GlaxoSmithKline plc

Performance

GSK performs well in all three Research Areas, and is one of the leaders when compared with other large research-based pharmaceutical companies in scope. GSK has the largest antimicrobial R&D pipeline of all large research-based pharmaceutical companies in scope: 55‡ projects, of which 40‡ target priority pathogens, including several novel candidates and 12 new vaccine candidates. It has access and/or stewardship provisions in place for most late-stage candidates. GSK discloses the most comprehensive environmental risk-management strategy of all companies evaluated, which includes discharge limits and reportedly applies to all GSK’s third-party suppliers of antibiotic APIs and drug products, as well as to external waste-treatment plants. GSK has filed its five newest antibiotics for registration in many countries in scope.* It also reports a comparatively broad inter- and intra-country equitable pricing approach for antimicrobial medicines, as well as multiple steps to improve supply chain efficiency. In stewardship, GSK reports that it engages in several AMR education programmes aimed at healthcare professionals, taking action to mitigate conflict of interest in these programmes. It has ceased remunerating sales staff based on sales volume. It engages in AMR surveillance and collaborates and shares its data with public health authorities.

Sales & operations

GSK is a large research-based pharmaceutical company with three divisions: pharmaceuticals, vaccines and consumer healthcare. In 2016, GSK sold the largest volume of antibiotics of all companies in scope of the Benchmark. During 2016, the company’s leading antibiotics were sold in 126 countries, 57 of which were low- and middle-income countries*. In 2009, GSK and Pfizer established ViiV Healthcare, a joint venture solely focused on the development of HIV/ AIDS medicines. Shionogi joined ViiV Healthcare in 2012. Equity positions in ViiV Healthcare are GSK: 76.5%, Pfizer: 13.5% and Shionogi: 10%. In 2015, GSK completed the acquisition of Novartis’ vaccine business (excluding influenza vaccines) and in return divested its marketed oncology portfolio to Novartis. In the same year, GSK sold two of its meningococcal vaccines to Pfizer (Mencevax® and Nimenrix®).

Antimicrobial Portfolio

GSK markets at least 30 antimicrobial medicines, 14 of which are included in the WHO EML (Section 6). The majority of the company’s antimicrobial medicines are established products. Nine of its medicines are antibiotics, including the amoxicillin/clavulanic acid formulation Augmentin™, a 35-year old top-selling antibiotic (by volume). The remainder (21) of the company’s portfolio includes antiprotozoals and anthelminthics, as well as 15 antivirals (12 of which target HIV). The company also markets a chlorhexidine antiseptic gel for umbilical cord care in neonates and has a large and diverse vaccines portfolio, which includes the vaccines Hiberix®, targeting Haemophilus influenzae type B, and Synflorix®, targeting S. pneumoniae.

Opportunities

Develop access plans for gepotidacin. GSK has a stewardship plan in place for its antibiotic candidate (gepotidacin) in late-stage clinical development. GSK can ensure that access plans are also in place for this candidate.

Improve transparency regarding environmental risk management. GSK can build on its current level of transparency, e.g., by adding its Predicted No Effect Concentrations (PNECs) for resistance selection to its safety data sheets. It can also work with suppliers to publish PNECs that apply to its third-party manufacturers of antibiotic APIs and drug products. The company currently publishes several policy documents regarding its environmental risk-management strategy, as well as its safety data sheets. It has also disclosed its PNECs to the Benchmark under a non-disclosure agreement.

Expand on stewardship activities. GSK has established its SOAR surveillance programme for monitoring resistance trends in respiratory tract infections. It can expand this programme to include other diseases and territories, and integrate its activities within existing structures such as WHO’s GLASS programme. GSK has adapted its brochures in South Africa to facilitate the appropriate use of antibiotics by patients. It can expand this practice to more countries in scope* and take further language and literacy needs into consideration.

Expand practices for aligning supply and demand. GSK can work with relevant stakeholders (e.g., suppliers, procurers and payers) to align supply and demand for all antimicrobials, especially for its antibiotics, in countries in scope.* GSK has a general mechanism in place for aligning demand and supply, as well as product-specific mechanisms for five products including albendazole (Zendel®).

