The following is a brief description of these agreements, which have had, or may have, a significant financial impact on MorphoSys in future years (in alphabetical order).
Astellas Pharma
MorphoSys and Astellas Pharma entered into a license agreement for the use of MorphoSys’s HuCAL technology in March 2007. In February 2008, Astellas decided to extend the current collaboration between the two companies for four more years until 2012.
In July 2008, Astellas exercised a pre-existing option to use MorphoSys’s proprietary RapMAT technology for faster antibody optimization as part of the existing technology transfer agreements between the two companies. As a result, MorphoSys receives annual user fees for the RapMAT technology in addition to user fees for the HuCAL platform.
Bayer HealthCare
The active collaboration with Bayer HealthCare was concluded by the end of 2007. Several therapeutic antibody programs are currently in development and could result in future development-dependent milestone payments and royalties on product sales. Bayer HealthCare is currently evaluating one HuCAL-based program in clinical trials, namely the HuCAL-derived antibody-drug conjugate BAY94-9343 in the therapeutic area of oncology.
Boehringer Ingelheim
The active collaboration with Boehringer Ingelheim was concluded in 2010 but therapeutic programs initiated during the course of the active collaboration continue being developed and may result in future milestone payments and royalties on product sales. In December 2010, Boehringer Ingelheim has filed all necessary documentation to initiate a phase 1 clinical trial with a HuCAL-based antibody. This achievement triggered a clinical milestone payment to MorphoSys.
ContraFect
In April 2011, MorphoSys announced the formation of a new alliance with US-based biotechnology company ContraFect in the discovery and development of therapeutic antibodies for infectious diseases. Under the terms of the five-year agreement, ContraFect will receive access to HuCAL PLATINUM, the latest and most powerful version of MorphoSys's antibody libraries, and AutoCAL at its facility in New York. Payments under the agreement include committed annual license fees in addition to success-based development milestones. MorphoSys also stands to receive royalties on sales of marketed drug products emerging from the collaboration.
ContraFect is a biotechnology company pioneering the use of monoclonal antibodies to treat life-threatening infectious diseases, including MRSA infections and Influenza. ContraFect's scientific approach is based on a transition from conventional mono-therapy to a combinatorial approach using multi-therapy antibody treatment to address the growing challenge of drug resistance and therapy escape mechanisms.
Daiichi Sankyo
In March 2006, MorphoSys and Daiichi Sankyo entered into a license agreement and therapeutic antibody collaboration for an initial two-year term with the option of an extension of up to three more years. In March 2008, the collaboration was extended until March 2011.
In October 2009, MorphoSys announced an additional agreement with Daiichi Sankyo in the discovery and development of therapeutic antibodies for hospital-acquired infections. Daiichi Sankyo became MorphoSys’s first collaborator for HuCAL PLATINUM-based drug discovery in infectious diseases. Daiichi Sankyo also agreed to fund the development of certain infectious disease-specific technologies at MorphoSys which will be used to identify the most effective antibody-based drugs.
GeneFrontier / Kaneka
Under the terms of a therapeutic target sourcing collaboration signed in 2007, GeneFrontier may utilize MorphoSys’s HuCAL GOLD antibody library to generate novel HuCAL antibodies against targets provided by leading Japanese research institutes and universities. For this purpose, the HuCAL antibody technology was installed at GeneFrontier’s research laboratories within a research facility in Tokyo. GeneFrontier pays compensation for access to HuCAL GOLD.
Janssen Biotech
The active collaboration with Janssen Biotech (formerly Centocor Ortho Biotech), a wholly owned subsidiary of US pharmaceutical company Johnson & Johnson, was concluded by the end of 2007. Several therapeutic antibody programs are currently in development and could result in future development-dependent milestone payments and royalties on product sales. The most advanced compounds within this collaboration are in phase 2 clinical trials. CNTO888, is currently in a phase 2 clinical trial in an immunology indication and in a second phase 2 clinical trial in oncology patients. CNTO 1959 is currently in a phase 2 clinical trial in psoriasis. Two additional programs are being evaluated in phase 1 clinical trials, namely CNTO3157, in the therapeutic area of asthma, and an undisclosed program. In total, Janssen Biotech is currently evaluating five HuCAL-based programs in clinical trials.
Merck & Co.
In December 2005, MorphoSys signed a five-year license agreement with US pharmaceutical company Merck & Co., Inc. for the use of MorphoSys’s HuCAL GOLD and AutoCAL technologies in research and development of human therapeutic antibodies. The agreement enables Merck to develop up to ten HuCAL-derived therapeutic antibodies in a range of indications. The active collaboration was concluded, as planned, at the end of 2010.
