MARTINSRIED & MUNICH, Germany—MorphoSys AG announced today that it has regained rights to MOR202 from Celgene Corporation. The companies have mutually agreed to terminate their co-development and co-promotion agreement for MOR202. Clinical development of MOR202, which currently involves a MorphoSys-sponsored Phase 1/2a trial in relapsed or refractory multiple myeloma patients, will continue as planned. This trial includes combination cohorts with lenalidomide and pomalidomide which will be provided to MorphoSys by Celgene. Financial details were not disclosed.
"Regaining rights to MOR202 opens up new possibilities for MorphoSys," commented Dr. Simon Moroney, CEO of MorphoSys, in a statement. "MOR202 binds to CD38, a clinically validated target in multiple myeloma, and we know there is a lot of interest in the program. We thank Celgene for working with MorphoSys to advance the clinical development of MOR202. This program is a valuable component of our proprietary portfolio, and we are looking forward to presenting clinical data in the near future."
"We are committed to continuing the development of MOR202 as there is a high unmet medical need for new treatment options in multiple myeloma," added Dr. Arndt Schottelius, chief development officer of MorphoSys AG. "Based on pre-clinical data, we see significant promise in combining MOR202 with Celgene's lenalidomide and pomalidomide in clinical trials which will commence soon." MorphoSys aims to release first clinical data from the ongoing phase 1/2a trial at a medical conference in 2015. Cohorts in which MOR202 is combined with lenalidomide and with pomalidomide will be added to the trial during the first half of 2015. CD38 is a promising target for the treatment of multiple myeloma and potentially other hematological malignancies. An effective antibody against this target could change future treatment regimens in multiple myeloma and also become the basis for treatments in several other forms of cancer.
As a result of the termination of the co-development and co-promotion agreement for MOR202, MorphoSys has updated its financial guidance. The company now expects revenues for the 2015 financial year in the amount of €101 million to €106 million (up from previously €58 million to €63 million) due to the full realization of deferred revenues from the original agreement with Celgene and a one-time payment from Celgene for development costs in 2015. Based on management's current planning, proprietary R&D expenses are expected to increase to a range of €56 million to €63 million (previously €48 million to €58 million), including the development costs for MOR202 for the remainder of the year. The company now expects earnings before interest and taxes (EBIT) of approximately €9 million to €16 million in 2015 (previously €20 million to €30 million).
MorphoSys developed HuCAL, which it claims is 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. Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 90 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow.
With its core platform technologies—HuCAL, Ylanthia and Slonomics—MorphoSys has delivered what it believes is the gold standard of antibody generation and optimization in the industry. A set of auxiliary technology modules has been established to exploit the full potential of these core systems. Novel technology platforms are in development including a therapeutic peptide library based on lanthipeptides. “It is noteworthy,” the company states on it website, “that MorphoSys’s current success rate from target to qualified antibody candidates is >95%. More than one in five of the programs we start progresses from antibody generation to the clinic.”