Merck Announces FDA Acceptance of New Drug Application for Investigational Fertility Treatment


September 9, 2013 7:30 am ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the New Drug Application (NDA) for its
investigational fertility treatment, corifollitropin alfa, has been
accepted for standard review by the U.S. Food and Drug Administration
(FDA). Merck is seeking FDA approval of corifollitropin alfa for
Controlled Ovarian Stimulation (COS) in women participating in assisted
reproductive technology.

If approved, corifollitropin alfa would be the first sustained
follicular stimulant for use in a fertility treatment regimen.

“Infertility is an issue faced by many couples in the United States,”
said Barbara Stegmann, M.D., reproductive endocrinology and infertility
specialist, and principal scientist and clinical lead fertility, Merck.
“The filing of corifollitropin alfa is an example of Merck’s commitment
to patients and scientific innovation. We thank the patients and
physicians who have participated in the clinical trials that are so
essential to developing innovative fertility treatment options.”

Merck’s corifollitropin alfa is currently approved in more than 50
markets outside the United States, including the European Union.

About Merck

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well. Merck is known as MSD outside the United States and Canada.
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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 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
Tina Grasso, 267-893-9783
Carol Ferguson, 908-423-4465

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