Social Matters

In the field of social matters, MorphoSys focuses on the following aspects as identified in the materiality analysis: 1) quality of products, 2) access to medicine, 3) innovation in research and development (R&D) and 4) data protection.

Quality of Products

We have a special responsibility to comply with the utmost in quality standards with all processes. We use a Quality Management System (QMS) to ensure the quality of commercial and investigational medicinal products and the integrity and reliability of the data generated. Furthermore, the QMS shall ensure the protection of rights, safety and well-being of clinical trial subjects.

Our integrated QMS complies with the applicable principles of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP) and Good Pharmacovigilance Practice (GVP), commonly referred to as GxP in the following, to control and regulate these processes in our own drug development activities. In doing so, we want to ensure that all development activities follow national and international laws, rules and guidelines. Our independent quality assurance department prepares an annual risk-based audit plan for the objective auditing of contract research organizations, investigational sites, suppliers and contract manufacturers in the GxP area as well as of internal GxP systems and processes.

The Head of Global Quality Assurance reports directly to a member of the Executive Committee. In addition, GMP/GDP status updates are reported and discussed with relevant members of the operational management team as well as the Executive Committee in a Quality Management Review meeting twice a year.

Focus in 2020

MorphoSys conducted audits in 2020 in the GxP area. A certain number of audits from the audit plan 2020 needed to be adjusted due to project-specific requirements, the majority of the remaining audits listed in our audit plan for the reporting year were conducted as planned. Due to COVID-19 pandemic constraints, some of the audits were conducted remotely. For audit findings an action plan was drawn up, and implementation of the measures is regularly reviewed.

The FDA approval and U.S. launch of Monjuvi was one of the key topics also in the field of quality assurance in the reporting year. The quality management system was further developed and adapted accordingly. In addition, inspections in connection with the Biologics License Application (BLA) carried out by the U.S. FDA have been conducted remotely due to the COVID-19 pandemic.

Quality Management System at MorphoSys

Access to Medicine

Ensuring access to our medicines is a critical priority for MorphoSys, and we make considerable investments in developing potential medicines for patients in need. MorphoSys does so without a guarantee of clinical and commercial success, as many products in research and development phases do not achieve market authorization. Sustainable revenues from approved and commercially viable products allow for future investments into our research and development efforts.

At MorphoSys, our philosophy is to responsibly price our medicines by balancing the value of the outcomes and innovation they bring to patients and the healthcare system. There are patients who do not have third-party coverage in several countries of the world. For this reason, access to medicine also involves a social, charitable commitment to help patients without coverage. MorphoSys is dedicated to supporting patients throughout their treatment journeys, and we are working together to help remove patient access barriers. As part of this commitment, MorphoSys believes in offering patient support programs to eligible patients who are prescribed MorphoSys medicines.

The responsible department consists of a global team responsible for setting the strategic direction for value, access and policy across all markets and of a respective team to execute tactics in the U.S. There is a dual structure reporting directly to the Chief Operating Officer as well as to the President of MorphoSys US Inc., with regular updates to the Management Board.

Focus in 2020

Since Monjuvi launched in the third quarter of 2020, MorphoSys and Incyte have co-commercialized the drug in the U.S. As part of the companies’ commitment to supporting patients, the ›› My Mission Support program was set up in the reporting year. My MISSION Support is a robust patient support program offering financial assistance, ongoing education and other resources to eligible patients who are prescribed Monjuvi in the U.S.

In addition to My MISSION Support, the non-profit MorphoSys Foundation has been installed in the U.S. Its main purpose is to provide free product to people who are in need, meet certain eligibility requirements, and also are either uninsured, have insurance that does not cover Monjuvi, or cannot afford the cost-sharing for the drug under policies set by their insurance. Furthermore, the foundation provides charitable grants and donations. In 2020 the foundation helped fund programs to support patients affected by the COVID-19 pandemic. Each program addressed a specific unmet need, including the payment of non-medical bills, provision of psycho-social support or transportation to medical care or treatment.

Before Monjuvi launched, we provided certain patients in the U.S. with access to tafasitamab free of charge through an expanded access program (EAP). In February 2020, we launched this EAP for patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) in the U.S. who are neither treated satisfactorily with an approved drug nor able to participate in a clinical trial. An EAP enables biopharmaceutical companies and physicians to address the unmet medical needs of patients suffering from life-threatening or rare diseases by making innovative medicines available in an ethical and legally compliant manner before their approval.

