Merck and PAREXEL Form Strategic Alliance Focused on Clinical Development of Biosimilar Candidates


January 12, 2011 7:30 am ET

PAREXEL to provide a broad range of regulatory and clinical services to Merck BioVentures including exclusivity for certain candidates

Merck (NYSE:MRK) (known outside the United States and Canada as MSD) and
PAREXEL International Corporation (NASDAQ: PRXL), a leading global
biopharmaceutical services provider, today announced that they have
entered into an alliance by which PAREXEL will provide strategic access
to global clinical development services for designated biosimilar
candidates to Merck BioVentures. Merck BioVentures, a division of Merck,
is focused on the delivery of high quality biosimilars to the patients
that need them.

“PAREXEL has extensive, industry-leading experience with biosimilar
development, and we truly understand the scientific complexities, and
regulatory pathways involved,” said Josef von Rickenbach, chairman and
chief executive officer of PAREXEL. “We are committed to working
with Merck BioVentures to assist in advancing its biosimilar portfolio
in this rapidly developing market segment for the benefit of patients

Under the terms of the agreement, PAREXEL will provide Merck BioVentures
with strategic access to a broad range of regulatory strategy and
clinical development planning capabilities for the development of
certain broad classes of biosimilars across various therapeutic areas,
including exclusivity for certain candidates. The agreement also
provides for the establishment of a dedicated Merck BioVentures unit
within the PAREXEL organization. Further details of the agreement were
not disclosed.

“Through this agreement, Merck BioVentures has secured broad strategic
access to PAREXEL’s proven biosimilar clinical development experience,”
said Michael Kamarck, president of Merck BioVentures. “This agreement
positions Merck BioVentures for success with an industry leading partner
that has the expertise and resources to conduct clinical development of
our diverse portfolio of candidates to allow timely delivery of products
to the marketplace.”

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
more information, visit

About PAREXEL International

PAREXEL International Corporation is a leading global bio/pharmaceutical
services organization, providing a broad range of knowledge-based
contract research, consulting, and medical communications services to
the worldwide pharmaceutical, biotechnology and medical device
industries. Committed to providing solutions that expedite
time-to-market and peak-market penetration, PAREXEL has developed
significant expertise across the development and commercialization
continuum, from drug development and regulatory consulting to clinical
pharmacology, clinical trials management, medical education and
reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL,
provides advanced technology solutions, including medical imaging, to
facilitate the clinical development process. Headquartered near Boston,
Massachusetts, PAREXEL operates in 71 locations throughout 54 countries
around the world, and has approximately 10,170 employees. For more
information about PAREXEL International visit

This release contains “forward-looking” statements regarding future
results and events, including, without limitation, statements regarding
expected financial results, future growth and customer demand. For this
purpose, any statements contained herein that are not statements of
historical fact may be deemed forward-looking statements. Without
limiting the foregoing, the words “believes,” “anticipates,” “plans,”
“expects,” “intends,” “appears,” “estimates,” “projects,” “will,”
“would,” “could,” “targets,” and similar expressions are also intended
to identify forward-looking statements. The forward-looking statements
in this release involve a number of risks and uncertainties. The
Company’s actual future results may differ significantly from the
results discussed in the forward-looking statements contained in this
release. Important factors that might cause such a difference include,
but are not limited to, risks associated with: actual operating
performance; actual expense savings and other operating improvements
resulting from recent and anticipated restructurings, the loss,
modification, or delay of contracts which would, among other things,
adversely impact the Company’s recognition of revenue included in
backlog; the Company’s dependence on certain industries and clients; the
Company’s ability to win new business, manage growth and costs, and
attract and retain employees; the Company’s ability to complete
additional acquisitions and to integrate newly acquired businesses or
enter into new lines of business; the impact on the Company’s business
of government regulation of the drug, medical device and biotechnology
industry; consolidation within the pharmaceutical industry and
competition within the biopharmaceutical services industry; the
potential for significant liability to clients and third parties; the
potential adverse impact of health care reform; and the effects of
exchange rate fluctuations and other international economic, political,
and other risks. Such factors and others are discussed more fully in the
section entitled “Risk Factors” of the Company’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2010 as filed with the SEC
on November 9, 2010, which “Risk Factors” discussion is incorporated by
reference in this press release. The Company specifically disclaims any
obligation to update these forward-looking statements in the future.
These forward-looking statements should not be relied upon as
representing the Company’s estimates or views as of any date subsequent
to the date of this press release.

PAREXEL is a registered trademark of PAREXEL International Corporation,
and Perceptive Informatics is a trademark of Perceptive Informatics,
Inc. All other names or marks may be registered trademarks or trademarks
of PAREXEL International Corporation, Perceptive Informatics, Inc. or
their respective owners and are hereby acknowledged.

Merck Forward Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. The forward-looking statements
may include statements regarding product development, product potential,
the company’s plans, objectives, expectations and intentions and other
statements that are not historical facts. Such statements are based upon
the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. Actual results may
differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
impact of pharmaceutical industry regulation and health care
legislation; Merck’s ability to accurately predict future market
conditions; dependence on the effectiveness of Merck’s patents and other
protections for innovative products; the risk of new and changing
regulation and health policies in the United States and internationally
and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2009 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (

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