MorphoSys AG has received a positive opinion from the European Medicines Agency (EMA) on the application for orphan medicinal product designation for MOR208, MorphoSys' humanized Fc engineered monoclonal antibody against CD19, for the treatment of diffuse large B-cell lymphoma (DLBCL). The positive opinion is to be adopted by the European Commission. Earlier in December the Company had also received the orphan drug designation by the Food & Drug Administration for MOR208 in the same indication.
"2014 was an excellent year for the MOR208 programme 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," commented Dr. Arndt Schottelius, chief development officer of MorphoSys AG.
Orphan drug and orphan medicinal product status are granted by the US and European health authorities respectively to promote the development of promising therapeutics for the treatment of rare diseases affecting fewer than 200,000 people in the US annually and no more than five in 10,000 people in the European Union. Orphan drug designation includes benefits such as a seven-year period of marketing exclusivity in the United States and ten years of market exclusivity in the European Union after approval. Other potential advantages come in the form of protocol assistance, the ability to apply for research funding, tax credits for certain research expenses, and fee waivers for the regulatory procedures.
DLBCL is the most common lymphoma and accounts for approximately 25 per cent of all NHLs in the developed world. The disease occurs primarily in older individuals, though it can also occur in children and young adults in rare cases.
MOR208 is an Fc-enhanced, humanized monoclonal antibody targeting the antigen CD19, which is being developed for the treatment of B-cell malignancies. The program is currently in phase 2 clinical development in chronic lymphocytic leukemia (CLL), acute lymphoblastic B-cell leukemia (B-ALL) and non-Hodgkin's lymphoma (NHL).
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.