Global Strategic Partners Merck and Pfizer Finalize Agreement to Co-Promote XALKORI(R) (crizotinib)

PR60086

DARMSTADT, Germany and NEW YORK, Apr. 7 /PRN=KYODO JBN/ --

    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

    Merck of Darmstadt, Germany, is a leading company for innovative and

top-quality high-tech products in healthcare, life science and performance

materials. The company has six businesses - Biopharmaceuticals, Consumer

Health, Allergopharma, Biosimilars, Life Science and Performance Materials -

and generated sales of EUR 11.3 billion in 2014. Around 39,000 employees work

in 66 countries to improve the quality of life for patients, to foster the

success of customers and to help meet global challenges. Merck is the world's

oldest pharmaceutical and chemical company - since 1668, the company has stood

for innovation, business success and responsible entrepreneurship. Holding an

approximately 70% interest, the founding family remains the majority owner of

the company to this day. Merck holds the global rights to the Merck name and

brand. The only exceptions are Canada and the United States, where the company

operates as EMD Serono, EMD Millipore and EMD Performance Materials.

    All Merck press releases are distributed by e-mail at the same time they

become available on the Merck Website. Please go to

http://www.merckgroup.com/subscribe to register online, change your selection

or discontinue this service.

    Pfizer Disclosure Notice

    The information contained in this release is as of April 7, 2015. Pfizer

assumes no obligation to update forward-looking statements contained in this

release as the result of new information or future events or developments.

    This release contains forward-looking information about an agreement

between Pfizer and Merck to co-promote Pfizer's XALKORI in certain markets as

well as about the companies' immuno-oncology alliance involving avelumab and

Pfizer's anti-PD-1 antibody and clinical development plans, including their

potential benefits, that involves substantial risks and uncertainties that

could cause actual results to differ materially from those expressed or implied

by such statements. Risks and uncertainties include, among other things,

uncertainties regarding the success of the co-promotion arrangement and whether

the companies will realize the anticipated benefits of the co-promotion

arrangement; the uncertainties inherent in research and development, including

the ability to meet anticipated clinical study commencement and completion

dates as well as the possibility of unfavorable study results; risks associated

with interim data, including the risk that the final results of the Phase I

study for avelumab and/or additional clinical trials may be different from

(including less favorable than) the interim data results and may not support

further clinical development; the risk that clinical trial data are subject to

differing interpretations, and, even when we view data as sufficient to support

the safety and/or effectiveness of a product candidate, regulatory authorities

may not share our views and may require additional data or may deny approval

altogether; whether and when drug applications may be filed in any

jurisdictions for any potential product candidates or combination therapies;

whether and when any such applications may be approved by regulatory

authorities, which will depend on the assessment by such regulatory authorities

of the benefit-risk profile suggested by the totality of the efficacy and

safety information submitted; decisions by regulatory authorities regarding

labeling and other matters that could affect the availability or commercial

potential of any of such product candidates or combination therapies; and

competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's

Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and in

its subsequent reports on Form 10-Q, including in the sections thereof

captioned "Risk Factors" and "Forward-Looking Information That May Affect

Future Results", as well as in its subsequent reports on Form 8-K, all of which

are filed with the SEC and available at http://www.sec.gov and

http://www.pfizer.com.

    References

    1) American Cancer Society. (2011). Global Facts & Figures Second Edition.

Retrieved from:       

http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-027766.pdf

    2) American Cancer Society. (2014). Lung Cancer (Non-Small Cell) [Fact

sheet]. Retrieved from:       

http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf

    3) Blumenschein, G. R., Paulus, R., Curran, W. J., Robert, F., Fossella,

F., Werner-Wasik, M., Herbst, R. S., Doescher, P. O., Choy, H., & Komaki, R.

(2011). Phase II study of cetuximab in combination with chemoradiation in

patients with stage IIIA/B non-small-cell lung cancer: RTOG 0324. Journal of

clinical oncology: official journal of the American Society of Clinical

Oncology, 17, 2312-2318.

    4) Wood, S. L., Pernemalm, M., Crosbie, P. A., & Whetton, A. D. (2013). The

role of the tumor-microenvironment in lung cancer-metastasis and its

relationship to potential therapeutic targets. Cancer treatment reviews,

4,558-566.

SOURCE: Merck and Pfizer