Merck Announces CHMP Issues Positive Opinion for Investigational Antibiotic SIVEXTRO® (tedizolid phosphate)
January 26 2015 - 8:30AM
Business Wire
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
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside of the United States
and Canada. Through our prescription medicines, vaccines, biologic
therapies 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.
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, 267-305-3558Jennifer Baird,
781-860-1282orInvestor:Joseph Romanelli, 908-740-1986Justin Holko,
908-740-1879
Merck (NYSE:MRK)
Historical Stock Chart
From Aug 2024 to Sep 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Sep 2023 to Sep 2024