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

Geschrieben am 07-04-2015

Darmstadt, Germany And New York (ots/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_Informa
tion/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.


ots Originaltext: Merck and Pfizer
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Your Contacts: Merck: Media: Markus Talanow +49-6151-72-7144 /
Investor Relations: +49-6151-72-3321. Pfizer: Media: Sally Beatty
+1-212-733-6566 / Investor Relations: Ryan Crowe +1-212-733-8160


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