News Feature | December 18, 2014

EMA Backs MorphoSys' Orphan Application For MOR208 In DLCBL

By Estel Grace Masangkay

MorphoSys, a company specializing in developing therapeutic antibodies, announced that it has received the positive opinion of the European Medicines Agency for the Orphan Medicinal Product Designation application of its drug MOR208 as a treatment for diffuse large B-cell lymphoma (DLBCL). The recommendation was also supported by the European Commission.

MOR208 is a therapeutic human monoclonal antibody targeting CD19. MorphoSys is developing the drug for the treatment of B-cell malignancies. It is currently undergoing mid-stage clinical trial for the drug in chronic lymphocytic leukemia (CLL), acute lymphoblastic B-cell leukemia (B-ALL), and non-Hodgkin's lymphoma (NHL).

Dr. Arndt Schottelius, CDO of MorphoSys, said, “2014 was an excellent year for the MOR208 program with a number of advancements. We have gained the orphan drug and orphan medicinal product status for MOR208 for the treatment of DLBCL in addition to the same status in chronic lymphocytic leukemia we announced earlier in the year. We have also received fast track designation in DLBCL and published very promising phase 2 data in DLBCL and other subtypes of NHL at this year's ASH conference. Achieving all of these important regulatory and clinical milestones in 2014 has substantially strengthened this promising cancer program.”

The U.S. Food and Drug Administration (FDA) has earlier granted MorphoSys' MOR208 Orphan Drug Designation in the same indication filed in the EU. Should the drug win approval for its orphan indication, MorphoSys will gain ten years of marketing exclusivity in the EU. Other benefits from the EU's orphan drug designation include tax credits, protocol assistance, and fee waivers for regulatory activities.

Earlier this month, MorphoSys reported positive results from the Phase 2 trial of the drug in relapsed or refractory Non-Hodgkin's Lymphoma (NHL). The results of the study’s initial two stages were presented at the recent 56th Annual Meeting of the American Society of Hematology (ASH).