Merck Provides Update on EU Marketing Authorization Application for Ridaforolimus

  Merck Provides Update on EU Marketing Authorization Application for

Business Wire

WHITEHOUSE STATION, N.J. -- November 29, 2012

Merck, known as MSD outside the U.S. and Canada, announced today that it has
formally notified the European Medicines Agency (EMA) of Merck's decision to
withdraw the Marketing Authorisation Application (MAA) for ridaforolimus.

The application for Marketing Authorisation for ridaforolimus was accepted by
the EMA in August 2011. At the time of the withdrawal it was under review by
the Agency’s Committee for Medicinal Products for Human Use (CHMP). In its
letter to the EMA, Merck said that the withdrawal of ridaforolimus was based
on the provisional view of the CHMP that the data available to date and
provided in the Marketing Authorisation Application were not sufficient to
permit licensure of ridaforolimus in the European Union for the maintenance
treatment of patients with soft tissue sarcoma or primary malignant bone

Although the application for these uses was withdrawn, Merck is studying
ridaforolimus in combination with other drugs in other tumor types. The
withdrawal of the European application of ridaforolimus for the maintenance
treatment of patients with soft tissue sarcoma or primary malignant bone tumor
does not change Merck’s commitment to the ongoing clinical trials with

About Ridaforolimus

Ridaforolimus is an investigational small-molecule inhibitor of the protein
mTOR, a protein that acts as a central regulator of protein synthesis, cell
proliferation, cell cycle progression and cell survival, integrating signals
from proteins, such as PI3K, AKT and PTEN, known to be important to

Merck’s Commitment to Oncology

Merck is committed to advancing all aspects of cancer care – prevention,
treatment and supportive care. Through strong internal research capabilities,
selective alliances and acquisitions, and enabling technologies, Merck is
looking to lead in the discovery, development and delivery of anticancer

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 and
connect with us on Twitter, Facebook and YouTube.

Merck 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. Such statements may include, but are not limited to,
statements about the benefits of the merger between Merck and Schering-Plough,
including future financial and operating results, the combined company’s
plans, objectives, expectations and intentions and other statements that are
not historical facts. Such statements are based upon the current beliefs and
expectations of Merck’s management and are subject to significant risks and
uncertainties. Actual results may differ from those set forth in the
forward-looking statements.

The following factors, among others, could cause actual results to differ from
those set forth in the forward-looking statements: the possibility that all of
the expected synergies from the merger of Merck and Schering-Plough will not
be realized, or will not be realized within the expected time period; the
impact of pharmaceutical industry regulation and health care legislation in
the United States and internationally; Merck’s ability to accurately predict
future market conditions; dependence on the effectiveness of Merck’s patents
and other protections for innovative products; and the exposure to 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 2011
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, +1 908-423-5042
Catherine Cantone, +1 908-423-5399
Carol Ferguson, +1 908-423-4465
Press spacebar to pause and continue. Press esc to stop.