Ascendis Pharma A/S Announces US Commercial Launch of SKYTROFA (Lonapegsomatropin-tcgd), the First and Only FDA Approved Once-Weekly Treatment for…

COPENHAGEN, Denmark, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), today announced the U.S. commercial launch of SKYTROFA (lonapegsomatropin-tcgd), its once-weekly treatment for the treatment of pediatric patients one year and older who weigh at least 11.5 kg (25.4 lb) and have growth failure due to inadequate secretion of endogenous growth hormone (GH). SKYTROFA (lonapegsomatropin-tcgd) is available by prescription and distributed through a network of specialty pharmacies across the United States.

SKYTROFA offers patients, caregivers, and physicians the potential to replace daily somatropin injections that have been the standard of care for more than 30 years, said Jan Mikkelsen, Ascendis Pharmas President and Chief Executive Officer. As the first and only FDA-approved once-weekly therapy for pediatric growth hormone deficiency, SKYTROFA represents one of the most important innovations for these patients in decades.

Reflecting its commitment to patients, Ascendis Pharma has also launched the Ascendis Signature Access Program, a personalized patient support program in the U.S. dedicated to working with families, caregivers, and physicians from decision to treat through long-term therapy adherence. The program is staffed by nurses and offers a full suite of services including, but not limited to, prior authorization support, out of pocket assistance, and training on proper injection procedures.

The full commercial launch of SKYTROFA (lonapegsomatropin-tcgd) marks an important milestone as the Company continues to deliver on its Vision 3x3 strategic roadmap through 2025 to build a leading global biopharma company by achieving sustainable growth through multiple approaches.

The Following Information is Intended for the U.S. Audience Only

INDICATION

SKYTROFA is a human growth hormone indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH).

IMPORTANT SAFETY INFORMATION

You are encouraged to report side effects to FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1-844-442-7236.

Please click here for full Prescribing Information for SKYTROFA.

About SKYTROFA (lonapegsomatropin-tcgd)SKYTROFA (lonapegsomatropin-tcgd) is a once-weekly prodrug designed to deliver somatropin over a one-week period. The released somatropin has the same 191 amino acid sequence as daily somatropin. SKYTROFA (lonapegsomatropin-tcgd) single-use, prefilled cartridges are available in nine dosage strengths, allowing for convenient dosing flexibility. They are designed for use only with the SKYTROFA Auto-Injector and may be stored at room temperature for up to six months. The recommended dose of SKYTROFA (lonapegsomatropin-tcgd) for treatment-nave patients and patients switching from daily somatropin is 0.24 mg/kg body weight, administered once weekly. The dose may be adjusted based on the childs weight and insulin-like growth factor-1 (IGF-1) SDS.

TransCon hGH (known by its brand name SKYTROFA (Lonapegsomatropin-tcgh) in the U.S.) has been studied in over 300 treatment-naive and treatment-experienced children with GHD across the Phase 3 program, which consists of the heiGHt Trial (for treatment-nave patients), the fliGHt Trial (for treatment-experienced and treatment-naive patients), and the enliGHten Trial (an ongoing long-term open-label extension trial). Patients who completed the heiGHt Trial or the fliGHt Trial were able to continue into the enliGHten Trial, and some have been treated with SKYTROFA (lonapegsomatropin-tcgd) for over four years.TransCon hGH is currently under review by the European Medicines Agency (EMA) in Europe as a potential treatment for pediatric growth hormone deficiency. In addition, TransCon hGH is being evaluated for pediatric GHD in Phase 3 trials in Japan and the Peoples Republic of China, Ascendis Pharma is also conducting the global Phase 3 foresiGHt Trial in adults with GHD. TransCon hGH has been granted orphan designation for GHD in both the U.S. and Europe.

About Ascendis Pharma A/SAscendis Pharma is applying its innovative platform technology 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 Heidelberg and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit http://www.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) Ascendis use of the Ascendis Signature Access Program to support the use of SKYTROFA (lonapegsomatropin-tcgd) by families, caregivers, and physicians, (ii) Ascendis use of its co-pay as well as a separate assistance program for patients and families facing financial need, (iii) Ascendis ability to apply its platform technology to build a leading, fully integrated 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 and distributors to supply TransCon hGH, the SKYTROFA Auto-Injector and other study drug for commercial sales in the U.S. and clinical studies; unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to commercialization of lonapegsomatropin-tcgd in the U.S., the co-pay program, and the further development of TransCon hGH, expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, selling, general and administrative expenses, other research and development expenses and Ascendis business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis ability to obtain additional funding, if needed, to support its business activities and the effects on its business from the worldwide COVID-19 pandemic. 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 March 10, 2021 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.

SKYTROFA, Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma Group. October 2021 Ascendis Pharma A/S.

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Ascendis Pharma A/S Announces US Commercial Launch of SKYTROFA (Lonapegsomatropin-tcgd), the First and Only FDA Approved Once-Weekly Treatment for...