Merck Provides Update on EU Marketing Authorization Application for Ridaforolimus


November 29, 2012 8:00 am ET

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

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 tumor.

Although the application for these uses was withdrawn, Merck is studying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 ridaforolimus.

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 malignancy.

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 therapies.

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
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This news release includes “forward-looking statements” within the
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The following factors, among others, could cause actual results to
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protections for innovative products; and the exposure to litigation
and/or regulatory actions.

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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
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Pam Eisele, +1 908-423-5042
Catherine Cantone, +1 908-423-5399
Carol Ferguson, +1 908-423-4465

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