A.1 Comparatively high antimicrobial R&D investments. 

GSK reports investments in antimicrobial R&D in 2016, which are high compared to other large research-based pharmaceutical companies in the Benchmark. However, the Benchmark is not able to publish further information, as all details were provided on the basis of confidentiality.

A.2.1-2.3 Largest priority pathogens pipeline, including six novel drug candidates. 

GSK has 55‡ antimicrobial R&D projects in its pipeline, 28‡ of which are in clinical stage development. Forty‡ of the company’s projects target priority pathogens. It has the largest pipeline of the large research-based pharmaceutical companies assessed by the Benchmark, and the highest number of projects that focus on priority pathogens (for both medicines and vaccines). In antimicrobial R&D, GSK’s major focus is on HIV and gram-negative bacteria and, to a smaller extent, M. tuberculosis and gram-positive bacteria. Six out of seven‡ of GSK’s investigational medicines in clinical development (excluding adaptations) are considered novel, making the company’s clinical pipeline the most innovative among large research-based pharmaceutical companies included in the Benchmark. GSK has 11 antimicrobial vaccines in clinical development (excluding adaptations), six of which are developed against diseases caused by a priority pathogen, including HIV, Shigella spp. and non-typeable H. influenzae (for which no vaccines currently exist). GSK is also investigating the development of a meningococcal vaccine (Bexsero®) for protection against gonorrhoea.

A.3 Twenty-four R&D projects being developed with public partners, including eight PDPs. 

GSK is developing 24 R&D projects in its priority pathogen pipeline through public-private partnership.** The company is involved in eight PDPs and one open research consortium, the highest number reported among all companies assessed by the Benchmark. Of these nine projects, seven are in preclinical stage and two are in clinical stage. For the development of its Phase II HIV vaccine, GSK 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 Sanofi. The company also collaborates with Aeras, a non-profit biotechnology organisation, on the development of its tuberculosis vaccine, currently in Phase II clinical development. GSK’s antibiotic candidate gepotidacin is partially funded by both BARDA and the US Defense Threat Reduction Agency under “Other Transaction Authority” (OTA) agreements, which are cost-sharing reimbursement contracts.

A.4 Access and/or stewardship provisions in place for most late-stage candidates. 

GSK reports that it has access and/or stewardship provisions in place for most of its R&D candidates targeting priority pathogens in late-stage development. It has access provisions for 11 out of its 15 antimicrobial candidates in late-stage development. GSK states that it will market its HIV candidates via ViiV Healthcare, which has a general access to medicine policy that includes a commitment to voluntary licensing to allow supplies of generic versions of its products in least-developed, low- and lower-middle income countries and all sub-Saharan African countries. In addition, the policy includes a flexible pricing procedure in middle-income countries that factors in the gross domestic product (GDP) and impact of the epidemic in each country to improve affordability. Furthermore, the company has stewardship provisions in place for seven out of eight of its medicines in late-stage development. Stewardship for GSK’s HIV candidates will be managed by ViiV Healthcare, which sponsors HIV drug resistance surveillance studies that are executed via several independent consortia. Moreover, GSK has a company-wide commitment to decouple sales force incentives from volume of sales, an important stewardship incentive in combating AMR. Only one out of seven of its vaccine candidates has an access provision, while three have an access commitment. For example, the agreement with the nonprofit biotechnology organisation Aeras, for the development of an anti-tuberculosis vaccine includes a global access commitment clause, and WHO prequalification is foreseen. 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.1 Most comprehensive environmental risk-management strategy. 

GSK is the only company in the Benchmark to undertake every environmental risk-management activity that the Benchmark examines. Namely, the company applies an environmental risk-management strategy to minimise the impact of antibiotic manufacturing discharge. It includes auditing and limits on antibiotic discharge, for its own manufacturing sites, third-party manufacturers of antibiotic APIs and drug products, and external waste-treatment plants.

B.2 Limited transparency regarding environmental risk management. 

GSK publishes several of its environmental risk-management policy documents 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. 

GSK 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. GSK requires its third-party suppliers to apply the same quality standards to their production facilities.

C.1 Filed five newest antibiotics in countries in scope. 

