|Applicable indicator||Not applicable|
Pfizer** is among the top performing large research-based pharmaceutical companies, following close behind the leaders. It performs well in Manufacturing & Production and Appropriate Access & Stewardship, achieving an average performance in Research & Development. The company does not report its antimicrobial R&D investments and its R&D pipeline is comparatively small compared to other large researchbased pharmaceutical companies assessed by the Benchmark: seven antimicrobial projects. Notably, six of these target priority pathogens, including four vaccines. It has access provisions in place for its vaccines in late-stage development. Pfizer discloses a comprehensive environmental risk-management strategy, which includes discharge limits and reportedly applies to all Pfizer’s third-party suppliers of antibiotic APIs and drug products. Pfizer has filed four of its five newest antibiotics in countries in scope.* It also reports having mechanisms in place for responding efficiently to stock-outs in countries in scope.* Regarding stewardship, Pfizer is engaged in a number of AMR educational and training activities for healthcare professionals, taking steps to mitigate conflicts of interest, as well as engaging in established AMR surveillance programmes that have an emphasis on data-sharing.
Sales & operations
Pfizer is a large research-based pharmaceutical company with two business segments: Pfizer Essential Health and Pfizer Innovative Health, which includes vaccines. Pfizer sells antimicrobial medicines in at least 122 countries globally, of which 53 or more are low- to middle-income countries.* In 2016, the company sold more than 160 million doses of vaccines, including 61 million doses of Prevnar 13® in partnership with Gavi, the Vaccines Alliance. In 2009, GSK and Pfizer established ViiV Healthcare (GSK: 76.5%, Pfizer: 13.5% and Shionogi: 10%), a joint venture solely focused on the development of HIV/ AIDS medicines. In 2015, Pfizer completed the acquisition of Hospira — a provider of generic injectable medicines (including antimicrobials) and biosimilars. In 2016, the company acquired AstraZeneca’s small-molecule anti-infectives business and late-stage pipeline, including commercialisation rights to avibactam/ceftazidime (Zavicefta™).** In 2017, Pfizer and Basilea Pharmaceutica Ltd. entered into an agreement whereby Pfizer was granted exclusive rights to develop and commercialise the antifungal isavuconazole (Cresemba®) in several European countries, China and 16 Asian-Pacific countries (exc. Japan).** Pfizer purchased two meningococcal vaccines, Mencevax® and Nimenrix®, from GSK in 2015. It had previously purchased from Baxter, in 2014, the vaccines NeisVac-C® and FSME-IMMUN®/TicoVac®, indicated for meningitis and tick-borne encephalitis, respectively.
Pfizer markets at least 114 antimicrobial medicines, the largest reported antimicrobial portfolio among the large research-based pharmaceutical companies assessed by the Benchmark. Sixty of these 114 medicines are listed on the WHO EML (Section 6). Eighty-three of the company’s antimicrobial medicines are antibiotics, with 45 listed on the WHO EML (Section 6), including seven in the EML’s Reserve group. The remainder (31) of the company’s portfolio includes antifungals (systemic and topical), antiprotozoals and anthelminthics, as well as eight antivirals. Pfizer also markets two antiseptic irrigation solutions and six vaccines, including Prevnar 13® for pneumococcal pneumonia, and four meningococcal vaccines.
Plan ahead for access and stewardship during R&D. Pfizer has registration and affordability plans in place for all of its vaccine candidates. It also has stewardship plans in place for its antibiotic candidate (avibactam/aztreonam) in the form of AMR surveillance programmes and educational activities for HCPs. Pfizer can ensure that access plans are also in place for avibactam/aztreonam.
Improve transparency regarding environmental risk. Pfizer can share more information on how it manages environmental risk, e.g., the company can disclose the levels of antibiotic discharge, and publish the identities of third parties who manufacture antibiotic APIs and drug products on its behalf. Currently, Pfizer discloses several policy documents on its environmental risk management.
Expand environmental risk-management strategy. Pfizer has set discharge limits for its own manufacturing sites and third parties who manufacture antibiotic APIs and drug products as part of its environmental risk-management strategy. It can ensure these antibiotic discharge limits are applied to external waste-treatment sites.
