|Applicable indicator||Not applicable|
Sanofi is among the top performing large research-based pharmaceutical companies in scope, following close behind the leaders. This is driven by strong performance in Research & Development with average performance in Manufacturing & Production and Appropriate Access & Stewardship. The company’s R&D pipeline consists of 32‡ antimicrobial projects, of which 18‡ target priority pathogens, including one novel antimalarial candidate and six new vaccine candidates. It has access provisions in place for three out of five of its vaccines in late-stage development. Sanofi discloses a comprehensive environmental risk-management strategy, which reportedly applies to all the company’s third-party suppliers of antibiotic APIs and drug products, as well as mechanisms to assure quality of antibiotic manufacturing is maintained. Sanofi reports that it has filed its five newest antibiotics in some countries in scope.* The company engages in equitable pricing strategies on non-antibiotic antimicrobials only. Sanofi reports having mechanisms in place for responding efficiently to stock-outs in countries in scope.* The company engages in a number of AMR educational activities, as well as surveillance programmes.
Sales & operations
Sanofi is a large research-based pharmaceutical company organised into five business units: general medicines and emerging markets; diabetes and cardiovascular; consumer healthcare; specialty care; and vaccines. Its specialty care business unit develops treatments for rare diseases, multiple sclerosis, oncology and immunology. The company sells antimicrobial medicines and vaccines in 140 countries globally, including 72 low- and middle-income countries.* Sanofi’s vaccine business is run via subsidiary Sanofi Pasteur. In 2016, the company sold more than 1 billion doses of vaccines globally. At the end of 2016, Sanofi Pasteur and Merck & Co., Inc. ended their vaccines joint venture in Europe (Sanofi Pasteur MSD, established 1994) to independently manage their product portfolios. At the same time, the company completed the acquisition of Boehringer Ingelheim’s consumer healthcare business, in exchange for its animal health business (Merial).
Sanofi markets at least 31** antimicrobial medicines, 18 of which are listed on the WHO EML (Section 6). Twenty-one of the company’s antimicrobial medicines are antibiotics, with 11 listed on the WHO EML (Section 6), including five in the EML’s Watch group. The remainder (ten) of the company’s portfolio consists of antiprotozoal medicines, including seven indicated for the treatment of malaria. Its vaccines portfolio is one of the largest of the companies assessed by the Benchmark and covers a wide range of indications, including pneumococcal disease (Pneumo™ 23), meningococcal disease (e.g., Menomune®) and infections caused by Haemophilus influenzae type B (ActHib®).
Plan ahead for access and stewardship during R&D. Sanofi discloses no information regarding access and stewardship provisions for its antimicrobial medicines in late-stage clinical development. For its vaccine candidates, it plans to, e.g., apply for WHO prequalification. Sanofi can implement further access and stewardship plans for all its candidates in late-stage clinical development.
Increase engagement in stewardship activities. Sanofi engages in some stewardship activities. Sanofi can take steps to ensure that its current AMR educational activities for healthcare professionals include processes to mitigate conflicts of interest. It can also expand its current surveillance activities to more countries, collaborating with public health authorities and ensuring that the data is made publicly available via an open database. Sanofi can also engage in appropriate promotion practices.
Ensure access by addressing affordability for antimicrobial medicines. Sanofi currently states a commitment to applying product-specific inter-country equitable pricing to two of its antimicrobial medicines. Sanofi can seek to improve access for more antimicrobial medicines (specifically antibiotics) by expanding its affordability strategy to more products and more countries in need.
Improve transparency regarding environmental risk management. Sanofi can share more information on how it manages environmental risk, e.g., disclose the levels of antibiotic discharge, and publish the identity of third party manufacturers of antibiotic APIs and drug products. Sanofi currently discloses several policies on environmental risk management.
Expand environmental risk-management strategy. Sanofi has set discharge limits for its own manufacturing sites as part of its environmental risk-management strategy. It can ensure these discharge limits are applied to third parties who manufacture APIs on its behalf, as well as to external waste-treatment sites.
A. Research & Development
32 projects, 18 target priority pathogens
A.1 Comparatively high vaccine R&D investments.
Sanofi reports that it invested more than USD 500 million in the development of vaccines in 2016, which is high compared to other large research-based pharmaceutical companies in the Benchmark. The company reports no information on investments made for the development of antimicrobial medicines.
A.2.1-2.3 Eighteen R&D projects in priority pathogen pipeline, with broad focus.
Sanofi has 32‡ antimicrobial R&D projects in its pipeline, 19‡ of which are in clinical stage development. Eighteen‡ of the company’s projects target priority pathogens. Its pipeline size is above average when comparing it to other large research-based pharmaceutical companies assessed by the Benchmark. Its pipeline covers a broad range of priority pathogens, including both gram-negative and gram-positive bacteria, HIV, P. falciparum (malaria) and M. tuberculosis. Looking only at R&D for multidrug-resistant bacteria, the company has seven discovery- stage projects, one vaccine in preclinical stage and three vaccines in clinical development, including one that targets M. tuberculosis. The company has one novel antimalarial medicine in clinical development (artefenomel/ferroquine), in collaboration with the Medicines for Malaria Venture (MMV). Ferroquine is a promising ferrocene- containing compound active against both chloroquine-susceptible and chloroquine-resistant P. falciparum, while artefenomel displays important chemical dissimilarities to other artemisinins, making it likely to remain effective against artemisinin-resistant strains. Six out of 12 of Sanofi’s innovative vaccines in development target priority pathogens. Four of these are clinical-stage projects, including an HIV vaccine candidate (for which no vaccines currently exist).
