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

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

Business Wire

WHITEHOUSE STATION, N.J. -- May 08, 2013

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 tablet. 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

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 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 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


Pam Eisele, 908-423-5042
Robert Consalvo, 908-423-6595
Justin Holko, 908-423-5088
Press spacebar to pause and continue. Press esc to stop.