Ensure access to more antimicrobials. Pfizer is currently committed to engaging in inter-country equitable pricing for its antimicrobial medicines. Pfizer can expand its affordability strategy by engaging in intra-country equitable pricing for its antimicrobial medicines, and improving access to recently acquired assets from AstraZeneca and Basilea such as avibactam/ceftazidime (Zavicefta®) and isavuconazole (Cresemba®).
A. Research & Development
7 projects, 6 target priority pathogen
A.1 No information on antimicrobial R&D investments.
Pfizer reports no information on its antimicrobial R&D investments.
A.2.1-2.3 Six R&D projects focussed on priority pathogens.
Pfizer has seven antimicrobial R&D projects in its pipeline, six of which are in clinical stage development. Six of the company’s projects target priority pathogens. Although Pfizer has a smaller pipeline compared to leaders in this area, all of its projects focus on multidrug-resistant bacterial infections. Pfizer has one project in preclinical development that focusses on new fixed dose combinations (FDCs) of existing β-lactam and β-lactamase inhibitors. Pfizer is involved in the clinical development of new vaccines and new FDCs of existing antibiotics. This includes the development of a new combination of the existing β-lactam aztreonam and theβ-lactamase inhibitor avibactam, a project that was obtained with the acquisition of AstraZeneca’s antibiotics division, in collaboration with Allergan. Pfizer has no new chemical entities in its pipeline. Nevertheless, it has four vaccines in clinical development targeting S. aureus, C. difficile and group B Streptococcus (for which no vaccines currently exist) and a 20-valent pneumococcal vaccine.
A.3 Two R&D projects being developed with public partners.
Pfizer is developing two R&D projects in its priority pathogen pipeline through public-private partnerships (including non-profit organisations).*** After acquiring avibactam from AstraZeneca in 2016, Pfizer continued the development of avibactam/aztreonam in collaboration with Allergan, currently in Phase II clinical development, through the COMBACTE-CARE programme (IMI’s New Drugs 4 Bad Bugs consortium). The project also includes funding from BARDA. In 2016, Pfizer received funding from the Bill and Melinda Gates Foundation to conduct a Phase I/II clinical trial to evaluate the investigational group B Streptococcus (GBS) vaccine in South Africa. Moreover, Pfizer is part of a public-private consultation group led by WHO on group B Streptococcus vaccine development, which aims to develop standardised antibody assays to identify correlates of protection.
A.4 Access provisions in place for its vaccines in late-stage development.
Pfizer reports that it has access provisions in place for both of its vaccines in late-stage development. It reports that it has a stewardship provision in place for its antibiotic candidate in latestage development, and commits to plan access plans during R&D but does not provide information on details of such action plans. For its two vaccines in Phase II and III clinical stage, it will apply an equitable pricing policy that is based on countries’ ability to pay, while covering research and development costs. It is unknown if this policy applies to its avibactam/aztreonam combination. Furthermore, Pfizer plans to continue its AMR surveillance programmes, as well as launch educational initiatives regarding the risks of AMR and how vaccines could play a role in addressing this public health threat. For this indicator, countries in scope are 106 low- and middle- income countries where access to medicine is likely limited.
Pipeline targeting priority pathogens
B. Manufacturing & Production
B.1 Comprehensive environmental risk-management strategy.
Pfizer undertakes many of the environmental risk-management activities that the Benchmark examines. Namely, it applies an environmental risk-management strategy to minimise the impact of antibiotic manufacturing discharge. It includes auditing and limits on antibiotic discharge, at its own manufacturing sites and those of third-party manufacturers of antibiotic APIs and drug products. Pfizer’s manufacturing sites include primary waste treatment. Secondary waste treatment occurs on- and off-site. The environmental risk-management strategy does not apply to off-site waste-treatment plants.
B.2 Limited transparency regarding environmental risk management.
Pfizer publishes elements of its environmental risk-management strategy on its website. It does not disclose audit results, or the discharge levels of antibiotics. The company also does not share the identities of its third-party suppliers of antibiotic APIs and drug products or external waste-treatment plants.
B.3 Commits to following GMP, including at 3rd-party sites.
Pfizer reports that it has mechanisms for maintaining a high quality of antibiotic production — namely following GMP standards. This commitment applies to its own manufacturing sites. Pfizer requires its third-party suppliers of drug products to apply the same quality standards to their production facilities.
