Belgium Developing New Class of Antibiotics, But Incentives and Market Support Needed

Europe’s pipeline of new antibiotics to tackle the growing antimicrobial resistance (AMR) crisis remains inadequate. Belgium is developing a new antibiotic class, but success depends on securing vital support and incentives. 

A recent report by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) reveals that between 2017 and 2023, only ten gained approval, with two deemed innovative by the WHO.

Professor Herman Goossens, an Emeritus Professor of Microbiology at the University of Antwerp, has dedicated three decades to researching antibiotic resistance and influenza pandemics. He outlined to Euractiv the critical need for new antibiotics with innovative mechanisms of action.

However, the challenge says Professor Goossens is that “It’s not very enticing for the pharmaceutical industry, when they invest billions of euros in developing new products, only to find them underutilised due to the risk of resistance. It’s evident that the current business model is flawed.”

He underscored the importance of finding the right incentive structure to drive the development of transformative innovation and retain talent.


Quiet exodus of scientific talent 

For more than two decades, the AMR field has been steadily losing vital scientific and research talent. According to the recent Leaving The Lab report from the AMR Industry Alliance, in recent years AstraZeneca, Novartis and Johnson & Johnson have all “exited or cut back their work on AMR, including closing R&D facilities, selling antimicrobial portfolios, ending AMR development and letting go of research teams.”

The departure of big pharma leaves small and medium enterprises (SMEs) grappling with significant financing challenges. They drive 81% of preclinical projects in the antibacterial pipeline.

The AMR Industry Alliance warns that “by the time the world decides to act on AMR, there may be few researchers and organisations left with the expertise, skills, and infrastructure to deliver the innovation needed to combat the problem.”

Pfizer echoes that if more action isn’t taken to revitalise innovation in this area – a challenge discussed for many years now: “we may find even fewer companies in the space.”

High hopes in Belgium

Belgium’s Santero Therapeutics, a spin-off company from ULB (Université Libre de Bruxelles), is making some progress in early development. Their preclinical research program targets bacteria with innovative methods.

Founding scientists Cédric Govaerts and Abel Garcia Pino told Euractiv: “We believe that our technology could be a game changer in the field, and not another modified old antibiotic drug.”

Santero’s journey exemplifies the delicate balance between push and pull incentives. By securing a total of €11.2 million in private and public funds, the company sustains operations until mid-2025. But to advance clinical proof-of-concept and further develop their pipeline, they require the right mix of pull and push mechanisms.

Tailoring pull incentives

‘Tailored pull incentives’ are essential for attracting pharmaceutical partners to Santero’s compounds. Their business model relies on licensing compounds post-phase 1 clinical trials, necessitating pharma investment.

A potential pull incentive could involve an extension of regulatory data protection (RDP) on medicine from the pharma partner’s portfolio, compensating for limited revenue on the antibiotic. Likewise, the option to sell the right to extend the RDP to another company could also be key to making the incentive attractive.

The cost of innovation

Kevin Outterson, Executive Director of CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), outlines financial hurdles, proposing an incentive range of EUR 1.8 to 4.1 billion to motivate developers. To combat resistant bacteria effectively, robust and sustainable incentives are essential.

Building on Outterson’s research, the EU’s ‘fair share’ of a global incentive, based on relative GDP, amounts to approximately 34% (€1.43 billion) according to a study commissioned by EFPIA, says Andrea Chiarello, Head of EU Government Affairs at Pfizer and Chair of the EFPIA AMR working group.

During the AMR High-Level Meeting hosted by the Belgian presidency on 8 May, EU Health Commissioner Stella Kyriakides outlined key initiatives within the pharmaceutical reform. “These include a transferrable exclusivity voucher (TEV) to promote the development of novel antimicrobials as a matter of urgency.”

She told the audience that the European Commission is also preparing a €17 million EU revenue guarantee mechanism for newly developed antibiotics in the EU to improve the feasibility for producers of these much-needed innovations. “There are options and combinations of push and pull incentives to be explored to effectively address regional, national or global contexts.”

Push and pull debate, real progress

Goossens notes progress in the push-and-pull incentives debate, with Member States favouring an annual revenue model over vouchers. Pfizer’s Chiarello supports the TEV proposal in principle but calls for substantial strengthening to ensure adequate rewards.

Their recently approved antibiotic, which was reviewed under the EMA’s accelerated assessment procedure used when a pharmaceutical product is of major interest for public health and therapeutic innovation – would not be eligible for a TEV under the current European Commission’s proposal as it would not qualify as a ‘priority antimicrobial’.

“We recognise that this is just one treatment in the broader landscape and that it has been successfully brought to market, with support from public-private partnerships. However, it does beg the question, if not this product, then what from the limited pipeline across the industry would qualify within such restricted criteria?”

[By Nicole Verbeeck, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy lab]

date 30/05/2024
source Euractiv
Author Nicole Verbeek