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EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, today announced the acquisition of exclusive global commercialization rights to the oncology product Isqette (dinutuximab beta) from Apeiron Biologics. 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.
Neuroblastoma is an orphan oncology indication with significant unmet medical needs. 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 Isqette, 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 CEO. "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 CEO.
Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company with commercial operations in the US and Europe, and a wider distribution network in approximately 40 further countries. Currently, EUSA has a broad portfolio of approved and named-patient specialty hospital products, which the company has ambitious plans to expand through acquisition and in-licensing. EUSA is supported by significant funding raised from leading life science investor Essex Woodlands.