Merck Announces Canadian Approval of GRASTEK® (Standardized Allergenic Extract, Timothy Grass (Phleum pratense) Sublingual Tablet)
February 3, 2014 8:30 am ET
GRASTEK (Timothy Grass Pollen Allergen Extract) Remains Under FDA Review in the United States
Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced the regulatory approval and launch of GRASTEK®
(Timothy grass pollen allergen extract) sublingual tablets in Canada.
This represents the first approval of GRASTEK for Merck. The product is
currently marketed by ALK-Abello in Europe as GRAZAX.
Merck previously announced that the U.S. Food and Drug Administration
(FDA) had accepted for review Biologics License Applications for GRASTEK
and for its investigational ragweed sublingual allergy immunotherapy
tablet. Merck expects the FDA’s review for both to be completed in the
first half of 2014.
Merck has partnered with ALK-Abello to develop its sublingual allergy
immunotherapy tablets for Timothy grass pollen, ragweed pollen and house
dust mite-induced allergic rhinitis in North America.
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well. Merck is known as MSD outside the United States and Canada.
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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 (www.sec.gov).
GRASTEK® is a registered trademark of Merck
& Co., Inc., Whitehouse Station, N.J., USA.
Pamela Eisele, 267-305-3558
Robert Consalvo, 908-423-6595
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088