http://www.merck.com/newsroom/news-release-archive/research-and-development/2011_1005.html
FDA Accepts New Drug Application Filing for
Ridaforolimus, Investigational mTOR Inhibitor
WHITEHOUSE STATION, N.J. & CAMBRIDGE, Mass., Oct. 5, 2011 — 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.
About Sarcoma
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.
About Ridaforolimus
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.
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
www.merck.com and connect
with us on Twitter, Facebook and YouTube.
About ARIAD
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
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 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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