14 January 2020 | News
EUSA Pharma and BeiGene Announce Exclusive Development and Commercialization Agreement for SYLVANT and QARZIBA in Greater China
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EUSA Pharma and BeiGene has announced that they have entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT (siltuximab) and QARZIBA (dinutuximab beta) in Greater China.
Under the terms of the agreement, EUSA has granted BeiGene exclusive rights to SYLVANT in Greater China and to QARZIBA in mainland China. Under the agreement, BeiGene will fund and undertake 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 be 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.
“Our teams are excited to work with EUSA to commercialize SYLVANT and QARZIBA, two important biologics which are already available to patients with rare diseases outside of China,” said Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. “This collaboration further demonstrates our commitment to bringing high quality therapies to people in China and around the world.”
Lee Morley, Chief Executive Officer of EUSA Pharma, said, “This exclusive agreement with BeiGene represents an important milestone for EUSA as we deliver on our promise to bring our innovative cancer and rare disease therapies to patients around the world. BeiGene brings to our collaboration exceptional development and commercialization capabilities in China and a clear focus on delivering innovative, targeted oncology medicines. We look forward to working together over the coming months to ensure these important orphan products are made available to Chinese patients.”
SYLVANT is currently 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. 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. Both products have been listed for fast-track approval in China by the National Medical Products Administration (NMPA) via its Review and Approval Procedures for Urgently-Needed Pharmaceutical Drugs Developed Overseas.