On October 4, 2016 EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, reported the acquisition of exclusive global commercialization rights to the oncology product dinutuximab beta from Apeiron Biologics (Press release, EUSA Pharma, OCT 4, 2016, View Source [SID1234527664]). Dinutuximab beta is currently used as part of the regimen for the treatment of high risk neuroblastoma in Europe and is available under a managed access program. The immunotherapy has orphan drug designation in the US and EU and is currently under review for marketing authorization by the EMA. EUSA expects to file the product for registration in the US and Japan in 2017.
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Under the terms of the agreement, EUSA Pharma will pay Apeiron an upfront fee, with a portion contingent on EU approval. EUSA will also pay regulatory milestone payments in other key territories and royalties on future product sales.
Neuroblastoma is an orphan oncology indication with significant unmet medical need. It accounts for up to 10% of childhood tumors and affects approximately 1,200 children in the EU5 and US each year. Consequently, EUSA Pharma intends to continue 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, the company 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.
"We are delighted to acquire the global rights to dinutuximab beta, which is a perfect fit with our strategic focus in the specialty oncology field and will allow us to leverage our commercial infrastructure in the EU and expand our presence in the US," said Lee Morley, EUSA Pharma’s Chief Executive Officer. "Dinutuximab beta is already used extensively across Europe, where it is included in a number of treatment protocols, and we look forward to bringing this life saving therapy to patients around the world. As a rapidly growing specialty pharma company we have made great progress since our launch 18 months ago, and we plan to continue this through further product acquisition and in- licensing."
"EUSA Pharma is the ideal partner to bring dinutuximab beta to market, with its strong focus on oncology and specialty commercial expertise in Europe, the US and further afield," said Dr. Hans Loibner, Apeiron Biologic’s Chief Executive Officer. "Dinutuximab beta is an important treatment in an area of significant unmet need, which we have developed together with our academic partners, in particular with the cooperative group SIOPEN, and we look forward to working with EUSA to make this product available around the world."