Merck Announces CHMP Issues Positive Opinion for Investigational Antibiotic SIVEXTRO® (tedizolid phosphate)
January 26, 2015 8:30 am ET
Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has adopted a positive
opinion recommending approval of the investigational antibiotic SIVEXTRO®
(tedizolid phosphate) for the treatment of acute bacterial skin and skin
structure infections (ABSSSI) in adults. Merck acquired SIVEXTRO as a
part of its purchase, through a subsidiary, of Cubist Pharmaceuticals,
Inc.
The CHMP positive opinion will be reviewed by the European Commission.
If the European Commission affirms the CHMP opinion, it will grant a
centralized marketing authorization with unified labeling that is valid
in the 28 countries that are members of the European Union, as well as
European Economic Area members, Iceland, Liechtenstein and Norway.
SIVEXTRO is a once-daily oxazolidinone antibiotic developed for both
intravenous and oral administration for the treatment of serious
infections caused by certain Gram-positive bacteria.
SIVEXTRO in the U.S.
SIVEXTRO is approved in the U.S. and is indicated for the treatment of
acute bacterial skin and skin structure infections (ABSSSI) caused by
susceptible isolates of the following Gram-positive microorganisms: Staphylococcus
aureus (including methicillin-resistant [MRSA] and
methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus
agalactiae, Streptococcus anginosus group (including Streptococcus
anginosus, Streptococcus intermedius and Streptococcus
constellatus), and Enterococccus faecalis.
Selected Safety Information
Patients with neutropenia: The safety and efficacy of SIVEXTRO
(tedizolid phosphate) in patients with neutropenia (neutrophil counts
<1000 cells/mm3) have not been adequately evaluated. In an animal model
of infection, the antibacterial activity of SIVEXTRO was reduced in the
absence of granulocytes. Alternative therapies should be considered when
treating patients with neutropenia and acute bacterial skin and skin
structure infection.
Clostridium difficile-associated diarrhea (CDAD),
ranging from mild diarrhea to fatal colitis, has been reported with
nearly all systemic antibacterial agents, including SIVEXTRO. Evaluate
all patients who present with diarrhea following SIVEXTRO use.
Development of drug-resistant bacteria: Prescribing SIVEXTRO in
the absence of a proven or strongly suspected bacterial infection or
prophylactic indication is unlikely to provide benefit to the patient
and increases the risk of the development of drug resistant bacteria.
The most common adverse reactions for SIVEXTRO are nausea, headache,
diarrhea, vomiting, and dizziness.
About Merck
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well. Merck is known as MSD outside of the United States and Canada.
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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. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. There can be no
guarantees with respect to pipeline products that the products will
receive the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck patents and other protections
for innovative products; and the exposure to litigation, including
patent 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 2013 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).
Please see Prescribing Information for SIVEXTRO (tedizolid phosphate)
at http://sivextro.com/pdf/sivextro-prescribing-info.pdf.
SIVEXTRO® is a registered trademark of
Cubist Pharmaceuticals, Inc., a wholly-owned subsidiary of Merck & Co.,
Inc., Kenilworth, N.J., USA.
Media:
Pam Eisele, 267-305-3558
Jennifer Baird, 781-860-1282
or
Investor:
Joseph Romanelli, 908-740-1986
Justin Holko, 908-740-1879
