GENESIS Pharma, a regional biopharma company specialising in the commercialisation of innovative medicines in Central and Eastern Europe (CEE), has entered into an exclusive agreement with Otsuka Pharmaceutical Europe Ltd., the European arm of Otsuka Pharmaceutical Co., Ltd., for the distribution and commercialisation of donidalorsen.

Under the agreement, GENESIS Pharma will exclusively market donidalorsen across fourteen countries: 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 adopted a positive opinion recommending marketing authorisation for donidalorsen for the routine prevention of recurrent hereditary angioedema attacks in adults and adolescents aged 12 years and above. The opinion is currently under review by the European Commission, which will determine the medicine’s approval in the European Union. Donidalorsen is an investigational RNA-targeted therapy designed to reduce the production of prekallikrein, thereby interrupting the biological pathway that leads to hereditary angioedema attacks.

Commenting on the partnership, Constantinos Evripides, Managing Director of GENESIS Pharma, said the collaboration strengthens the company’s presence in the CEE region and enhances its rare disease portfolio. He added that the agreement aligns with GENESIS Pharma’s mission to improve access to innovative therapies for patients with serious and rare conditions, and expressed optimism ahead of the European Commission’s forthcoming decision.

Donidalorsen was discovered and developed by Ionis Pharmaceuticals. In December 2023, Otsuka acquired exclusive European commercialisation rights for the therapy through a licensing agreement with Ionis.

Hereditary angioedema is a rare, chronic and potentially life-threatening genetic disorder characterised by recurrent and unpredictable swelling episodes that may affect the limbs, face, abdomen, genitals and airways. Symptoms often begin in childhood or early adulthood and can place a significant physical, emotional and social burden on patients and their families. The condition is most commonly caused by a deficiency or dysfunction of C1 esterase inhibitor, leading to excessive bradykinin production. Around 15,000 people are estimated to be living with hereditary angioedema in Europe, with a global prevalence of approximately one in 50,000.

Founded in 1997, GENESIS Pharma focuses on the commercialisation of biopharmaceutical products for severe and rare diseases and was among the first companies in Europe to specialise in this segment.