MorphoSys AG is further expanding its commercial operations in the US in anticipation of Food and Drug Administration approval of its first wholly-owned antibody therapeutic by the middle of 2020. The product, MOR208, is an Fc-engineered antibody directed against the cancer antigen CD19. It is being developed for diffuse large B cell lymphoma in patients with relapsed disease who are not eligible for high-dose chemotherapy or a stem cell transplant.
During an analyst briefing on 8 May Simon Moroney, the chief executive, said a regulatory submission to the FDA, based on the single-arm L-MIND trial, should be complete by the end of the year. The study is investigating MOR208, whose international nonproprietary name is tafasitamab, with the cancer drug lenalidomide. Based on interim L-MIND data, the FDA gave MOR208 ‘breakthrough therapy’ status in 2017. The company is also in discussions with the European Medicines Agency about using the L-MIND study for a regulatory submission there. The outcome of these talks should be known by late summer, the executive said. In any case, MorphoSys has a second two-arm study underway for regulatory purposes. This was recently amended to incorporate a biomarker capable of identifying best responders.
The MorphoSys subsidiary in the US, which is based in Charlotte, North Carolina, will manage the anticipated MOR108 roll-out as well as sales of any other products that are brought into the portfolio in the future. In February, David Trexler, formerly of EMD Serono, was hired as president. At Serono, which is part of Merck KGaA, he was responsible for the launch of Bavencio, Merck’s checkpoint antibody for Merkel cell carcinoma. Prior to this, he worked at Eisai Inc.
Dr Moroney outlined the commercial plans with the release of the company’s first-quarter results which showed revenue of €13.5 million, up from €2.8 million a year earlier. Turnover was boosted by milestone and estimated royalty payments from Janssen Biotech Inc for Tremfya, a marketed antibody therapeutic which is based on MorphoSys’ technology. Revenue also included a success-based payment from I-Mab Biopharma, a Chinese company which has in-licensed a candidate antibody from MorphoSys for multiple myeloma. Higher spending on research and development and other expenses resulted in a loss of €23.6 million before interest and tax, up from a loss of €19 million the previous year. Cash and cash equivalents however were €431.2 million at the end of the quarter, benefiting from a successful secondary share offering on the US Nasdaq market in 2018.
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