Jan 13, 2020: MorphoSys AG and Incyte Corporation  announced that the companies have entered into a collaboration and license agreement to further develop and commercialise MorphoSys’ proprietary anti-CD19 antibody tafasitamab (MOR208) globally.
Tafasitamab is an Fc-engineered antibody against CD19 currently in clinical development for the treatment of the B cell malignancies.
Both will co-commercialise tafasitamab in the US, while Incyte has exclusive commercialisation rights outside of the US.In the US, MorphoSys and Incyte will co-commercialize tafasitamab, with the MorphoSys leading the commercialization strategy and booking all the revenues from sales of tafasitamab.
They will be collectively responsible for commercialization activities in the US and will share profits and losses on a 50:50 basis.
Outside the US, Incyte will have exclusive commercialization rights, and will lead the commercialisation strategy and book all revenues from sales of tafasitamab, paying MorphoSys royalties on ex-US net sales.
Additionally, the companies will share development costs associated with global and US-specific trials at a rate of 55% (Incyte) to 45% (MorphoSys); Incyte will cover over 100% of the potential development costs for trials that are specific to ex-U.S. countries.
Both parties have agreed to co-develop tafasitamab broadly in relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL), frontline DLBCL as well as additional indications beyond the DLBCL, such as the follicular lymphoma (FL), marginal zone lymphoma (MZL) and chronic lymphocytic leukemia (CLL).
MorphoSys recently submitted a Biologics License Application (BLA) for tafasitamab, in combination with lenalidomide, to the US Food and Drug Administration (FDA) for the treatment of r/r DLBCL; the FDA decision regarding a probable approval is expected by mid-2020.
The submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in r/r DLBCL is planned for the mid-2020. https://www.morphosys.com/media-investors/media-center/morphosys-and-incyte-sign-global-collaboration-and-license-agreement
