Date: 2015-04-07
Type of information: Development agreement
Compound: avelumab (MSB0010718C) , Xalkori® (crizotinib), anti-PD-1 antibody
Company: Pfizer (USA - NY) Merck Serono, a Merck KGaA company (Germany)
Therapeutic area: Cancer - Oncology
Type agreement: development commercialisation co-promotion
Action mechanism: monoclonal antibody/immune checkpoint inhibitor/kinase inhibitor. MSB0010718C (avelumab) is a fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses and inhibits tumor growth. Xalkori® (crizotinib) is a kinase inhibitor indicated in the U.S. 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 FDA-approved test. The U.S. indication is not limited to any specific line of therapy. In the EU, the drug is indicated for the treatment of adults with previously treated ALK-positive advanced NSCLC. It has received approval in more than 75 countries including Australia, Canada, China, Japan, South Korea and the European Union.
Disease: multiple types of cancer
Details: * On November 17, 2014, Pfizer announced that it 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 novel anti-PD-L1 antibody as a single agent as well as in various combinations with Pfizer’s and Merck KGaA’s broad portfolio of approved and investigational oncology therapies. Building on the ongoing Phase 1 program that has treated more than 550 patients, both companies will collaborate on up to 20 high priority immuno-oncology clinical development programs expected to commence in 2015. These clinical development programs include up to six trials (Phase 2 or 3) 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 1 trial, more than 550 patients have been treated with MSB0010718C across multiple types of cancers. As part of the Analyst and Investor Day hosted by Merck KGaA on September 18, 2014, interim data were presented from an ongoing Phase 1 study demonstrating a complete response and partial responses in patients with non-small cell lung cancer and ovarian cancer. Additional data are expected to be presented at medical congresses in 2015. There is also an ongoing Phase 2 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 1 trials. The parties have also agreed to co-promote Pfizer’s Xalkori® in the United States and several other key markets.
Financial terms: 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. As a result of this transaction, Pfizer will recognize this upfront payment as a certain significant item which will impact Reported Diluted earnings per share or EPS. Pfizer is updating its previous 2014 Reported Diluted EPS guidance range from $1.50 - $1.59 to $1.40 - $1.49, while maintaining the other elements of its 2014 financial guidance.
Latest news: * On April 7, 2015, Merck KGaA and Pfizer have finalized agreements to co-promote Xalkori® (crizotinib). In the second and third quarters of 2015, Merck and Pfizer will begin co-promoting Xalkori® in the United States, Canada, Japan and five European Union countries (France, Germany, Italy, Spain and the United Kingdom). In the United States and Canada, Xalkori® will be co-promoted by EMD Serono, the US and Canadian biopharmaceutical businesses of Merck KGaA. Co-promotion of Xalkori® allows the Merck-Pfizer alliance to establish a combined oncology sales organization in key markets for the program. The second wave will begin in 2016 and includes China and Turkey. In 2015, Merck KGaA will receive a reimbursement associated with its promotion of Xalkori®, followed by an 80 percent (Pfizer), 20 percent (Merck) profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the United States, Canada, Japan, France, Germany, Italy, Spain and the United Kingdom and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of Xalkori® in countries where it is co-promoted with Merck. This co-promotion relationship is related to the announcement in November 2014 of a global strategic alliance between Merck and Pfizer to jointly develop and commercialize avelumab, an investigational anti-PD-L1 monoclonal antibody, to accelerate the development of immuno-oncology medicines for patients with cancer. The immuno-oncology alliance will also advance Pfizer's PD-1 antibody.