In May 2006, MorphoSys and Schering-Plough signed a license agreement for the use of MorphoSys’s HuCAL GOLD technology in the research and development of human therapeutic antibodies. Schering Plough was acquired by Merck during the course of 2009. The active collaboration was concluded, as planned, in mid 2011.
Novartis
MorphoSys and Novartis started working together in 2004 in a collaboration that has so far resulted in multiple active therapeutic antibody programs across various diseases and the first IND filing in September 2007 — just three years after initiation. In December 2007, MorphoSys and Novartis substantially extended their previous relationship and forged one of the most comprehensive strategic alliances in the discovery and development of biopharmaceuticals. Based on a ten-year term, committed annual payments total more than US$ 600 million in technology access, internalization fees and R&D funding, excluding reimbursement of R&D costs related to early-stage development activities. Total payments under the agreement, including committed payments and probability-weighted success-based milestones, contingent upon successful clinical development and market approval of multiple products, could potentially exceed US$ 1 billion, assuming the collaboration successfully runs its maximum term. In addition to these payments, MorphoSys would also be entitled to royalty payments and/or profit sharing on any future product sales. Additionally, MorphoSys also has options to participate in certain development activities in various programs, with part of the early-stage costs being funded by Novartis. Under the codevelopment options, MorphoSys may elect to participate in these projects through cost and profit-sharing with financial participation reflecting its level of investment in the respective programs.
In 2009, Novartis committed to a ten-year term of the strategic alliance. The decision was based on MorphoSys’s successful achievement of certain predefined improvements in its proprietary technologies. The collaboration will run until 2017 and may be extended by Novartis for an additional two years beyond that time under the same financial terms and conditions. Three compounds within this collaboration, namely BHQ880 against cancer, BYM338 against musculoskeletal diseases and another program are currently in phase 2 clinical trials. In total, Novartis is currently evaluating five HuCAL-based programs in clinical trials.
OncoMed Pharmaceuticals
The active collaboration with US-based biopharmaceutical company OncoMed Pharmaceuticals was concluded in 2010 but therapeutic programs initiated during the course of the active collaboration can continue development and result in future milestone payments and royalties on product sales. In December 2010, OncoMed has filed all necessary documentation to initiate a phase 1 clinical trial with a HuCAL-based cancer antibody, namely OMP-59R5. In April 2011, MorphoSys announced that it had received a second clinical milestone with OncoMed. The antibody OMP-18R5, which targets the Wnt signaling pathway, will be evaluated in a Phase 1 trial in the US in patients with advanced solid tumors.
Pfizer
The active collaboration with Pfizer based on the HuCAL technology platform was concluded in 2010 but therapeutic programs initiated during the course of the active collaboration can continue development and result in future milestone payments and royalties on product sales. In December 2010, Pfizer has filed all necessary documentation to initiate a phase 1 clinical trial with a HuCAL-based antibody. This achievement triggered a clinical milestone to MorphoSys.
Additionally, MorphoSys and Pfizer signed a non-exclusive license and technology transfer agreement based on a new technology platform in 2010. The agreement covers the installation, training and use of the technology platform Slonomics for the fabrication of highly-diverse gene and protein libraries at Pfizer’s subsidiary Rinat Neuroscience Corp. in South San Francisco. MorphoSys’s subsidiary Sloning BioTechnology GmbH received an upfront payment and stands to receive annual license fees over the patent lifetime of the Slonomics technology platform. MorphoSys acquired Sloning BioTechnology GmbH and its technology portfolio including Slonomics in October 2010.
ProChon Biotech
The active collaboration with ProChon Biotech was concluded but therapeutic programs initiated during the course of the active collaboration can continue development and result in future milestone payments and royalties on product sales. Under the original agreement, MorphoSys applied its innovative HuCAL antibody library to generate human antibodies against a human growth factor receptor associated with various skeletal disorders including achondroplasia, the most common form of human dwarfism, and certain cancers.
Roche
In September 2000, MorphoSys and Roche announced the signing of an agreement under which the companies collaborate on the development of human therapeutic antibodies for a Roche biological target associated with Alzheimer’s disease. In the context of the collaboration, MorphoSys is eligible to receive development-related milestone payments and royalties on any marketed products emerging from the collaboration. A phase 1 clinical trial program to evaluate safety and tolerability of the HuCAL-derived antibody program Gantenerumab in Alzheimer’s disease patients was operationally concluded by Roche in 2009. In November 2010, Roche advanced this compound into phase 2 clinical trials.
Expanding on the relationship in Alzheimer’s disease, MorphoSys and Roche announced a new collaboration to develop new therapeutic antibodies in oncology in March 2006.
