COMUNICADO: Global Strategic Partners Merck and Pfizer Finalize Agreement to Co-Promote XALKORI® (crizotinib) (1)

Publicado 07/04/2015 14:01:24CET

DARMSTADT, Germany and NEW YORK, April 7, 2015 /PRNewswire/ --

Not intended for UK-based media


- 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
- Co-promotion of XALKORI allows the Merck-Pfizer alliance to establish a
combined oncology sales organization in key markets for the program

Merck and Pfizer today announced the finalization of the co-promotion agreement allowing the companies to jointly co-promote Pfizer's anaplastic lymphoma kinase (ALK) inhibitor XALKORI(R) (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. The second wave will begin in 2016 and includes China and Turkey.

In 2015, Merck 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.

"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," 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 program to co-develop and co-commercialize avelumab, the co-promotion agreement is an exciting milestone for the alliance between Merck and Pfizer, allowing us to establish our combined oncology sales organization in key markets for the program," said Dr. Andrew Schiermeier, General Manager for the Merck-Pfizer Alliance and Head of Global Oncology, adding: "For Merck, 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 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.

*Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C)

About Non-small Cell Lung Cancer

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[1]. Non-small cell lung cancer is the most common type of lung cancer, accounting for 85 to 90 percent of all lung cancers[2]. Locally advanced and metastatic disease account for approximately 35 to 40 percent[3] and 70 percent[4] of patients, respectively with NSCLC.

About XALKORI(R) (crizotinib)

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. For more information and full prescribing information, please see: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002489/WC500134759.pdf .

Merck-Pfizer Alliance

Immuno-oncology is a top priority for Merck and Pfizer. The global strategic alliance between Merck and Pfizer 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. 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.

Pfizer Inc.: Working together for a healthier world(R)

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at http://www.pfizer.com.

Merck

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