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


March 27, 2013 8:00 am ET

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
) 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

About Merck

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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
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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 (

Pam Eisele, (908) 423-5042
Tracy Ogden, (267) 305-2301
Justin Holko, (908) 423-5088

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