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


May 8, 2013 7:30 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 ragweed pollen (Ambrosia artemisiifolia)
sublingual allergy immunotherapy tablet has been accepted for review by
the U.S. Food and Drug Administration (FDA). On March 27, Merck
announced that the FDA had also accepted the BLA for its investigational Timothy
grass pollen (Phleum pratense) sublingual allergy immunotherapy
. Merck expects the FDA’s review for both to be completed in
the first half of 2014.

The BLA for Merck’s investigational ragweed pollen sublingual allergy
immunotherapy tablet is supported by five studies evaluating the
efficacy and safety of the tablet in adults, 18 years of age or older,
with ragweed induced allergic rhinitis (with or without conjunctivitis).

“Merck has a long history of developing new therapies to help patients
with allergic rhinitis,” said Jeffrey A. Chodakewitz, M.D., senior vice
president, interim franchise head, Respiratory & Immunology, Merck
Research Laboratories. “This regulatory milestone for our
investigational ragweed pollen sublingual allergy immunotherapy tablet
represents another step in our continued commitment to offering
potential new options to allergy specialists and their patients.”

Merck’s ragweed pollen sublingual allergy immunotherapy tablet 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 the targeted allergen. Merck has partnered with
ALK-Abello to develop its sublingual allergy immunotherapy tablets for
ragweed pollen, timothy grass pollen and house dust mite 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
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 (

Pam Eisele, 908-423-5042
Robert Consalvo, 908-423-6595
Justin Holko, 908-423-5088

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