MorphoSys AG (NASDAQ:MOR) Q1 2020 Earnings Conference Call - Final Transcript
May 07, 2020 • 08:00 am ET
two months now, and it is going very well. Incyte established global hematology/oncology presence and their track record in commercializing important new medicines are highly complementary to our strength, including our antibody and drug development expertise.
Since the official closing of the deal, we have been aligning on launch activities and development plans. Together, we will maximize the full potential of tafasitamab. We plan to share more details on this later this year. Also during the first quarter, our BLA for tafasitamab was granted priority review by the FDA and given the PDUFA date of August 30. The FDA has indicated that currently no advisory committee meeting is planned. While waiting for the FDA decision on the BLA filing, we also wanted to provide access to tafasitamab to patients who have no other treatment options. Therefore, we initiated an expanded access program in the U.S. in February. This EAP allows us to make tafasitamab available to eligible patients with relapsed or refractory diffuse large B-cell lymphoma, who are not eligible for available clinical trials and do not have other treatment options. One of my goals has been to strengthen the executive team, and I am very pleased to welcome Roland Wandeler as our new Chief Commercial Officer. Roland brings a wealth of leadership experience, a clear focus on customer and patient needs and a track record of exceptional execution, both in the U.S. and internationally. Roland will lead our global commercial operations, and will oversee our planned U.S. launch for tafasitamab. Roland just started this week, and I look forward to introducing him to you during a future call.
Turning now to our development activities highlights. I already mentioned the acceptance of the BLA for tafasitamab. All ongoing tafasitamab trials currently continue, and we have not experienced any major disruptions from COVID-19 in those trials. In general, we see positive signals from sites and investigators, and we see high interest in the ongoing trials. First-MIND, our trial in frontline DLBCL patients, is proceeding well and will be the basis for our pivotal trial that we plan to start next year. We are also finalizing our plans to develop tafasitamab in additional indications and with different combination partners. For instance, we noticed encouraging clinical data in CLL for the combination of T-cell depleting antibodies with PI3 kinase inhibitors, and we plan to look into such combinations as well. As seen with many compounds in development in immunology and inflammation, the recruitment of patients was proactively paused for MOR202 in autoimmune indications, and for Otilimab, which is in Phase III development for RA by GSK. However, for some countries, especially in Europe, we see that the situation is improving and some restrictions are being lifted. So we continue to watch the situation carefully and are fully prepared to restart our trial as soon as circumstances permit.
For the development of MOR202 in oncology, we were very pleased to see that our partner I-Mab dosed the first patient in Mainland, China in the