“Getting our foot through the door to any VC... As soon as they hear we're infectious disease, their eyes kind of get big. And then they hear we're antibacterial, their eyes get bigger. And then they hear we're not small molecule, it's like all the alarm bells are ringing.”
In this episode, we sit down with Amanda Burkardt (CEO) and Mayukh Das (COO) of Phiogen Pharmaceuticals, a new entrant in the phage therapy space, to tackle one of the field's most pressing questions: can phage therapy succeed as a business where antibiotics have struggled? Drawing from their experience building a phage company from scratch, and recent discussions with Medicare, they share how they're thinking about drug pricing, reimbursement strategies, and how they’re navigating investor skepticism in antimicrobial development.
Takeaways:
- Starting with clear differentiation is crucial - Phiogen's directed evolution platform allows them to enhance desired phage properties
- The antibiotics market's poor track record has created significant barriers for phage therapy companies seeking investment
- Unforeseen post-approval monitoring costs contributed to Achaogen’s bankruptcy, and must be factored into business planning
- Recent approvals of Live Biologic Products (LBPs) for recurrent C. diff provide a potential pathway for phage therapy pricing (~$10,000 per treatment)
- CMS (Medicare/Medicaid) engagement early in development is critical for establishing reimbursement strategies — they are happy to talk to startups!
- The UK's subscription model for antimicrobials could provide significant value (~$100M over 3 years) for qualifying companies
- Phage companies must demonstrate value beyond one-time treatment to justify higher price points
- Infrastructure development, like standardized susceptibility testing, remains a critical need
- The field needs both fixed cocktails for mainstream use and flexibility for personalized approaches
- Success requires alignment between unmet medical need, pricing strategy, and reimbursement policies
Chapters:
00:00 Introduction to Phiogen and business challenges in phage therapy
08:10 Phiogen's technology platform and differentiation strategy
15:13 Navigating investor skepticism in antimicrobials
27:29 Reimbursement strategies and pricing models
35:04 Learning from Live Biologic Product approvals
43:59 The Pasteur Act and subscription models
47:27 Five and fifteen year outlook for phage therapy
Key Quotes:
“Getting our foot through the door to any VC... As soon as they hear we're infectious disease, their eyes kind of get big. And then they hear we're antibacterial, their eyes get bigger. And then they hear we're not small molecule, it's like all the alarm bells are ringing.”
"As long as people are dying and there are unmet medical needs, it is doable. Getting the business model to support that is going to be more challenging, but it is a real problem. There are people dying and there are people suffering. And so as long as that will be the case, there is a need.”
"By utilizing some high throughput methods, we could actually train phages in a way that hadn't been done before. And we're able to utilize this machine to enhance whatever antibacterial capabilities we want.”
Learn more:
- John Rex’s financial post-mortem on antibiotic company Achaogen: https://amr.solutions/2024/10/14/plazomicin-achaogen-financial-post-mortem-passpasteur/
- UK subscription model for antimicrobials: https://www.england.nhs.uk/publication/antimicrobial-products-subscription-model-guidance-on-commercial-arrangements/
- Pasteur Act information: https://www.congress.gov/bill/118th-congress/senate-bill/1355
- A blog post Amanda wrote last year for Capsid & Tail on Phiogen's approach to phage therapy: https://phage.directory/capsid/phiogen-missing-middle-ground#article: "The Missing Middle Ground of Phage Therapy: Effective Phage Therapeutics that Bridge Economy, Regulation, and Unprecedented Functionality"