GENESIS Pharma Partners with Otsuka for Donidalorsen in CEE

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.