GSK leads in this area, as it reports that it has filed its five newest antibiotics for registration in up to 71 countries in scope.* Three of its most recently introduced antibiotics were filed for registration in more than half of the countries in scope.* Its amoxicillin/clavulanic acid antibiotic (Augmentin™) was filed for registration in the highest number of countries in scope* (71). Another two of its antibiotics were registered in nine and 31 countries in scope.* GSK’s five newest antibiotics were introduced between 1981 and 2007.

C.2 Leader in inter- and intra-country equitable pricing.

GSK discloses that it applies an equitable pricing strategic framework to all products including antimicrobials. In addition, it discloses product- specific inter- and intra-country equitable pricing approaches for seven out of nine of its highest-volume antimicrobial medicines. These approaches cover >50% of countries in scope.* For albendazole (Zentel™), GSK has committed to applying intra- and inter-country equitable pricing (including donations) in endemic countries in scope.*

C.3 Taking multiple steps to improve supply chain efficiency. 

GSK engages with WHO and various Ministries of Health of countries in scope* to align supply and demand forecasting for albendazole (Zentel™), aiming to ensure a continuous exchange of information on, e.g., outbreaks. For five of its nine highest-volume antimicrobials, GSK has mechanisms in place to respond efficiently in the event of stock-outs in countries in scope.* These mechanisms include inter-market (e.g., country-level) stock transfers, and for ceftazidime (Fortum®) the prioritisation of emerging markets over established markets.

C.4 Multiple activities in AMR-related educational programmes. 

GSK reports that it is involved in educational programmes for healthcare professionals (HCPs) that include AMR stewardship and rational use of antibiotics, with conflicts of interest (COI) mitigation measures in place. Programmes such as “Surveillance of Antibiotic Resistance” (SOAR) deliver content through ‘active learning channels’ (e.g., conferences and courses) to a broad spectrum of HCPs, such as doctors, pharmacists, and microbiologists. A general COI mitigation policy applies to all of the company’s programmes. Under this policy, GSK no longer pays HCPs to participate in its educational programmes, and uses an external body to select HCPs for sponsorship to attend congresses. Most educational programmes are not product specific. GSK’s commercial teams are, in some cases, not involved in developing materials.

C.5 Comprehensive involvement in appropriate promotion practices. 

The Benchmark measures how companies address stewardship through appropriate promotion practices. GSK reports that it takes action in this regard: it reflects AMR trends in its marketing materials and has decoupled all sales force incentives from sales volumes for all its products. This approach is unique in the industry. The company now remunerates its sales force based on their technical knowledge, and the quality of service they deliver through in-clinic evaluation and monitoring.

C.6 Implements brochure and/or packaging adaptations to facilitate appropriate use.

GSK has adapted its brochures in South Africa to facilitate appropriate use of antibiotics by patients. The company is also developing a digital solution that provides product information to patients, taking illiteracy into account.

C.7 International programme for AMR surveillance. 

GSK runs one international programme, focused on AMR trends for community-acquired respiratory tract infections. The company shares the results with public health authorities, through conferences and multiple peer-reviewed journals. Additionally, the company is collaborating with other organisations (such as the Open Data Institute and the Wellcome Trust) to explore the possibility of developing a single industry-sponsored antibiotic surveillance database, with harmonised measurements and results.

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.

GSK does not market antibiotics for animal use. It has a public policy in place which, states that the company will not license its new antibiotics for agricultural use. While GSK does not have its own diagnostics division, the company reports that it works with third parties to complement AMR product development with diagnostic tests whenever possible. Additionally, the company reports that it provides scientific advice and seed-funding for public-private partnerships and for awards for the development of point-of-care diagnostics to be used in conjunction with antibiotics. GSK also supports COMBACTE-CARE, a European network that addresses the diagnostic challenges for the epidemiological and clinical studies of carbapenem-resistant bacteria.

^{* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited
** GSK is involved in the COMBACTE-CDI network, a recently launched project within the IMI COMBACTE research consortium.
† EML Section 6: Anti-Infective Medicines
‡ GSK3342830 has been terminated after the period of analysis
§ Group turnover; FYE 31 December 2016}