In the realm of drug R&D, the dramatic collapse of the antibiotic space – particularly in light of the steady growth of antibiotic resistance – has been evident for years now. And according to analysts at industry group BIO, that hasn’t been a problem with the drug’s success rate at the FDA, where developers in the field have had a relatively high success rate.
The industrial group has published its official press release report on antibiotics this morning, noting new trends in the antibiotics pipeline and the continued exodus of biopharma and investors, all pointing to the market issues at play. And analysts have some urgent suggestions on how to cure the field of what afflicts him.
The report found that venture capital funding for antibiotic investments in the United States over the past decade lags far behind other niche areas – especially when compared to oncology in a report of 17 :1 – totaling $1.6 billion for antibiotics, compared to $26.5 billion for oncology.
And Big Pharma has largely bowed out, since 51 of the 64 antibiotics in development come from small biotechnologies. The other 13 are divided between associations and large companies: 5 and 8, respectively. More than 80% of all FDA antibiotic approvals occurred more than two decades ago, before 2000.
It has been known for some years that companies working on antibiotics have been hurt or bought out, such as with Tetraphase in 2020 for $59 million. In more recent memory, Entasis could exit the Nasdaq pending a takeover bid from Innoviva on the table, and Summit, billionaire Bob Duggan’s antibiotic start-up, faced a Phase III failure at the end. from last year, with a drop of 48%.
The BIO report also noted that between 2011 and 2020, just over 16% of antibiotics in early-stage clinical trials achieved FDA approval – more than double the success rate of 7.9%. across all diseases and more than triple the oncology success rate of 5%.
“What we’re seeing is a very high success rate. So it’s definitely something else, not necessarily the success of the clinic that’s driving companies, or even investors, away. We think it’s a market issue,” said BIO’s vice president of industrial research and report co-author David Thomas. Terminal news.
As Emily Wheeler, director of infectious disease policy at BIO, explained to Endpoints, According to their report, “traditional market dynamics” don’t really apply to antimicrobials – in terms of the broader drug class used as last-line therapy, undervalued and limiting a company’s return on investment.
“New antimicrobials are often used as last resort treatment in hospitals when other options are ineffective. That’s why…the volume of product used is less than some other areas. In addition, they are used for a short duration and experience slow absorption. They’ve still been used sparingly to preserve their effectiveness because the longer you use an antibiotic, the more resistance can develop,” Wheeler said.
The last thing industry, public health or any other stakeholder wants is to misuse or overuse antibiotics and drive up those resistance rates even further. Additionally, we find that antimicrobials are often undervalued for the benefits they provide to patients and society, and so this also suppresses the return a company can make on the product. So really taken together, these challenges create a market with little or no return on investment for these specific antimicrobial drugs.
So what do the potential solutions look like to increase the number of antibiotics on the market? Four types of solutions exist, according to BIO’s report: early-stage investment, late-stage investment, adding regulatory incentives, as well as “market-based mechanisms” such as pull incentives and reform. of the refund.
These include more government funding and grants, such as BARDA, CARB-X, and NIAID, for example. Wheeler also noted a potential model – the Pasteur Bill (Pioneering Antimicrobial Subscriptions to End Upsurging Resistance). This law basically states that a company that develops and gets approved a new product enters into a contract with the US government. The developer would receive an amount ranging from $750 million to $3 billion for a government contract for the antimicrobial molecule in exchange for making its products accessible to certain US government programs. Then again, it’s not tied to how much or how much of that drug is used during the term of the contract, and provides a guaranteed return, according to Wheeler.
Other solutions listed include grants and multi-entity funds for clinical trials.
BIO’s latest solution is a combination of two incentives: a pull incentive to ensure sustainable investment in the antimicrobial resistance (AMR) product pipeline and reimbursement reform to improve patient access.
On the attraction incentive: BIO said that new economic incentives that reward successful innovation at a level sufficient to attract more R&D could serve to bring companies back into the AMR space. Various types of incentives such as market entry rewards and subscription models, such as those proposed in the Pasteur law, have been proposed, but none have been implemented.
Second, the report indicates that reimbursement reform could play a complementary role in stabilizing the antibiotics market, if combined with appropriate valuations. Medicare’s current bundled payment mechanisms may discourage the use of new antimicrobial drugs, writes BIO.
One solution could be for eligible antimicrobials to receive separate payment as part of Medicare reimbursement to the hospital – and could be achieved either through CMS rulemaking or legislation.