FDA Accepts New Drug Application Filing for Ridaforolimus, Investigational mTOR Inhibitor
October 5, 2011 6:35 am ET
Merck (NYSE:MRK), known outside the United States and Canada as MSD, and
ARIAD Pharmaceuticals, Inc., (NASDAQ:ARIA), today announced that the
U.S. Food and Drug Administration (FDA) has accepted for filing and
review the New Drug Application (NDA) for ridaforolimus, an
investigational oral mTOR inhibitor under development for the treatment
of metastatic soft-tissue or bone sarcomas in patients who had a
favorable response to chemotherapy. The FDA assigned a Standard review
classification to this application.
Merck and ARIAD previously announced that the European Medicines Agency
had accepted the marketing authorization application for ridaforolimus.
As part of an exclusive license agreement with ARIAD, Merck is
responsible for the development and worldwide commercialization of
ridaforolimus in oncology. ARIAD intends to co-promote ridaforolimus in
the United States.
Sarcomas are a group of cancers of connective tissue of the body for
which there are currently limited treatment options. Sarcomas can arise
anywhere in the body and are divided into two main groups – bone tumors
and soft-tissue sarcomas.
Ridaforolimus is an investigational targeted and potent 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.
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 www.merck.com
and connect with us on Twitter, Facebook and YouTube.
ARIAD Pharmaceuticals, Inc. is an emerging global oncology company
focused on the discovery, development and commercialization of medicines
to transform the lives of cancer patients. ARIAD’s approach to
structure-based drug design has led to three internally discovered,
molecularly targeted product candidates for drug-resistant and
difficult-to-treat cancers, including certain forms of chronic myeloid
leukemia, soft tissue and bone sarcomas and non-small cell lung cancer.
For additional information, visit http://www.ariad.com.
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
The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that 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; the risk that the businesses will not be
integrated successfully; disruption from the merger making it more
difficult to maintain business and operational relationships; Merck’s
ability to accurately predict future market conditions; dependence on
the effectiveness of Merck’s patents and other protections for
innovative products; the risk of new and changing regulation and health
policies in the United States and internationally 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 2010 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).
ARIAD Forward-Looking Statement
This press release contains “forward-looking statements” including, but
not limited to, statements relating to clinical data for ridaforolimus
in the treatment of metastatic soft-tissue and bone sarcomas.
Forward-looking statements are based on management’s expectations and
are subject to certain factors, risks and uncertainties that may cause
actual results, outcome of events, timing and performance to differ
materially from those expressed or implied by such statements. These
risks and uncertainties include, but are not limited to, results of
clinical studies of the Company’s product candidates, timing and
acceptance of regulatory filings for drug approval, and other factors
detailed in the Company’s public filings with the U.S. Securities and
Exchange Commission. The information contained in this press release is
believed to be current as of the date of original issue. The Company
does not intend to update any of the forward-looking statements after
the date of this document to conform these statements to actual results
or to changes in the Company’s expectations, except as required by law.
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Ian McConnell, 908-423-3046
Noreen Verbrugge, 908-423-6301
Carol Ferguson, 908-423-4465
Liza Heapes, 617-621- 2315
Maria E. Cantor, 617-621-2208