Rare Daily Staff
EUSA Pharma has entered into an exclusive development and commercialization agreement with BeiGene for the development and commercialization of the rare disease therapies Sylvant and Qarziba in Greater China.
Sylvant is approved in more than 40 countries worldwide for the treatment of idiopathic multicentric Castleman’s disease (iMCD), a rare, life-threatening and debilitating orphan condition of the lymph nodes and related tissues. It is a monoclonal antibody that blocks the action of interleukin-6, a multifunctional cytokine detected at elevated levels in iMCD patients.
Qarziba is the only EMA approved targeted immunotherapy for the treatment of high-risk neuroblastoma, an aggressive neoplasm and the most common childhood solid tumor that originates outside of the brain. It is a monoclonal antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells.
Both products have been listed for fast-track approval in China by the National Medical Products Administration via its Review and Approval Procedures for Urgently-Needed Pharmaceutical Drugs Developed Overseas.
Under the terms of the agreement, EUSA has granted BeiGene exclusive rights to Sylvant in Greater China, and to Qarziba in mainland China. BeiGene will fund and be responsible for all clinical development and regulatory submissions in the territories and will launch and commercialize both products once approved.
EUSA will receive an upfront payment and is eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $160 million. EUSA will also be eligible to receive tiered royalties on future product sales.
“BeiGene brings to our collaboration exceptional development and commercialization capabilities in China and a clear focus on delivering innovative, targeted oncology medicines,” said Lee Morley, CEO of EUSA Pharma.
Photo: Lee Morley, CEO of EUSA Pharma.