Pfizer and Merck KGaA, Darmstadt, Germany announced the finalization of the co-promotion agreement allowing the companies to co-promote Pfizer’s anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib). This agreement showcases the alliance’s commitment to establishing a combined oncology sales organization in key markets in advance of the potential launch of avelumab-based treatment regimens in the future.
Xalkori is the first ALK inhibitor approved in the United States, Japan and the European Union (EU) and is supported by two positive global randomized trials in the first- and second-line ALK-positive advanced non-small cell lung cancer (NSCLC) treatment settings. To date, globally more than 8,000 patients have been treated with Xalkori, including those who received Xalkori in clinical trials.
Under the agreement, Xalkori will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 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, Darmstadt, Germany. The second wave will begin in 2016 and includes China and Turkey.
In 2015, Merck KGaA, Darmstadt, Germany, will receive a reimbursement associated with its promotion of Xalkori, followed by an 80 per cent (Pfizer), 20 per cent (Merck KGaA, Darmstadt, Germany) 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 KGaA, Darmstadt, Germany.
"We are proud and excited to share the legacy of Xalkori, a medicine that changed the treatment paradigm for patients with ALK-positive metastatic NSCLC, with Merck KGaA, Darmstadt, Germany,” said Liz Barrett, president and general manager, Pfizer Oncology. “Through our co-promotion of Xalkori, we will establish a best-in-class global sales organization that will be exceptionally prepared for the potential launches of our future oncology medicines.”
“As we progress our robust programme to co-develop and co-commercialize avelumab, the co-promotion agreement is an exciting milestone for the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer, allowing us to establish our combined oncology sales organization in key markets for the program,” said Dr. Andrew Schiermeier, head of Global Oncology and general manager for the Alliance for Merck KGaA, Darmstadt, Germany, adding: “For Merck KGaA, Darmstadt, Germany, this agreement is particularly important as it accelerates the establishment of our United States and Canada oncology sales organization ahead of our potential avelumab launches and positions us for future success in this market.”
This co-promotion relationship is related to the announcement in November 2014 of a global strategic alliance between Merck KGaA, Darmstadt, Germany, 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.
Globally, lung cancer is the most common cause of cancer-related deaths in men and the second most common in women, responsible for almost twice as many deaths as both breast and prostate cancer combined. Non-small cell lung cancer is the most common type of lung cancer, accounting for 85 to 90 per cent of all lung cancers. Locally advanced and metastatic disease account for approximately 35 to 40 per cent3 and 70 per cent4 of patients, respectively with NSCLC.
Xalkori is a kinase inhibitor indicated in the US for the treatment of patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-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 80 countries.
Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc, New York, US, enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an investigational anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1 antibody. The companies will collaborate on up to 20 high priority immuno-oncology clinical development programs, including combination trials, many of which are expected to commence in 2015.