Roche Holding AG
|Applicable indicator||Not applicable|
Roche has relatively low sales of antibiotics compared to the other large research-based pharmaceutical companies in scope. The company is currently making efforts to re-enter the antibiotics market and performs less well in the Benchmark compared to other large research-based pharmaceutical companies. It performs well in Manufacturing & Production, but falls behind in the areas of Research & Development and Appropriate Access & Stewardship. It has a comparatively small antimicrobial R&D pipeline of eight projects, three of which target priority pathogens, including one novel biological antibiotic. Roche discloses a comprehensive environmental risk-management strategy, which includes discharge limits and reportedly applies to all Roche’s third-party suppliers of antibiotic APIs and drug products. Roche, currently actively marketing antibiotics only in China, has filed two of its newest antibiotics in some countries in scope.* It makes no information available regarding equitable pricing for antimicrobials. Roche reports engaging in some stewardship activities, including ad hoc AMR educational activities for healthcare professionals. It provides funding to two surveillance programmes in China.
Sales & operations
Roche is a large research-based pharmaceutical company with two divisions: pharmaceuticals and diagnostics. Its pharmaceutical business includes therapeutic areas such as oncology, neuroscience, infectious diseases and immunology. Although it is the third-largest company in scope of the Benchmark (based on total revenues), its antibiotic sales are low compared to several other large research-based pharmaceutical companies in scope. The company had reduced its antimicrobial research at the turn of the century but has since sought to rebuild it by collaborating with smaller biopharmaceutical companies. Examples include a licensing agreement with Polyphor (ended in 2015), a company also in scope of the Benchmark, and agreements with two different biotechnology companies, Discuva and Warp Drive Bio, for use of their bioinformatics platforms to search for new classes of antibiotics. Roche also develops and commercialises a wide array of point-of-care diagnostic tests for viruses (e.g. HIV, HBV and HCV) and bacteria (e.g., M. tuberculosis, C. difficile and methicillin-resistant S. aureus).
Roche markets at least 11 antimicrobial medicines, seven of which are listed on the WHO EML (Section 6). Two of the company’s antimicrobial medicines are antibiotics, both listed on the WHO EML (Section 6): sulfamethoxazole/trimethoprim (Bactrim®), in the EML’s Access group, and ceftriaxone (Rocephin®), in both the Access and Watch groups. The remaining nine medicines are two antiprotozoals and seven antivirals (including one PEGylated and one non-PEGylated interferon for the treatment of viral hepatitis).
Plan ahead for access and stewardship during R&D. Roche has two candidates in clinical development, both in Phase I. Roche is encouraged to implement access and stewardship plans for these candidates as they move into Phase II clinical development.
Ensure access by addressing affordability for antimicrobial medicines. Roche has reported that it has low-priced generic antibiotics available on the market, and that the price of its originators has also decreased. Roche can improve the affordability of its antimicrobial medicines by developing an equitable pricing strategy that takes socio-economic factors into account.
Engage in antimicrobial stewardship. Roche currently supports some education and surveillance programmes. It can engage more actively in stewardship activities, e.g., through strengthening its role in more surveillance activities, educational activities for healthcare professionals on AMR (while mitigating conflicts of interest) and engage in appropriate promotion practices.
Improve transparency regarding environmental risk management. Roche can share more information on how it manages environmental risk, e.g., disclose the levels of antibiotic discharge and publish the identities of third parties who manufacture antibiotic APIs and drug products on its behalf. Roche currently discloses several policies on environmental risk management.
Expand environmental risk-management strategy. Roche has set discharge limits for its own and third party manufacturing sites as part of its environmental risk-management strategy. Roche can ensure these discharge limits are applied to its external waste treatment plants.
A. Research & Development
8 projects, 3 target priority pathogens
A.1 No information on antimicrobial R&D investments.
Roche reports no information on its antimicrobial R&D investments.
A.2.1-2.2 One novel biological agent in the clinical pipeline.
Roche has eight** antimicrobial R&D projects in its pipeline, seven of which are in clinical stage development. Three of the company’s projects target priority pathogens, the lowest number of projects targeting priority pathogens among large research-based pharmaceutical companies. However, all three of these projects are focussed on bacteria. Roche also focusses its R&D activities on influenza and hepatitis B. The company has at least one project in preclinical stage.*** Roche is developing an antibody-drug conjugate, a novel antibody bound to a rifamycin analogue, against S. aureus. It is a highly specific and innovative biological agent. Additionally, Roche is developing a new s-lactamase inhibitor, nacubactam, which is currently in Phase I clinical development. Roche is engaged in a collaborative antibiotics discovery project with drug discovery company Discuva. This collaboration involves the use of Discuva’s proprietary SATIN technology platform, a novel technology that identifies the molecular targets of chemical compounds that affect bacterial growth and genes. The platform comprises several different varieties of transposons — genes that are specifically engineered for each target pathogen, coupled with high-throughput Next Generation Sequencing (NGS) technology, bioinformatics and machine learning. This allows for ongoing genome-wide analysis of bacterial events throughout the chemistry optimisation process. Roche does not have any drug candidates targeting a priority pathogen beyond Phase II of clinical development.
