Broadened agreement now addresses the unmet need for novel rare endocrinology disease therapies in Central and Eastern Europe and Eurasian markets
ATHENS, Greece and ALMATY, Kazakhstan, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Er-Kim, an international pharmaceutical company specializing in the commercialization of novel therapies, today announced that it has extended its exclusive agreement with Danish biopharmaceutical company Ascendis Pharma A/S (Nasdaq: ASND) to commercialize three rare endocrinology disease treatments in selected countries across Eurasia. Er-Kim originally announced its exclusive agreement with Ascendis to distribute these therapies across Central and Eastern Europe and Turkey in January 2024.
Under this agreement extension, Er-Kim is now appointed as the exclusive Ascendis A/S endocrinology rare disease representative in the additional countries of Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, and Uzbekistan.
The therapies included in the portfolio are SKYTROFA® (lonapegsomatropin)1,2 YORVIPATH® (palopegteriparatide)3,4, and TransCon CNP (navepegritide)5.
- Once-weekly SKYTROFA (lonapegsomatropin) is a human growth hormone (hGH) approved in the European Union for growth failure in children and adolescents aged from 3 to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]) 2 and in the United States for pediatric patients 1 year and older and have growth failure due to inadequate secretion of growth hormone1.
- YORVIPATH (palopegteriparatide) is a first-in-class parathyroid hormone (PTH) replacement therapy to treat chronic hypoparathyroidism, a rare and potentially serious condition where the body produces no or abnormally low levels of PTH. It is approved in the European Union as a replacement therapy for the treatment of adults with chronic hypoparathyroidism3 and in the United States for the treatment of hypoparathyroidism in adults4.
- A third product - TransCon CNP (navepegritide) - is in clinical development by Ascendis Pharma for the treatment of achondroplasia (ACH), the most common genetic form of skeletal dysplasia and resulting disproportionate short stature, following the completion of pivotal ApproaCH trial5.
"At Ascendis Pharma we are driven by our commitment to make a meaningful difference in the lives of patients,” said Camilla Harder Hartvig, Ascendis Pharma's EVP, President Europe & International. "We are therefore pleased to extend our existing partnership with Er-Kim to further broaden patient access to our innovative Endocrinology Rare Disease treatment options across Eurasia.”
About Er-Kim
Established in 1981, Er-Kim stands at the forefront of biopharmaceutical innovation, partnering with over 40 global leaders to revolutionize patient care in key international markets. Our pioneering business models, tailored for sustainability and flexibility, have positioned us as a full-service solution, extending our reach to over 600 million patients through our fully owned affiliates. With a dedicated team of over 280 professionals worldwide and revenues exceeding EUR 230M, Er-Kim is not just a partner but a trailblazer in healthcare, continually setting new standards in commercialization and patient access. For more information, please visit http://www.er-kim.com/.
About Ascendis Pharma
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, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Please visit https://ascendispharma.com to learn more.
About SKYTROFA (lonapegsomatropin)
SKYTROFA® (lonapegsomatropin, developed as TransCon™ hGH) is a prodrug of somatropin, designed to provide sustained release of unmodified somatropin. The unmodified, unbound somatropin released from lonapegsomatropin has the same 191 amino acid sequence and size as endogenous GH.6 TransCon hGH is approved and marketed as SKYTROFA (lonapegsomatropin-tcgd) in the United States1 and as SKYTROFA (lonapegsomatropin) in the European Union2 as a once-weekly treatment for children and adolescents with GHD. Ascendis Pharma is also conducting the ongoing global Phase 3 Foresight Trial of TransCon hGH in adults with GHD.7
About YORVIPATH (palopegteriparatide)
YORVIPATH® (palopegteriparatide, developed as TransCon™ PTH) is a once-daily prodrug providing sustained release of active PTH. It was approved by the European Union as a parathyroid hormone (PTH) replacement therapy for the treatment of adults with chronic hypoparathyroidism3. Treatment should be initiated and monitored by physicians or qualified healthcare professionals experienced in the diagnosis and management of patients with hypoparathyroidism and the United States for the treatment of hypoparathyroidism in adults4.
About TransCon CNP (navepegritide)
TransCon™ CNP (navepegritide) is an investigational long-acting prodrug of C-type natriuretic peptide (CNP), designed to provide continuous exposure of CNP at safe, therapeutic levels, via a single, weekly subcutaneous dose, for the treatment of children with ACH.8
References
- SKYTROFA (lonapegsomatropin-tcgd) US Prescribing Information.
- SKYTROFA (lonapegsomatropin) EU Summary of Product Characteristics.
- YORVIPATH (palopegteriparatide) EU Summary of Product Characteristics.
- YORVIPATH (palopegteriparatide) US Prescribing Information
- Ascendis Pharma A/S, Pivotal ApproaCH Trial of TransCon™ CNP (Navepegritide) Achieved Primary Objective, Demonstrated AGV Superior to Placebo, Press Release,
16 September 2024:
- Thornton PS, Maniatis AK, Aghajanova E, et al., J Clin Endocrinol Metab. 2021;106(11):3184-3195.
- Foresight Trial (NCT05171855), https://clinicaltrials.gov/study/NCT05171855.
- Tritos NA, Biller BMK. Current concepts of the diagnosis of adult growth hormone deficiency. Rev Endocr Metab Disord. 2020;22(1):109-116.
Rosalia Scampoli
Marketcom PR
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