Agreements

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:

• monoclonal antibody. Isqette® is a monoclonal antibody that has been designed to recognise and attach to GD2 antigen. This antigen is present in high amounts on the surface of neuroblastoma cells, but not normal cells. When the medicine attaches to the neuroblastoma cells, it marks them out as a target for the body’s immune system, which is then expected to attack the cancer cells and thereby reverse or slow down the progression of the disease.
• Apeiron Biologics developed Isqette® together with academic partners, in particular with the Children's Cancer Research Institute (CCRI), associated with the St. Anna Children's Hospital, Vienna and SIOPEN (Society of Paediatric Oncology European Neuroblastoma Network).

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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Is general: Yes