Date: 2016-10-04
Type of information: Commercialisation agreement
Compound: Isqette® (APN311 - dinutuximab beta)
Company: Apeiron Biologics (Austria) EUSA Pharma (UK)
Therapeutic area: Rare diseases - Cancer - Oncology
Type agreement: commercialisation
Action mechanism:
Disease: neuroblastoma
Details: • On October 4, 2016, Apeiron Biologics, a private biotech company developing immunological therapies against cancer, announced that it grants EUSA Pharma, exclusive global commercialization rights to Isqette® (APN311, dinutuximab beta). In Europe, dinutuximab beta is used in clinical trials as part of the regimen for the treatment of high risk neuroblastoma with approx. one thousand patients treated and is available under a managed access program. The product has orphan drug designation in the US and EU and is currently under review for marketing approval by the European Medicines Agency (EMA). EUSA Pharma intends to continue EUSA Pharma, exclusive global commercialization rights to Isqette® (APN311, dinutuximab beta).'s managed access program, and once approved in Europe will promote the immunotherapy to oncologists through its specialty sales team. In the United States, EUSA plans to submit a regulatory filing in 2017, and once approved will commercialize the product directly through its established US infrastructure. In other territories, including Japan, EUSA plans to bring the product to market through its international network of partners.
Financial terms: Under the terms of the agreement, Apeiron receives an upfront fee, regulatory milestone payments upon marketing approval in key territories and royalties on future product sales.
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