C. Appropriate Access & Stewardship
C.1 Filed four of five newest antibiotics in countries in scope.
Pfizer reports that it has filed four of its five newest antibiotics, introduced in 1991-2005, for registration in countries in scope* (between 30-63 countries). The fifth antibiotic, introduced in 1999, has not been filed for registration in any country in scope.* Pfizer did not report filing information about newer antibiotics acquired recently (i.e., from AstraZeneca in 2016 and from Basilea in 2017), as these products are still being integrated into the Pfizer portfolio (e.g., ongoing MAA transfer processes in several markets).
C.2 Makes general commitment to equitable pricing.
Pfizer discloses a general (not product-specific) commitment to applying inter- and intra-country equitable pricing to antimicrobials in countries in scope.* Pfizer is also committed to long-term public-private donation programmes for azithromycin (Zithromax®) and fluconazole (Diflucan®).
C.3 Mechanisms in place to respond to stock-outs.
Pfizer reports that it has mechanisms in place for responding efficiently to stock-outs of all of its antimicrobial medicines and vaccines in countries in scope.* These are based on a set of demand and supply principles, such as ensuring supplies are distributed equitably between countries, sharing information on shortages with purchasers, and assigning additional resources in the event of delays. Pfizer does not disclose how it works with stakeholders (e.g., governments, procurers) to align supply and demand for antimicrobial medicines, specifically to prevent or minimise stock-outs in countries in scope.* It has launched a website on supply status of injectables, including antimicrobial medicines such as piperacillin/tazobactam (Zosyn®).
C.4 Multiple activities in AMR-related educational programmes.
Pfizer reports that it is involved in educational programmes for HCPs that include AMR stewardship and rational use of antibiotics, with conflict of interest (COI) mitigation measures in place. Programmes such as “Sharing Hospital Anti-infectives Perspectives and Experience” (SHAPE) and the “Infectious Disease Education and Learning” (IDEAL) support the implementation of local antimicrobial stewardship programmes. Its COI mitigation strategy consists of external content development and SOPs to review content and potential COIs. The company participates in various interactive courses and massive open online courses (MOOCs) in collaboration with third parties, aiming at changing the behaviour of HCPs in stewardship and resistance.
C.5 Comprehensive involvement in appropriate promotion practices.
The Benchmark measures how companies address stewardship through appropriate promotion. Pfizer reports that it takes action in this regard: it reflects AMR trends in its marketing materials and is currently working on a pilot project to decouple the remuneration of its sales force from sales volume. In addition to providing AMR-related trends in its marketing materials, Pfizer’s materials are reviewed by medical experts to ensure they are aligned with antibiotic stewardship principles. Moreover, sales force training includes topics such as challenges in AMR and stewardship.
C.6 Provides information on treatment duration.
Pfizer adapts its packaging to facilitate appropriate use by providing information on treatment duration. This can help to ensure that patients complete the treatment course.
C.7 Open source surveillance programme.
Pfizer reports that is involved in several surveillance programmes, focused on AMR trends. Pfizer’s ATLAS programme stands out among all AMR surveillance programmes identified by the Benchmark, as it is completely accessible to the public. The company is highly active in surveillance activities globally, some of which have been running for over 14 years. Pfizer reports that it collaborates with public health agencies for its surveillance programme in Latin America.
Animal Health & Diagnostics
Activities in this area are not scored by the Benchmark. This information is provided given the importance of animal health and diagnostics on the topic of AMR.
Pfizer does not market antimicrobials for use in animals.
Pfizer supports COMBACTE-CARE, a European network that addresses the diagnostic challenges for the epidemiological and clinical studies of carbapenem-resistant bacteria. The company has also entered into collaborations with diagnostic manufacturers to support commercial availability of susceptibility tests for its new antibiotics.
* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited.
**Assets, specifically marketed products, acquired from AstraZeneca in 2016, and Basilea in 2017, remain subject to integration into the Pfizer portfolio (including MAA transfer process in several markets). These assets have therefore been excluded from this analysis.
*** Pfizer is involved in the COMBACTE-CDI network, a recently launched project within the IMI COMBACTE research consortium.
† EML Section 6: Anti-Infective Medicines
§ FYE 31 December 2016