A.3 One R&D project being developed with public partners.
oche is developing one R&D project in its priority pathogen pipeline through public-private partnership. The company received funding from BARDA (potentially up to USD 150 mn) to further develop its s-lactamase inhibitor nacubactam and accelerate the development of tests for detecting specific viral and bacterial infections. Roche also conducts R&D with private-sector partners.‡
A.4 No R&D candidate in late-stage development.
Roche is not eligible for this indicator as it does not have any R&D candidates in late-stage development.
Pipeline targeting priority pathogens
B. Manufacturing & Production
B.1 Comprehensive environmental risk-management strategy.
Roche undertakes almost all 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, both for its own manufacturing sites and those of third-party manufacturers of antibiotic APIs and drug products. Roche states that its strategy applies to external waste-treatment plants, yet it also reports that it does not set discharge limits for these plants nor audits implementation of the strategy.
B.2 Limited transparency regarding environmental risk management.
Roche 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.
Roche 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. Roche 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 two newest antibiotics in some countries in scope.
Roche has provided filing information on two of its newest antibiotics: ceftriaxone (Rocephin®) was introduced in 1984 and has now been filed for registration in 49 countries in scope.* Sulfamethoxazole/trimethoprim (Bactrim®) was introduced in 1969 and has now been filed for registration in 34 countries in scope,* mainly in Latin America and sub-Saharan Africa.
C.2 No equitable pricing approach.
Roche does not disclose an equitable pricing approach for its highest-volume antibiotics and/or antimicrobial medicines. It does report that it views competition from generic medicines as the main mechanism triggering price reductions.
C.3 No insight into steps addressing supply chain efficiency.
Roche 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 stockouts in countries in scope*. The company also does not report on whether it has processes in place to respond to stock-outs in countries in scope.* After the period of analysis, Roche reported to the Benchmark that it does have a global expert group to allocate available supply to prevent stock-outs from happening.
C.4 Some involvement in AMR-related education.
Roche has provided information for its China headquarters, the only country where it actively markets antibiotics. The company reported that its China headquarters provides on-demand educational materials for rational use of antibiotics for self-learning purposes, but stated that due to limited resources, it does not initiate educational programmes independently.
C.5 No involvement in appropriate promotion practices.
The Benchmark measures how companies address stewardship through appropriate promotion. The company does not report taking action in this regard either through reflecting AMR trends in its marketing materials or decoupling its sales force’s incentives from volume of antibiotic sales. Roche has only provided information for the antibiotic ceftriaxone (Rocephin®), which is used in community-acquired infections. The company reports that it only actively markets and promotes this antibiotic in China.
C.6 No information regarding brochure and/or packaging adaptations.
Roche does not provide sufficient information on linguistic, cultural or literacy adaptations made to its brochures or packaging to facilitate appropriate use of antibiotics by patients.
C.7 Supports academic surveillance programmes financially.
Roche has only provided information for surveillance activities taking place in China, the only country where it actively markets antibiotics. The company supports two surveillance programmes focussed on AMR trends in China. It provides funding for these two programmes, which focus on community-acquired E. coli and pneumonia infections in secondary and tertiary care hospitals in China. The sharing of the results from these studies is the sole responsibility of the researchers; however, the leading researchers have stated plans to publish the results in peer-reviewed journals.
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.
Roche develops and commercialises a wide array of diagnostic tests for viruses (e.g., HIV, HBV and HCV) and bacteria (e.g., M. tuberculosis, C. difficile and methicillin-resistant S. aureus). For example, the cobas® Liat® system is an in vitro diagnostic platform where results can be made available in less than 30 minutes for viruses (e.g., influenza A/B) and bacteria (e.g., C. difficile). Additionally, since 2014, Roche has partnered with UNAIDS and the Clinton Health Access Initiative (CHAI), among others, to help diagnose and combat HIV infections in children and adults in 82 developing countries with a high burden of disease.
* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited
** After the Benchmark’s period of analysis, Roche reported termination of one of these projects (MHAA4549A)
*** After the Benchmark’s period of analysis, Roche entered into collaboration with Warp Drive Bio around the Genome Mining™ Platform, which provides access to over one hundred novel classes of natural antibiotics.
† EML Section 6: Anti-Infective Medicines
‡ After the Benchmark’s period of analysis, Roche reported having 13 active research collaborations with academic groups globally to support novel antibiotic discovery focussing on multidrug-resistant gram-negative bacteria
§ Revenues from external customers, inc. sales, royalties and other operating income; FYE 31 December 2016
|| Sales; FYE 31 December 2016