Sanofi announced last week that they are shedding off their anti-infectives Research & Development unit. This is surprising as Sanofi was a leading partner of the AMR Industry Alliance and raises questions on the level of commitments made. With big pharmaceutical companies outsourcing Research & Development, it sparks the need to ensure that incentives models target the actors actually involved in Research & Development.
Last week the news came that the definitive agreement between Sanofi and Evotec has been signed. The deal between Sanofi and the German biotech company Evotec was first communicated in March this year, and after required legal procedures the deal has now been sealed. Sanofi will license more than 10 anti-infectives to Evotec and transfer its infectious diseases Research & Development (R&D) unit. Evotec will take on around 100 staff members and receives a one-time, upfront payment of 60 million euros from Sanofi. The deal does not include Sanofi’s vaccine portfolio or its vaccine R&D unit.
Departing from previous commitments
The agreement is part of Sanofi’s strategic focus towards cancer, diabetes, cardiovascular diseases, vaccines and rare diseases. This shift in focus seems at odds with Sanofi’s previous commitments to contribute to tackling antimicrobial resistance (AMR), as signatories of the AMR Industry Declaration at the World Economic Forum in Davos in January 2016. Sanofi was also a leading partner in The Roadmap of September 2016, outlining a common set of actions for the members of the AMR Industry Alliance to deliver on.
Through the AMR declaration and Roadmap, over 100 companies committed themselves to invest in Research & Development to meet public health needs of: diagnostics and treatments, reducing the development of antimicrobial resistance, improving access to high-quality antibiotics, vaccines and diagnostics, and reducing the environmental impact of manufacturing.
So far, the news seems to have gone largely unnoticed and uncommented by the wider AMR community. This is somewhat surprising given the central role that Sanofi has played in the development of the AMR Declaration and Roadmap. Earlier this year only 36 of 101 Alliance member companies actually participated in the survey for the Alliance’s first progress report done by the consultancy SustainAbility.
This recent step taken by Sanofi should raise broader questions about what level of actual commitment that lies behind the Industry AMR Declaration and Roadmap. It seems like an obvious area of further analysis for the Access to Medicines Index to engage in for their next iteration of the AMR Benchmark given that it is based on exactly these public commitments made by the industry actors.
Evotec taking over – Sanofi retains rights
Evotec, part of Novo Holdings and a drug discovery alliance and development partnership company, will create an innovation platform on antimicrobial resistance in Lyon, open to pharmaceutical and biotechnology companies, foundations, academia and government agencies. They already have a number of other R&D initiatives with in-licenses from other companies and collaborators.
Under the new agreement, Sanofi will continue to have certain option rights on the development, manufacturing and commercialization of the anti-infective products. Evotec has additional anti-infective assets in its development pipeline. Through different agreements, Evotec progress pre-clinical assets and builds partnerships with drug discovery alliances and pharmaceutical companies. In the case with Sanofi, Enotec will be paid up front to cover costs of staff and R&D and Sanofi takes the financial risk of the development.
Opportunity for system shift?
The outsourcing of an entire Research & Development unit is an example of how big Research & Development pharmaceutical companies are stepping away from being involved in the actual research and development of new antibiotics.
The pipeline of new antibiotics could instead mainly be driven forward by biotech and collaborators, potentially in collaboration and with financial support of partnership initiatives such as GARDP, CARB-X and ENABLE. Often several parts in the clinical development phase are already being outsourced to Clinical Research Organisations (CROs), who support manufacturers on the path to develop and approve drugs.
What is needed?
For policy makers, this recent announcement should cause pause for thought in the broader incentives debate which has disproportionately focused on developing big Market Entry Rewards for big pharmaceutical companies.
Any public investments that are mobilized to support antibiotic Research & Development should instead be targeted towards the actors that are actually involved in Research & Development activities and should be guided by public needs and aligned with global priorities. Such investments should ensure a return on public investment and should enable de-linkage whereby Research & Development investments are separated from sales volumes and high prices to promote affordable access and ensure controlled use and distribution of novel antibiotics. Only this way can affordable access and public health driven stewardship policy measures be realized that create new solutions to otherwise untreatable infections.