Zavicefta™ Launches Address Urgent Medical Need for New Antibiotics
NEW YORK--(BUSINESS WIRE)--
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
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In addition, to learn more, please visit us on www.pfizer.com
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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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Source: Pfizer Inc.