Pfizer, Merck KGaA Form Potential $2.9 Billion Immuno-Oncology PactBy
Pfizer has entered into an agreement with Merck KGaA to jointly develop and commercialize MSB0010718C, an investigational anti-PD-L1 antibody currently in development by Merck KGaA as a potential treatment for multiple types of cancer. Pfizer and Merck KGaA will explore the therapeutic potential of this anti-PD-L1 antibody as a single agent as well as in various combinations with Pfizer's and Merck KGaA's portfolio of approved and investigational oncology therapies.
Both companies will collaborate on up to 20 high priority immuno-oncology clinical development programs expected to begin in 2015. These clinical development programs include up to six trials (Phase II or III) that could be pivotal for potential product registrations.
There are currently two clinical development programs underway evaluating Merck KGaA's anti-PD-L1 antibody. In a Phase I trial, more than 550 patients have been treated with MSB0010718C across multiple types of cancers. There is also an ongoing Phase II trial evaluating this antibody in patients with metastatic Merkel cell carcinoma, a rare form of skin cancer.
Separate from the PD-L1 programs, Pfizer and Merck KGaA will also combine resources and expertise to advance Pfizer's anti-PD-1 antibody into Phase I trials. The parties have also agreed to co-promote Pfizer's Xalkori (crizotinib) in the United States and several other key markets. Xalkori is a kinase inhibitor indicated in the US for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an US Food and Drug Administration-approved test. The US indication is not limited to any specific line of therapy. In the EU, Xalkori is indicated for the treatment of adults with previously treated ALK-positive advanced NSCLC. Xalkori has received approval in more than 75 countries, including Australia, Canada, China, Japan, South Korea and the European Union.
Under the terms of the agreement, Merck KGaA will receive an upfront payment of $850 million and is eligible to receive regulatory and commercial milestone payments up to approximately $2 billion. Both companies will jointly fund all development and commercialization costs, and all revenues obtained from selling any anti-PD-L1 or anti-PD-1 products generated from this collaboration will be shared equally.
Pfizer is working to advance the science in immuno-oncology and is actively exploring a variety of novel agents, including checkpoint modulating antibodies, CAR-T therapies, bi-functional monoclonal antibodies, and vaccine-based immunotherapy regimens. Pfizer's 4-1BB agonist antibody is currently in Phase I, with several other immunotherapeutic agents expected to begin clinical testing in 2015, including a monoclonal antibody against receptor, OX40 (CD134); a PD-1 monoclonal antibody; and a vaccine-based regimen for prostate cancer. Pfizer is exploring the potential of combining immunotherapies with its oncology portfolio through the company's own development efforts as well as in collaboration with other partners.