Merck Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen Allergy Immunotherapy Tablet

  Merck Announces FDA Acceptance of Biologics License Application for
  Investigational Grass Pollen Allergy Immunotherapy Tablet

Business Wire

WHITEHOUSE STATION, N.J. -- March 27, 2013

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today
announced that the Biologics License Application (BLA) for its investigational
Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has
been accepted for review by the U.S. Food and Drug Administration (FDA). In
March, the company also submitted a BLA to the FDA for its investigational
ragweed pollen (Ambrosia artemisiifolia) AIT.

The BLA for Merck’s grass pollen AIT is supported by Phase III trials that
evaluated the safety and efficacy of the investigational product, including a
long-term, multi-season trial.

“We are pleased to have achieved this important milestone in the development
of our investigational grass pollen AIT, which, if approved, would represent a
potential new option for allergy specialists to offer appropriate allergic
rhinitis patients,” said Jeffrey A. Chodakewitz, M.D., senior vice president,
Global Scientific Strategy, franchise head, Infectious Diseases and interim
franchise head, Respiratory & Immunology, Merck Research Laboratories.

Merck's grass pollen (Phleum pratense) AIT is an investigational sublingual
dissolvable tablet designed to help treat the underlying cause of allergic
rhinitis by generating an immune response to help protect against targeted
allergens. Merck has partnered with ALK-Abello to develop its grass pollen
(Phleum pratense) AIT in North America.

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 www.merck.com and
connect with us on Twitter, Facebook and YouTube.

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. These statements are based upon the current beliefs and
expectations of Merck’s management and are subject to significant risks and
uncertainties. There can be no guarantees with respect to pipeline products
that the products will receive the necessary regulatory approvals or that they
will prove to be commercially successful. If underlying assumptions prove
inaccurate or risks or uncertainties materialize, actual results may differ
materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest rate
and currency exchange rate fluctuations; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; global trends toward health care cost containment;
technological advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining regulatory
approval; Merck’s ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of international
economies and sovereign risk; dependence on the effectiveness of Merck’s
patents and other protections for innovative products; and the exposure to
litigation, including patent 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 2012
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
(www.sec.gov).

Contact:

Merck
Media:
Pam Eisele, (908) 423-5042
Tracy Ogden, (267) 305-2301
or
Investors:
Justin Holko, (908) 423-5088
 
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