Largest proportion of pipelines dedicated to priority R&D projects
More than 60% of GSK’s and Sanofi’s pipelines focus on diseases for which vaccines, medicines and diagnostics are urgently needed, yet either ineffective or lacking.
To develop medicines, vaccines and diagnostics that are urgently needed, particularly by people living in low- and middle-income countries.
The WHO and Policy Cures Research have identified which R&D targets are the most urgent priorities when it comes to tackling major diseases such as malaria, tuberculosis and others.
There are many diseases without adequate or effective treatments available, or where the products are not sufficiently tailored to meet the needs of people living in low- and middle-income countries. Pharmaceutical companies have much to add in this space. Addressing such ‘product gaps’ is a core expertise of the industry. In 2018, the Index has deepened its analysis of R&D that addresses such gaps, looking specifically at the diseases listed on five priority R&D lists currently published and accepted by the global health community from WHO and Policy Cures Research. This is termed ‘priority R&D’ by the Index.
Two companies stand out among pack
GSK and Sanofi demonstrate best practices in this area. Both are leaders by the proportion of priority R&D projects in their pipelines to address specific gaps identified by WHO and Policy Cures Research, an independent R&D-focused policy group.
How does GSK demonstrate best practice?
GSK has 86 projects in its R&D pipeline for diseases in scope, and 58 of these (around 67%) address priority R&D gaps. The majority relate to products for HIV/AIDS and priority pathogens (specific strains of bacteria that have demonstrated resistance to certain antibiotics, making treatment particularly difficult).
Other projects address malaria and maternal and neonatal health conditions, including maternal and neonatal sepsis and maternal haemorrhage. Of GSK’s 58 priority projects, 34 are medicines, 23 are preventive vaccines and one is a vector control project for malaria. Two projects cover multiple product types.
To close product gaps and to achieve a public health impact, companies must keep priority R&D projects moving through the pipeline. They also need to establish access plans to ensure people can access and afford products in countries in scope as soon as possible. GSK performs well in both progressing projects through the pipeline and establishing access plans for its priority R&D projects. Of its 58 priority R&D projects, 34 (58.6%) have access plans in place, with 15 progressing in the pipeline during the period of analysis. Four of these have received market approval: two influenza vaccines with paediatric indications, a multi-dose pneumococcal polysaccharide conjugate vaccine (Synflorix®), and the first single-tablet, two-drug complete antiretroviral therapy: dolutegravir/rilpivirine (Juluca®).
A fifth project, tafenoquine (Krintafel™) for Plasmodium vivax malaria, was submitted for market approval during the period of analysis and received this on 20 July 2018. All five products address critical health needs in low- and middle-income countries, and in each case, plans have been made during R&D to help ensure these products will be accessible. For example, dolutegravir/rilpivirine (Juluca®) has registration and equitable pricing strategies, and GSK plans to apply non-exclusive royalty-free voluntary licensing to the product.
How does Sanofi demonstrate best practice?
Sanofi also performs well in ensuring that its priority R&D projects have access plans in place during development. Of its 56 R&D projects, 35 (62.5%) are priority projects addressing specific product gaps identified by WHO and Policy Cures Research, with an emphasis on lower respiratory infections, tuberculosis and malaria. Seven projects target neglected tropical diseases (NTDs), particularly Chagas disease, leishmaniasis and human African trypanosomiasis. Like GSK, Sanofi’s 35 priority projects target a range of diseases and product types: 19 are for medicines, and 16 are for preventive vaccines.
Two fifths (14/35) of Sanofi’s priority R&D projects are late-stage, including seven Phase III clinical candidates. One of these clinical candidates is fexinidazole, which could become the first oral treatment of human African trypanosomiasis caused by Trypanosoma brucei gambiense, as a result of a 10-year collaboration with the Drugs for Neglected Diseases initiative (DNDi). Sanofi has established access plans for 21 of its 35 priority R&D projects. In the majority of cases, these include plans to apply for WHO prequalification. One example of the way Sanofi makes effective use of WHO prequalification for priority R&D projects is its oral cholera vaccine Shanchol™. While this has not yet received approval from a stringent regulatory authority such as the FDA, Sanofi has shipped more than 12 million doses of the vaccine globally since receiving WHO prequalification in 2011. Data from WHO prequalification has played an important role in countries’ decisions to allow the vaccine to be used by its citizens. With updated WHO approval in February 2018, the vaccine can now be kept in conditions that limit the need to maintain a cold chain, which can be particularly challenging in resource-limited settings.