Innovation in Research and Development (R&D)

Our research and development strategy is focused in areas of high unmet medical need where people’s lives depend on novel and differentiated treatment options. We aim to make a real difference in patients’ lives by focusing on therapeutic areas that best fit our expertise and make the best use of our resources. This includes hematological and solid tumor indications as well as autoimmune diseases. At the core, our Company looks to foster innovation, develop, and deliver high-quality and safe drugs and to make them accessible to patients – a commitment for a sustainable contribution to society’s health.

Our research organization is based in Planegg/Germany. The Head of Research reports directly to the Chief Research & Development Officer (CR&DO) to ensure close exchange and collaboration between research and development.

Focus in 2020

Our focus in 2020 was to position the R&D organization in line with our transition to a fully integrated biopharmaceutical company. This implies a further shift from a focus primarily on technology development to a focus on applying technologies to discover and develop highly differentiated medicines for patients in areas of high unmet need. In the sense of “OneMorphoSys,” all divisions on both sides of the Atlantic work closely together to strengthen the approach of “translational research” – from bench to bedside, but also in a reverse translational sense from bedside to bench. This led to first steps regarding a rejuvenation of our portfolio.

A cross-functional governance body, the Portfolio Innovation Board (PIB) has been installed in the reporting year which builds the platform to elevate and advance key strategic questions. This is a way to collaborate across functions and geographies to connect more nimbly, prioritize key topics, and save time and resources through early alignment that will help to gain speed on behalf of patients.

Information about ongoing clinical trials with our investigational drugs is available on ›› www.clinicaltrials.gov. Our clinical pipeline can be accessed ›› here.

Data Protection

As a biopharmaceutical company, we constantly work with personal data of patients, employees, partners and other stakeholders. The protection of these data is therefore of particular importance. In conjunction with the General Data Protection Regulation of the EU (GDPR) as well as U.S. requirements for the protection and confidential handling of protected health information (PHI), we implemented various procedures to safeguard compliance with these regulations and are continuously working on further improvements. Our team in the U.S. is trained on compliance with the Healthcare Insurance Portability and Accountability Act (HIPAA) and the appropriate use of PHI.

We have appointed an external Data Protection Officer (eDPO) in line with the GDPR and the German Data Protection Act. The eDPO summarizes results in a report that is presented to the Management Board and Supervisory Board once a year. A defined reporting process comes into force immediately in case of suspicious incidents.

Focus in 2020

As a result of the COVID-19 pandemic, related data protection topics came into focus, due to increased remote work, for example. Appropriate measures were taken and implemented, fsuch as the introduction of a remote working policy to ensure compliance with data protection principles and data security during mobile working. To reduce the dependency on face-to-face meetings, we started to develop an e-learning platform to make training accessible also in a remote working area. The rollout is planned for 2021.

In addition, data protection support for the approval and market launch of Monjuvi was a key topic in the reporting year. Here, as well, special challenges arose due to the pandemic situation, for example official inspections had to be carried out virtually. Appropriate measures were taken and the inspections were carried out accordingly.

There were no reportable data protection incidents or corresponding suspicions at MorphoSys AG in 2020.

Data protection via respective IT security measures continued to be a key topic in the reporting year. The Company engaged external security experts to check the technical security controls to detect potential weaknesses. No serious weaknesses were identified. Within the scope of special training and phishing simulations, employees learned about their joint responsibility and essential contribution to IT security in our Company. Our IT and IT security were already very well prepared for the sudden home office situation through the consistent implementation of mobile workplaces and modern infrastructure in previous years. Measures to improve collaboration were selected with a focus on security and additionally secured through integration in Security Information & Event Management (SIEM) and Identity & Access Management System (IAM).

Our internal Computer Emergency Response Team (CERT) has not detected any serious security incidents during the reporting year. Finally, various platforms in the area of Endpoint Detection & Respond (EDR), Cloud Access Security Broker (CASB), Identity & Access Management System (IAM), Security Information & Event Management (SIEM) and Mobile Threat Defense (MTD) were evaluated in order to optimize our cyber defense measures and to ensure data integrity and protection.