As reported on PharmaBiz, GENESIS Pharma has announced an exclusive agreement with Otsuka Pharmaceutical Europe Ltd. (OPEL) to distribute and commercialize donidalorsen across 14 Central and Eastern European countries, including Greece, Poland, and Romania. The partnership strengthens GENESIS Pharma’s rare disease portfolio and expands access to innovative therapies in the region.
Donidalorsen, an investigational RNA-targeted therapy developed by Ionis Pharmaceuticals and licensed to Otsuka in 2023, is designed to reduce prekallikrein (PKK) production, a key driver of hereditary angioedema (HAE) attacks. In November 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending EU marketing authorization for the drug in preventing recurrent HAE episodes in patients aged 12 and older. The European Commission’s final decision is pending.
HAE is a rare genetic condition defined by unpredictable and possibly fatal swelling episodes affecting various parts of the body, including the airway. The impacts approximately 15,000 people in Europe and significantly disrupts quality of life.
GENESIS Pharma, established in 1997, specializes in bringing advanced biopharmaceuticals to patients with severe and rare diseases across Central and Eastern Europe. Managing Director Constantinos Evripides emphasized the company’s commitment to improving access to cutting-edge treatments for underserved patient populations.
