The progress in developing therapies and vaccines for COVID-19 has been extraordinary, and has received extraordinary attention.
But there’s another good news story beginning to emerge, about our widening array of defenses against bacterial infectious disease.
On the clinical front in the past month, developers have announced positive Phase III trials in difficult diseases that have been marked with prior failure, such as C. Difficile gut infections and oral treatment of resistant, complex urinary tract infections (cUTI). As we have noted before in this column, the continued growth and sustainability of the antibacterial field depends on choosing medicines that have a high prevalance of unmet need and sustainable reimbursement in the current system (typically outside of the hospital DRG based payment system).
Those things are necessary to build a base upon which to develop new treatments for emerging diseases.
For infections (primarily hospital-based) that require reimbursement reform before we can develop economically sustainable treatments, the reintroduction of the PASTEUR Act last month in Congress is a welcome step in planning for our preparedness against future pandemics and infectious threats.
The Act would confer substantial upfront payments and payments over time (totaling hundreds of millions of dollars) to sponsors developing agents to treat current and future high-priority bacterial threats. This could provide the kind of steady, predictable revenue streams for future infectious threats that don’t exist in the market today.
Where do we go from here? The impact of infection, even at the highest levels of government, makes the wait for vaccines and therapeutics excruciating.
Certainly, a comprehensive, long-term approach to developing medicines for current and future threats before they’re in dire need is critical. Further, as an important part of the economy and the social infrastructure that supports it, the drug development community must be a driver in this solution as it has been with COVID-19, rather than waiting for someone else or another pandemic to propel us into action.
Each of us in the ecosystem has a part to play to keep driving ahead towards a solution in advance, so we won’t be stuck playing catch-up.
Drug Developers: Continue the focus on right drugs for right patients
Those of us that select and prioritize investment in infectious disease portfolios have the highest responsibility to choose therapeutic needs that meet two related priorities: address a need currently not met by existing medications and have the economic potential to sustain a franchise.
Medicines reimbursed outside of the hospital tend to meet these criteria (see here for much more data behind a premise for a sustainable franchise).
When a company can generate enough product revenue to achieve scale, it then has the means to plow profits back into additional promising therapies. Cubist Pharmaceuticals (built based on the growth of daptomycin in the outpatient setting) and Pfizer (built in part on the growth of linezolid in the outpatient setting) are models for success.
When building off a stable foundation as in these cases, antibacterial developers can have enough wherewithal to acquire additional revenue-generating products, take advantage of some of the substantial regulatory and market exclusivity incentives that exist in this category, and fulfill our industry’s mission to be a source of cures for the most pressing needs of the moment and in the future.
Large Pharma: Build on a great start
The commitment of over $1 billion to the infectious disease sector by a consortium of larger companies, through the Antimicrobial Resistance (AMR) Action Fund, is a great start.
However, money by itself isn’t enough. Given that drug development is the answer to the challenge nature has posed to us with infectious threats, larger drug developers can continue to be central by directly advancing medicines.
The approach of being reactive to threats as they emerge is suboptimal, as evidenced by today’s pandemic. As with biotech, the first step is building these efforts around applications that have economic potential in the current health care environment and can form the basis for efforts at greater scale.
Recent investments by Roche and Pfizer, continuing investment in the field by Merck, as well as interest from new parties are positive developments. There’s also an increasing recognition of the opportunity to do well for shareholders and patients by using sustainable products to build a base for a pipeline.
Policy makers: Keep up the good work via BARDA
It’s heartening to see the multiple, well thought-out proposals in legislatures around the world for investing in new anti-infectives. What’s required now is for all stakeholders to coalesce around the right solutions. No plan will be 100% perfect for all stakeholders, but doing nothing will certainly be imperfect for all of us.
In the meantime, the Biomedical Advanced Research and Development Authority (BARDA) has risen to the challenge of the COVID-19 response. It has also remained focused on infectious threats beyond COVID-19, marshaling its expertise, mandate, and national coordinating platform.
All of us
We can choose what we value in the health care system. Ultimately, all actors in our health care system follow the incentives created by reimbursement. Our industry has a vast number of pipeline medicines in play (many around the same targets) in oncology, rare diseases, and inflammation.
That is because our system — either intentionally or unintentionally — puts more financial support behind these endeavors. We have fewer medicines in play for psychiatry, and for infectious threats, for the same reason.
We have been spoiled by a very, very effective infrastructure against infections over the last 50 years. COVID-19, and the relentless, worrisome march of antimicrobial resistance suggests large holes in that armor.
All of the breathtaking innovation in our sector, including the cancer treatments, procedures, and approaches leveraging our immune system are built on an assumption that we already have a strong armamentarium for infectious disease prevention and treatment. The pandemic has exposed a weakness in our defenses, and opened up a new set of great opportunities for biotech to show what it can do. We’ve already made great progress in this most difficult year.
We encourage all of us in the industry to keep doing our part to prevent infectious threats of the future.
Special thanks to Tim Hunt, Aleks Enge of the Novo REPAIR fund, and the Spero Team for their contributions.