New BIO report predicts uncertain future for antibiotics sector

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A new report examining the landscape of antibiotics in the United States has underscored the need for public policy solutions as investment in the sector declines and major drugmakers leave space.

The report, ‘The state of innovation in antibacterial therapeutics‘, published by the Biotechnology Innovation Organization (BIO) this week, underscores the need to improve innovation in the antibiotic sector. According to the report, the most crucial policy reforms are those that address the beleaguered antibiotic market.

According to the report authors, the current antibacterial pipeline is insufficient to address the threat of drug-resistant infections, and antibiotic discovery needs to be expanded to address new targets. Of the 72 antibacterial drug programs currently underway, more than 38% target It’s hard and tuberculosis, leaving only 44 drugs indicated for other pathogenic bacteria.

Many antibiotics already on the market will become less effective due to antimicrobial resistance (AMR), the report says, and there needs to be a “well-funded and appropriately rewarded biotech ecosystem” to enable the development of new antibacterial drugs to fill the gap. the void.

In addition to the shrinking pipeline of new antibiotics, approvals have slowed over the past few decades; more than 82% of all antibiotics approved by the FDA were approved before 2000. The report authors also note that in the past 35 years, only one antibiotic with a new molecular target or mechanism of action has been approved by the regulator.

BIO’s President and CEO, Dr Michelle McMurry-Heath, said: “More than one million people around the world lost their lives to drug-resistant bacteria in 2019. We urgently need effective new antimicrobial drugs to address ever-increasing resistance.

All is not bad, however. Contrary to the report’s largely bleak findings, BIO calculated that the overall success rate of new antibacterial chemical entities (NCEs) – from Phase I to FDA approval – was 16.3%, significantly above average. of industry by 7.9%.

Falling investment

While the number of new antibiotics coming to market has declined in recent years, investment in space has also declined. Over the past decade, U.S. companies focused on antibacterials have received $1.6 billion in venture capital funding, compared to $26.5 billion for oncology.

Over the past 10 years, while initial public offerings (IPOs) for 12 U.S. antibiotic biopharma companies totaled just $700 million, 109 U.S. oncology companies raised $12 billion, meaning companies antibiotic companies received nearly 17 times less funding than cancer-focused companies.

BIO says the $2.3 billion raised by antibiotic-focused start-ups over the past decade, both through venture capital and IPOs, is not enough to offset the broader ecosystem and the diverse pipeline candidates the industry needs.

The organization offers three main reasons why investors have avoided antibacterial development: the majority of biotechnology products receiving FDA marketing approval have ended in commercial failure; there is a lack of policy and regulatory solutions that address antibiotic market challenges; and major pharma companies have been leaving space for years.

Need for political solutions

The report suggests a number of steps that can be taken to increase investment and innovation in the antibiotics sector. The solutions, the report says, are interconnected and dependent on each other.

First, there must be early-stage investments and incentives in antibiotic research by governments, philanthropic foundations and institutes. Creative hybrid funding models can encourage the early development of promising new drugs – the global nonprofit CARB-X partnership, for example, provided $360 million in funding for 92 projects in 12 countries over a five-year period .

There must also be late-stage investments to support small companies with promising candidates as they enter costly and complex Phase II and III trials. The report cites the US Biomedical Advanced Research and Development Authority’s Project BioShield and Broad Spectrum Antimicrobials programs as examples of public-private partnerships that can help accelerate research and development of late-stage investigational products.

Regulatory measures that address key challenges, such as recruiting trials and conducting large and complex comparative efficacy studies, need to be introduced to minimize the hurdles faced by antibiotic developers.

The bipartisan Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, a policy proposal currently before Congress, seeks to establish a subscription model under which drugmakers would receive agreed-upon annual amounts based on the clinical need and novelty of their drug.

To address the unique challenges of the antibiotics market, there must be “an incentive to pull to ensure sustainable investment in the antimicrobial product pipeline and reimbursement reform to stabilize the commercial market and improve patient access.” The report says one solution is to have separate payments for antimicrobial drugs as part of Medicare hospital reimbursement. The move would ensure that hospitals are properly reimbursed for these drugs and that the necessary antimicrobial is prescribed “based on clinical, not financial, considerations.” Reimbursement reforms such as this would ensure patients’ access to new antibiotics, when needed, and address the low market appeal of antimicrobial drugs, the report says.

David Thomas, Vice President of Industrial Research at BIO and one of the report’s authors, said, “Robust innovation in this area is absolutely essential to combating the global threat of antimicrobial resistance, and we believe that public policy solutions are needed to realign market incentives and encourage more innovation.

The Exodus of Big Pharma

With only four major drugmakers remaining in the space, antibiotic research has been effectively abandoned by big pharma. Pharmaceutical giants Novartis, Sanofi and AstraZeneca have all announced their departure from the sector in recent years, opting instead to focus their efforts on more lucrative areas of research.

Of the antibacterial candidates currently in development, 80% come from small emerging biotech companies. BIO’s report warned that as funding for these drugmakers dwindles, the sector risks losing the companies driving much-needed innovation in the space.

According to BIO, 12 antibiotic companies have gone public in the past decade – and only five remain active today. Big pharma has traditionally been essential to the antibiotic ecosystem, the report says, offering “extensive manufacturing infrastructure and global distribution capability.”

While small companies leading the field of antibacterial drug discovery and development offer the promise of new antibiotic candidates, the exodus of big pharma leaves its future uncertain.

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