Merck Statement on FDA Advisory Committee for GRASTEK® (Timothy Grass Pollen Allergen Extract), Merck’s Investigational Sublingual Allergy Immunotherapy Tablet
December 12, 2013 7:17 pm ET
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 for
immunotherapy.
“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 GRASTEK.”
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 pollen.
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.
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).
Merck
Media:
Pamela Eisele, 908-423-5042
or
Robert Consalvo, 908-423-6595
or
Investors:
Carol Ferguson, 908-423-4465
or
Justin Holko, 908-423-5088
