Merck Statement on FDA Advisory Committee for GRASTEK® (Timothy Grass Pollen
Allergen Extract), Merck’s Investigational Sublingual Allergy Immunotherapy
WHITEHOUSE STATION, N.J. -- December 12, 2013
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today
issued the following statement after the conclusion of the Allergenic Products
Advisory Committee of the U.S. Food and Drug Administration (FDA) meeting to
discuss GRASTEK^® (Timothy grass pollen allergen extract). GRASTEK is the
proposed trade name for the company’s investigational sublingual tablet for
the treatment of Timothy grass induced allergic rhinitis, with or without
conjunctivitis, in appropriate adult and pediatric patients who are candidates
“We are pleased with the positive discussion of GRASTEK at today's advisory
committee meeting,” said Dr. Sean Curtis, vice president, Respiratory and
Immunology, Merck Research Laboratories. “We believe GRASTEK has the potential
to be an important new oral therapeutic option for allergy specialists and
their patients who continue to suffer with Timothy grass pollen induced
allergic rhinitis, and we look forward to continuing to work with the FDA as
the agency completes its review of our biologics license application for
The FDA is not bound by the Committee’s guidance, but takes its advice into
consideration when reviewing investigational medicines. Merck anticipates the
FDA’s review of GRASTEK to be completed in the first half of 2014.
GRASTEK is designed to help treat the underlying cause of allergic rhinitis by
generating an immune response to help protect patients against Timothy grass
Merck has partnered with ALK-Abello to develop its investigational sublingual
allergy immunotherapy tablets for Timothy grass pollen, ragweed pollen and
house dust mite induced allergic rhinitis in North America.
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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
Pamela Eisele, 908-423-5042
Robert Consalvo, 908-423-6595
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088
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