Focus in 2020
With the accelerated approval of Monjuvi by the U.S. Food and Drug Administration (FDA), our first proprietary drug, in July 2020, MorphoSys became a fully integrated biopharmaceutical company. The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study (MOR208C203), an open label, multicenter, single-arm trial of Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
Receiving approval based on a single-arm study without a comparator arm required highly innovative approaches to drive clinical development. The contribution of tafasitamab to the activity of the combination was supported by the efficacy of tafasitamab monotherapy in an r/r DLBCL cohort from the MOR208C201 study. With regards to the activity of lenalidomide, MorphoSys chose to follow a real world data approach via an observational retrospective study (MOR208C206, RE-MIND). The study was designed to characterize the effectiveness of lenalidomide monotherapy in the treatment of r/r DLBCL and to compare the effectiveness of lenalidomide monotherapy with the efficacy outcomes with tafasitamab + lenalidomide therapy. The efficacy data of the L-MIND trial was considered by the authorities in the context of results observed in the RE-MIND study and literature reports regarding the activity of single agent lenalidomide.
Due to the global COVID-19 pandemic, MorphoSys took a variety of factors into consideration, such as a potential adaptation of clinical trials due to restrictions on visits to healthcare facilities, increased demands on healthcare services and changes in the availability of study personnel. MorphoSys continuously monitored the situation and took appropriate decisions on a case-by-case basis to ensure the safety of patients, study personnel and other stakeholders, as well as to safeguard data integrity.
Patient enrollment for all ongoing tafasitamab studies in the reporting year continued as planned. Patients with DLBCL suffer from a life-threatening disease that requires treatment and usually does not allow a delay in therapy. However, a potential delay in recruitment cannot be ruled out due to the factors mentioned above.
Patient enrollment for the M-PLACE study with felzartamab (MOR202), which had been temporarily paused due to the COVID-19 pandemic, was resumed in the second quarter of 2020.
Selling Practices and Labeling
The FDA approval and U.S. launch of Monjuvi was a milestone in the reporting year. In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize the drug globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the U.S. Incyte has exclusive commercialization rights outside the U.S.
The Monjuvi launch also brought anticipated changes in the organizational structure of MorphoSys, including the implementation of completely new functions and departments along the Company’s value chain.
In particular, marketing and sales structures had to be established starting in 2019 – a process that has continued throughout 2020. By building up a highly qualified team of experts, we wanted to ensure that we meet all relevant standards of business ethics and compliance.
To adhere to good commercial practice, Review Committees (RCs) have been established to review and approve all commercial materials and tactics. An internal RC focuses on MorphoSys materials only, a second joint RC is set up together with our partner Incyte and consists of representatives of both companies focusing on reviewing and approving joint materials and activities. Any sales and marketing materials must be reviewed and approved by the RCs prior to submission to the health authorities.
The formal training of our sales representatives is a cornerstone of our strategy when it comes to business ethics and compliance in this field. Each representative undergoes detailed training on the product and disease state. Successful certification is required before they can begin to engage with healthcare professionals. A learning management system tracks training progress and certification. In addition, our sales representatives are trained in all relevant compliance and legal policies by the MorphoSys compliance and legal teams.
Regarding product labeling, the balance of benefit and risk is always displayed in any promotional materials. As this is the main information that can be shared with prescribers, we attach great importance to ensure that all relevant information is included in all promotional materials to achieve the highest quality standards.
Focus in 2020
Our focus in 2020 was the ongoing refinement of the organizational structures as outlined above. Training courses for sales representatives were conducted and their progress was monitored. The measures implemented in the reporting year support us on our growth path as a commercial-stage biopharmaceutical company.