Date: 2016-11-08
Type of information: Development agreement
Compound: Mabion CD20 (biosimilar version of Mabthera®/Rituxan® - rituximab)
Company: Mylan (USA - PA) Mabion (Poland)
Therapeutic area: Cancer - Oncology
Type agreement: development commercialisation
Action mechanism: biosimilar/monoclonal antibody. Mabion CD20 is a biosimilar version of Mabthera®/Rituxan® - rituximab. Rituximabt binds to the CD20 antigen on the surface of normal and malignant B-cells and then recruits the body’s natural defenses to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
Disease:
Details: * On November 8, 2016, Mabion announced that the company has signed a long-term development and commercialization agreement with Mylan Ireland. The agreement gives Mylan exclusive rights to sell Mabion’s biosimilar of Mabthera/Rituximab (Mabion CD20) in all EU countries and non EU Balkan states. Mylan will support Mabion in Mabion’s effort to secure approval of Mabion CD20 by the European Medicine Agency. Plexus Ventures, a global pharmaceutical business development firm, advised Mabion S.A. on this transaction.
Financial terms: Under the terms of the agreement and subject to certain conditions, Mylan will pay Mabion an upfront payment of US$10 million and additional milestone payments in the aggregate of up to US$35 million subject to filing and approval of marketing authorizations and commercial launch in key countries, as well as royalties based on annual net sales.
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