Merck Receives Complete Response Letter from U.S. Food and Drug Administration for Investigational Medicine Ridaforolimus
June 5, 2012 3:35 pm ET
Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA) has
issued a complete response letter regarding the New Drug Application
(NDA) for ridaforolimus. Ridaforolimus is an investigational oral mTOR
inhibitor under development for maintenance therapy for patients with
metastatic soft tissue or bone sarcoma who have stable disease or better
after four or more cycles of chemotherapy.
The complete response letter states that FDA cannot approve the
application in its present form, and that additional clinical trial(s)
would need to be conducted to further assess safety and efficacy. Merck
also is in ongoing discussions with health authorities in
Europe and other countries as part of their application procedures for
ridaforolimus for the treatment of metastatic soft-tissue or bone
sarcomas in patients who had a favorable response to chemotherapy.
Additionally, Merck is studying ridaforolimus in combination with other
mechanisms in several tumor types.
“Merck remains confident in the potential of ridaforolimus,” said Eric
Rubin, M.D., vice president, Clinical Research Oncology, Merck. “We will
continue to work closely with the FDA to define potential paths forward
for this investigational therapy.”
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 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.
As part of an exclusive license agreement with ARIAD Pharmaceuticals,
Inc (Nasdaq: ARIA), Merck is responsible for the development and
worldwide commercialization of ridaforolimus in oncology.
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.
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 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 (www.sec.gov).
Pam Eisele, 908-423-5042
Catherine Cantone, 908-423-5399
Carol Ferguson, 908-423-4465