Healthcare Industry News: patient assistance program
News Release - March 14, 2017
Pfizer Launches Zavicefta(TM) (ceftazidime-avibactam) in the U.K. and Germany, a New Antibiotic to Treat Complicated Infections Caused by Gram-Negative BacteriaNEW YORK--(Healthcare Sales & Marketing Network)--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.
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.
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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