NEW YORK—Merck KGaA and Pfizer Inc. have finalized a co-promotion agreement by which the organizations will co-promote Pfizer's XALKORI, an anaplastic lymphoma kinase (ALK) inhibitor.
The agreement stipulates that XALKORI will be co-promoted in two waves. The first wave will begin in the second and third quarters of this year in the United States, Canada, Japan, the United Kingdom, France, Germany, Italy and Spain. EMD Serono, the U.S. and Canadian biopharmaceutical businesses of Merck KGaA, will co-promote the drug in the United States and Canada. The second wave includes China and Turkey, and will begin next year. Sometime this year, Merck will receive a reimbursement associated with its promotion of XALKORI, and in 2016, Pfizer and Merck will begin a profit sharing plan for the product, with Pfizer receiving 80 percent and Merck 20 percent. This co-promotion is slated to run through Dec. 31, 2020, in the United States, Canada, Japan, France, Germany, Italy, Spain and the United Kingdom, and from Jan. 1, 2016, through Dec. 31, 2021, in China and Turkey. Pfizer will report all XALKORI sales in the countries in which it is co-promoting the drug with Merck.
“As we progress our robust program 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,” Dr. Andrew Schiermeier, head of Global Oncology and general manager for the Alliance for Merck KGaA, Darmstadt, Germany, said in a press release. “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.”
“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. 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,” Liz Barrett, president and general manager of Pfizer Oncology, commented in a press release.
XALKORI is the first ALK inhibitor to be approved in the United States, the European Union and Japan, and is indicated for the treatment of non-small cell lung cancer (NSCLC), with support from two positive, global, randomized trials in the first- and second-line ALK-positive advanced NSCLC treatment settings.
This agreement is related to the global strategic alliance announced by Merck and Pfizer in November 2014, in which the companies agreed to jointly develop and commercialize avelumab, an investigational anti-PD-L1 monoclonal antibody. (To read up on that deal, check out “Potential $2-billion deal teams Pfizer and Merck KGaA on immune-oncology.”)
SOURCE: Pfizer press release