GENESIS Pharma announces a new partnership with Otsuka Pharmaceutical Europe Ltd. for the commercialization of donidalorsen for hereditary angioedema in Central and Eastern Europe

ANNOUNCEMENT FOR EUROPEAN MEDICAL & PHARMACEUTICAL TRADE MEDIA AND EUROPEAN FINANCIAL MEDIA ONLY

GENESIS Pharma, a regional biopharma company focused on the commercialization of innovative medicines in Central and Eastern Europe, announces an exclusive agreementwithOtsuka Pharmaceutical Europe Ltd. (OPEL), the European operation of global healthcare company Otsuka Pharmaceutical Co., Ltd., for donidalorsen. Under the terms of the agreement, GENESIS Pharma will exclusively distribute and commercializedonidalorsen in fourteen markets: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia and Slovenia.

In November 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for donidalorsen in the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The CHMP opinion is currently under review by the European Commission (EC), to determine donidalorsen’s authorisation in the European Union (EU). Donidalorsen is an investigational RNA-targeted medicine designed to reduce the production of prekallikrein (PKK), interrupting the pathway that leads to HAE attacks^1,2.

Mr. Constantinos Evripides, Managing Director of GENESIS Pharma stated: “We are excited to expand our international partnerships in the CEE region through this new collaboration with Otsuka Pharmaceutical Europe Ltd., a company focusing on some of the world’s unresolved health issues. The addition of donidalorsen to our robust rare disease medicines portfolio is another step forward in our mission to support patients with rare and serious conditions, ensuring access to innovative treatments in our region. Thus, we look forward to the forthcoming decision from the European Commission.”

Donidalorsen was discovered and developed by Ionis Pharmaceuticals, Inc. (Ionis). In December 2023, Otsuka acquired exclusive rights to commercialize donidalorsen in Europe through a licensing agreement with Ionis.

About Hereditary Angioedema (HAE)

HAE is a rare, chronic and potentially life-threatening genetic condition that involves recurrent, unpredictable attacks of swelling episodes that can affect the extremities, face, abdomen, genitals and even the larynx, posing serious risk for patients.³ Symptoms of HAE usually begin in childhood or early adulthood, with some individuals experiencing their first episodes as young as two years old.^4,5HAE imposes a significant burden on patients and their families, with unpredictable and often debilitating attacks which can disrupt daily life, limit activities and reduce productivity at work or school. ^6-8 HAE is most commonly caused by an inherited deficiency or dysfunction of C1 esterase inhibitor, which leads to uncontrolled activation of the plasma kallikrein-kinin system and excessive production of bradykinin.^5,9,10Approximately 15,000 individuals are living with HAE in Europe with a worldwide prevalence estimated to be 1 in 50,000.^3,5,11

About GENESIS Pharma

GENESIS Pharma is a regional biopharma company focused on the commercialization of innovative biopharmaceutical products targeting severe and rare diseases in Central and Eastern Europe. Established in 1997, GENESIS Pharma was among the first pharmaceutical companies in Europe to specialize in the marketing, sales and distribution of biopharmaceutical products. GENESIS Pharma maintains a strong portfolio in therapeutic areas with high unmet medical need through long standing strategic alliances with some of the leading global biopharma companies. For more information, please visit www.genesispharma.com and follow us on LinkedIn.

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7. Chong-Neto HJ, World Allergy Organ J 2023;16(3):100758.
8. Mendivil J, et al. Orphanet J Rare Dis 2021;16:94.
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10. Longhurst HJ, Bork K. Br J Hosp Med (Lond) 2019:2;80(7):391–398.
11. Lumry WR. Hereditary angioedema: the economics of treatment of an orphan disease. Front Med (Lausanne). 2018;5:22.

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