Prime Highlights:
- GENESIS Pharma signs an exclusive partnership with Otsuka Pharmaceutical Europe to commercialize donidalorsen in 14 Central and Eastern European countries.
- Donidalorsen has received a positive recommendation from CHMP for preventing recurrent HAE attacks in people aged 12 and above.
Key Facts:
- HAE is a rare, serious condition causing sudden swelling in the hands, feet, face, abdomen, genitals, and airways.
- Around 15,000 people in Europe are affected by HAE, which often begins in childhood or early adulthood.
Background:
GENESIS Pharma, a leading biopharmaceutical company in the region, has signed an exclusive partnership with Otsuka Pharmaceutical Europe Ltd. (OPEL) to distribute donidalorsen, a new treatment for hereditary angioedema (HAE), in fourteen Central and Eastern European countries. These include Bulgaria, Croatia, Cyprus, the Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, and Slovenia.
In November 2025, the European regulatory body CHMP recommended donidalorsen to prevent repeated HAE attacks in people aged 12 and older. The European Commission is now reviewing it for final approval.
Donidalorsen lowers prekallikrein, a protein that causes HAE attacks, a rare condition leading to sudden swelling in various parts of the body. It usually starts in childhood or early adulthood. Around 15,000 people in Europe live with HAE, which can significantly affect daily life.
Mr. Constantinos Evripides, Managing Director of GENESIS Pharma, said: “We are thrilled to expand our partnerships in the CEE region with Otsuka Pharmaceutical Europe Ltd. Adding donidalorsen to our rare disease portfolio reinforces our commitment to supporting patients with serious conditions and ensuring access to innovative therapies.”
Donidalorsen was originally discovered by Ionis Pharmaceuticals and is now being developed in Europe under Otsuka’s exclusive rights. This partnership strengthens GENESIS Pharma’s role as a leading company in rare disease treatments, giving patients access to new therapies that can greatly improve their quality of life.