A.3 Eleven R&D projects being developed with public partners, including seven PDPs.
Sanofi is developing 11 R&D projects in its priority pathogen pipeline through public-private partnerships (including non-profit organisations).*** Eight of these R&D projects are in development through a PDP or open research consortium. Seven projects are in development through a PDP, five are in preclinical stage and two are in clinical stage. For the development of its Phase II HIV vaccine, Sanofi partners with the Pox-Protein Public Private Partnership (P5), a project that includes the US National Institute of Allergy and Infectious Diseases (NIAID), the Bill & Melinda Gates Foundation, the South African Medical Research Council, the HIV Vaccine Trials Network (HVTN), the US Military HIV Research Program and GSK. The company also collaborates with Aeras, a non-profit biotechnology organisation, on the development of its tuberculosis vaccine, currently in Phase II clinical development. The remaining three R&D projects (two preclincial, one clinical) involve public research institutes.
A.4 Access provisions in place for most vaccines in late-stage development.
Sanofi reports that it has access provisions in place for three out of five of its vaccines in latestage development. It reports that it has an access commitment in place for its antimalarial candidate in late-stage development, but does not report information on access provisions. For its three vaccines in late-stage development, Sanofi plans to file for WHO prequalification and/or for the European Medicines Agency (EMA) article 58 (a scientific assessment of a medicine for use outside the EU). For the antimalarial candidate in late-stage development (artefenomel/ferroquine), the company commits to ensuring sufficient supply, but does not provide a clear strategy for achieving this goal. For this indicator, countries in scope are 106 low- and middle-income countries where access to medicine is likely limited. Regarding stewardship provisions, Sanofi signed the Davos Declaration, which includes a general commitment to support the appropriate and responsible use of antimicrobial medicines and vaccines.
Pipeline targeting priority pathogens
B. Manufacturing & Production
B.1 Comprehensive environmental risk-management strategy.
Sanofi undertakes almost all 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 for its own manufacturing sites and those of third-party manufacturers of antibiotic APIs and drug products, and for external waste-treatment plants. Sanofi has also set antibiotic discharge limits for its own manufacturing sites.
B.2 Limited transparency regarding environmental risk management.
Sanofi 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.
Sanofi 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. Sanofi 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 five newest antibiotics in some countries in scope.
Sanofi reports that it has filed its five newest antibiotics, introduced between 1989 and 1997, for registration in some countries in scope* (between 20-45 countries). Two of these antibiotics are on the WHO EML (Section 6): cefixime (Oroken®), which is registered in 20 countries mainly in sub-Saharan Africa; and levofloxacin (Tavanic®), which is registered in 45 countries across multiple regions.
C.2 Inter-country equitable pricing for antimicrobials.
Sanofi discloses inter-country equitable pricing approaches for two of its highest-volume antimicrobial medicines in some countries in scope.* The two approaches cover: (1) meglumine (Glucantime®) indicated for Leishmaniasis, mainly in Latin American countries; and (2) amodiaquine/ artesunate (ASAQ Winthrop®) indicated for malaria, mainly in Africa. For amodiaquine/ artesunate, the pricing approach is being implemented in cooperation with partners such as the Global Fund, WHO and MSF.
C.3 Global mechanisms in place for responding to stock-outs.
Sanofi reports that it has global mechanisms in place for responding efficiently to stock-outs of its antibiotics and non-antibiotic antimicrobial medicines. The company demonstrates no evidence of engaging with relevant stakeholders (e.g., governments, procurers) to align the supply and demand for antimicrobial medicines. It does report informing and following-up on stock-outs with local or regional authorities.
C.4 Some involvement in AMR-related education.
Sanofi reports that it is engaged in several educational activities, focusing on infectious disease management and appropriate use and prescription of antibiotics, running e.g., in France, China, India and Vietnam. Content is delivered via websites, conferences and meetings to a wide range of healthcare professionals, including medical doctors, microbiologists and pharmacists. It is not clear, however, how the company ensures content is developed independently or how it mitigates possible conflicts of interest.
C.5 Adopts some appropriate promotion practices.
The Benchmark measures how companies address stewardship through appropriate promotion practices. Sanofi reports that it takes action in this regard by reflecting AMR trends in its marketing materials, including information about resistance trends and guidelines in its non-product-specific materials. However, the company’s appropriate promotion practices do not include the decoupling of its sales force’s incentives from volume of antibiotic sales.
C.6 Provides information on treatment duration.
Sanofi adapts its packaging to facilitate appropriate use of antibiotics by patients, by providing information on treatment duration. This can help to improve patient adherence to treatment.
C.7 Public health partnership to monitor AMR trends in France.
Sanofi is engaged in one surveillance programme. Sanofi partners with public health institutions to monitor AMR trends in France, for example. Sanofi cooperates with French national institutes in the monitoring of antimicrobial resistance trends. The company does not own the data, and depends on its partners to publish results in journals or at congresses.
* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited.
** Sanofi provided only a sample (approx. 50%) of its global antimicrobial portfolio.
*** Sanofi is involved in the COMBACTE-CDI network, a recently launched project within the IMI COMBACTE research consortium.
† EML Section 6: Anti-Infective Medicines
‡ C. difficile vaccine has been terminated after the period of analysis.
§ Net sales not inc. the held-for-exchange Animal Health segment; FYE 31 December 2016