European Commission (EC) in 2022.

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) SKYTROFA’s ability to deliver unmodified somatropin; (ii) Ascendis’ expectations regarding the acceleration of its commercialization of SKYTROFA beyond the United States; (iii) Ascendis’ ability to apply its TransCon platform to build a leading, fully integrated, global biopharma company, and (iv) 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 SKYTROFA® are trademarks owned by the Ascendis Pharma group. © September 2023 Ascendis Pharma A/S.

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Source: Ascendis Pharma

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