Zavicefta™ Launches Address Urgent Medical
Need for New Antibiotics
Pfizer Inc. today announced that Zavicefta, a novel combination
antibiotic for the treatment of patients with certain confirmed or
suspected Gram-negative bacterial infections requiring
hospitalization, is now available in the U.K. and Germany. Pfizer
expects to launch Zavicefta in additional markets outside the U.S.
throughout 2017 and 2018. Zavicefta was developed in response to
the urgent medical need for new antibiotics for difficult-to-treat
Gram-negative bacteria, many of which have become increasingly
resistant to currently available antibiotics.
In June 2016, the European Medicines Agency (EMA) approved the
marketing authorization for Zavicefta based on an extensive
clinical trial program. Zavicefta is indicated for the treatment of
adults with complicated intra-abdominal infection (cIAI),
complicated urinary tract infection (cUTI) and Hospital-Acquired
Pneumonia (HAP), including Ventilator Associated Pneumonia (VAP).
Zavicefta is also indicated for the treatment of infections due to
aerobic Gram-negative organisms in adult patients with limited
treatment options. Zavicefta addresses Pseudomonas Aeruginosa and
Enterobacteriaceae, two of three “critical” pathogens recently
identified by the World Health Organization (WHO)1. In many
markets, existing treatments do not consistently address these
resistant pathogens adequately.
“Multidrug-resistant (MDR) infections are an increasing
global threat. The availability of Zavicefta is a major step
forward for physicians faced with the challenge of treating
patients with known or suspected MDR infections,” said Dr.
Matteo Bassetti, Chief of the Infectious Diseases Clinic at
University of Udine in Italy.
“The launch of Zavicefta reaffirms Pfizer’s longstanding
heritage and commitment to patients facing serious infectious
diseases,” said Dr. Freda Lewis-Hall, Executive Vice President and
Chief Medical Officer of Pfizer Inc. “We continue to search for
solutions to one of humanity’s most pressing challenges—defeating
the microbes that cause infection and misery.”
About Antimicrobial
Resistance
The WHO characterizes antimicrobial resistance as one of the
biggest threats to global health, that can affect anyone at any age
in any country, threatening our ability to treat serious infections
and provide standard medical procedures. Gram-negative bacteria,
the cause of many healthcare-associated infections (HAIs), have
become increasingly resistant to many available antibiotic
treatments. These infections are associated with increased patient
mortality and cost of care. At present, approximately 700,000
deaths per year are attributed to antimicrobial resistance
globally, with an increase to 10 million predicted by 2050 if no
action is taken to address this issue. For example, according to
the European Centre for Disease Prevention and Control (ECDC)
Gram-negative bacteria are responsible for approximately two-thirds
of the estimated 25,000 deaths that result from antimicrobial
resistance annually in Europe.
About Pfizer
Anti-Infectives
Since its pioneering work on penicillin in the 1940s, Pfizer has
been actively engaged in the research and development of innovative
medicines, policies and educational programs to address the
evolving needs of patients and physicians in the area of infectious
diseases.
For more than 30 years, Pfizer has been a leader in developing
and implementing innovative public-private partnerships designed to
address unmet medical needs and global public health issues. Today,
our patient assistance programs expand access to potentially
lifesaving medicines and provide educational resources that empower
patients and physicians in the fight against infectious disease.
Click here to learn more.
About Zavicefta
Zavicefta (ceftazidime-avibactam) is a fixed-dose combination
antibacterial that was developed to treat serious Gram-negative
bacterial infections. It consists of a combination of avibactam and
ceftazidime – a third-generation antipseudomonal cephalosporin with
a well-established efficacy and safety profile. Avibactam is a
first-in-class broad-spectrum β-lactamase inhibitor, which protects
ceftazidime against degradation by Class A, C and some D,
β-lactamases.Avibactam does not inhibit class B enzymes
(metallo-β-lactamases) and is not able to inhibit many of the class
D enzymes.
Pfizer holds the global rights to commercialize Zavicefta, with
the exception of North America (U.S. and Canada), where the rights
are held by Allergan.
Important Zavicefta Safety
Information
In clinical studies, ceftazidime-avibactam was proven to be as
effective as current carbapenem standards of care in the treatment
of serious aerobic Gram-negative infections, including in patients
with infections caused by ceftazidime-resistant bacteria. The most
common adverse events occurring in 5% or more of patients (n=2024
from seven Phase 2 and 3 clinical trials) treated with
ceftazidime-avibactam included: the presence of antibodies that
cause red blood cells to die early (positive Coombs direct test),
nausea and diarrhea. Nausea and diarrhea were usually mild or
moderate in intensity.
Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.pfizer.com. In
addition, to learn more, please visit us on www.pfizer.com and
follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this
release is as of March 14, 2017. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information regarding
Zavicefta (ceftazidime-avibactam), launch plans and Pfizer’s
anti-infectives portfolio, including their potential benefits, that
involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, uncertainties regarding the commercial success of
Zavicefta; the uncertainties inherent in research and development;
whether and when any drug applications may be filed in any
additional jurisdictions for Zavicefta; whether and when regulatory
authorities in any such other jurisdictions where applications may
be filed or pending may approve such applications, which will
depend on the assessment by such regulatory authorities of the
benefit-risk profile suggested by the totality of the efficacy and
safety information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of Zavicefta;and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results,” as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
NOTES TO EDITORS
About Pfizer’s Commitment to
AMR
Today, Pfizer is the leading global provider of anti-infective
medicines in the industry, offering patients access to a diverse
portfolio of more than 80 products. Pfizer recognizes the serious
public health threat associated with Antimicrobial Resistance (AMR)
and has taken significant steps to address this issue. In early
2016, Pfizer was a signatory of the Declaration on Combating
Antimicrobial Resistance (AMR), a global call-to-action drafted and
signed by more than 100 companies and 13 trade associations
encouraging greater industry and government collaboration to
address the issue of antimicrobial resistance. As a follow-up to
the AMR Declaration, Pfizer and 13 industry partners unveiled the
“Industry Roadmap to Combat Antimicrobial Resistance,” a
comprehensive plan of action, that lays out four key commitments we
pledge to deliver by 2020. For more information on Pfizer’s
commitment to AMR, please click here.
1 On February 27th, the World Health Organization (WHO)
published its first ever list of antibiotic resistant “priority
pathogens which pose the greatest threat to human health.”
Zavicefta addresses Pseudomonas Aeruginosa and Enterobacteriaceae,
two of the “critical” pathogens identified by the WHO.
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