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

Wed Mar 27, 2013 8:00am EDT

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WHITEHOUSE STATION, N.J.--(Business Wire)--
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today
announced that the Biologics License Application (BLA) for its investigational
Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has
been accepted for review by the U.S. Food and Drug Administration (FDA). In
March, the company also submitted a BLA to the FDA for its investigational
ragweed pollen (Ambrosia artemisiifolia) AIT. 

The BLA for Merck`s grass pollen AIT is supported by Phase III trials that
evaluated the safety and efficacy of the investigational product, including a
long-term, multi-season trial. 

"We are pleased to have achieved this important milestone in the development of
our investigational grass pollen AIT, which, if approved, would represent a
potential new option for allergy specialists to offer appropriate allergic
rhinitis patients," said Jeffrey A. Chodakewitz, M.D., senior vice president,
Global Scientific Strategy, franchise head, Infectious Diseases and interim
franchise head, Respiratory & Immunology, Merck Research Laboratories. 

Merck's grass pollen (Phleum pratense) AIT 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 targeted
allergens. Merck has partnered with ALK-Abello to develop its grass pollen
(Phleum pratense) AIT 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,
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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
Tracy Ogden, (267) 305-2301
Justin Holko, (908) 423-5088 

Copyright Business Wire 2013