MorphoSys AG and Incyte Corporation have inked a collaboration and license deal to further develop and commercialize MorphoSys’ anti-CD19 antibody tafasitamab around the world. Tafasitimab is a humanized Fc-engineered monoclonal antibody against CD19, which MorphoSys licensed from Xencor in 2010. It is being evaluated in B-cell malignancies in several ongoing combination trials.
The two companies will co-commercialize the drug in the U.S. and Incyte will market it outside of the U.S. Under the terms of the deal, Incyte will pay MorphoSys $750 million up front. It will also make an equity investment into MorphoSys of $150 million in American Depositary Shares (ADS) at a premium to the share price.
The deal could hit up to $1.1 billion based on various developmental, regulatory and commercial milestones. MorphoSys is also eligible for tiered royalties on U.S. net sales of tafasitamab outside the U.S. in the mid-teens to mid-twenties percentage range.
“The global partnership with Incyte is an important step towards unlocking the full potential of tafasitamab and achieving our goal of rapidly bringing tafasitamab to patients inside and outside the U.S.,” said Jean-Paul Kress, MorphoSys’ chief executive officer.
Kress added, “The combination of our strong antibody and drug development expertise partnered with Incyte’s well-established hematology-oncology experience and their commercial operations in key territories has the potential to significantly broaden the tafasitamab opportunity. We are pleased to work with Incyte to jointly improve the lives of patients suffering from DLBCL and other devastating diseases.”
The two companies will co-develop the drug in relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL), frontline DLBCL and in other indications such as follicular lymphoma (FL), marginal zone lymphoma (MZL) and chronic lymphocytic leukemia (CLL). Incyte will initiate a combination trial of its PI3K-delta inhibitor parsaclisib and tafasitamab in r/r B-cell malignancies. Incyte will also handle any potential registration-enabling studies in CLL and a Phase III study in r/r FL/MZL.
MorphoSys will continue to run it ongoing clinical trials of tafasitamab in non-Hodgkin lymphoma (NHL), CLL, r/r DLBCL and frontline DLBCL. They will split responsibilities for any additional global trials. Incyte also plans to work on development in other territories including Japan and China.
Morphosys recently submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tafasitamab in combination with lenalidomide for r/r DLBCL. The target action date is mid-2020. It is also planning a similar application to the European Medicines Agency (EMA) for mid-2020.
“Bringing together Incyte’s expertise and MorphoSys’ commitment to innovation will allow us to make tafasitamab widely available to patients with cancer, upon approval,” said Herve Hoppenot, chief executive officer of Incyte. “We look forward to collaborating closely with the team at MorphoSys and adding tafasitamab to our portfolio of oncology candidates as part of our commitment to bringing new, advanced treatment options to patients and the clinical community around the world.”
