PLANEGG, Germany & WILMINGTON, Del.—Looking to push forward MorphoSys AG’s proprietary anti-CD19 antibody tafasitamab (MOR208) globally, MorphoSys and Incyte Corp. announced in January that they had entered into a collaboration and license agreement to further develop and commercialize the Fc-engineered antibody against CD19, which is currently in clinical development for the treatment of B cell malignancies.
“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 of the U.S.,” said Dr. Jean-Paul Kress, CEO of MorphoSys. Under the terms of the deal, MorphoSys and Incyte will co-commercialize tafasitamab in the United States, while Incyte has exclusive commercialization rights outside of the country.
Continued Kress: “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 [diffuse large B-cell lymphoma] and other devastating diseases.”
Under the terms of the agreement, MorphoSys will receive an upfront payment of $750 million and, in addition, Incyte will make an equity investment into MorphoSys of $150 million in new American Depositary Shares of MorphoSys at a premium to the share price at signing of the agreement. Depending on the achievement of certain developmental, regulatory and commercial milestones, MorphoSys will be eligible to receive milestone payments amounting to up to $1.1 billion. MorphoSys will also receive tiered royalties on net sales of tafasitamab outside of the United Sates in a mid-teens to mid-twenties percentage range of net sales.
“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 Hervé Hoppenot, CEO 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.”
Both parties have agreed to co-develop tafasitamab broadly in relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL), frontline DLBCL and additional indications beyond DLBCL, such as follicular lymphoma (FL), marginal zone lymphoma (MZL) and chronic lymphocytic leukemia (CLL).
Incyte will be responsible for initiating a combination study of its investigational PI3K-delta inhibitor parsaclisib and tafasitamab in r/r B cell malignancies. Further, Incyte will be responsible for leading any potential registration-enabling studies in CLL and a Phase 3 trial in r/r FL/MZL. MorphoSys will continue to be responsible for its currently ongoing clinical trials of tafasitamab in non-Hodgkin lymphoma, CLL, r/r DLBCL and frontline DLBCL. The parties will share responsibility in starting additional global trials, and Incyte intends to pursue development in additional territories including Japan and China.
MorphoSys recently submitted a Biologics License Application to the U.S. Food and Drug Administration for tafasitamab in combination with lenalidomide for the treatment of r/r DLBCL, and the FDA decision regarding a potential approval is expected by the middle of this year. The submission of a Marketing Authorization Application to the European Medicines Agency in r/r DLBCL is planned for mid-2020.
Via the online publication Vantage, Jacob Plieth of pharma anlaysis firm Evaluate wrote, “It’s probably fair to say that biotech investors hungry for deals at the start of this week’s JP Morgan healthcare jamboree were expecting something bigger than Lilly’s buyout of Dermira and the licensing deal Incyte struck today for Morphosys’ tafasitamab, [but the MorphoSys-Incyte] deal is not to be sniffed at. It represents the joint fifth-biggest single-project licensing transaction by up-front value—$750m—of recent times, and is an amazingly strong endorsement of an asset that still has a lot left to prove.”
FierceBiotech writer Nick Paul Taylor echoed some of those sentiments by noting, “The range of therapeutic and geographic opportunities—Incyte highlighted China and Japan as new markets it wants to target—creates the potential for tafasitamab to be a significant product. For that to happen, tafasitamab needs to back up the promise it has shown to date with impressive data in studies with control arms.”