ILA granted a US patent for its Marburg disease drug
Our 2025 biotech Pick Of The Year Island Pharmaceuticals (ASX: ILA) has just been granted a patent for its Galidesivir drug out to October 2031.
A patent In simple terms gives ILA a monopoly to sell its drug/treatment for the defined period of time.
ILA’s patent covers treatments of filoviridae viral infections with Galidesivir.
The filoviridae virus family includes Ebola and ILA’s current main area of focus Marburg disease.
Filoviridae viruses are classified as biological select agents or toxins (BSAT) by the US government - which means any treatments developed treating them could benefit from government stockpiling contracts for bioterrorism protection.
ILA’s focus is on developing an antiviral drug (Galidesivir) to treat Marburg disease.
Marburg virus is classified as a Category A bioterrorism threat (the highest level threat) by the US government (source).
At the moment Marburg is the only Category A biothreat with no current vaccine or FDA approved treatment…
ILA recently got approved for a fast tracking avenue utilising the “Animal Rule” and a valuable Priority Review Voucher.
The animal rule process allows ILA to skip a 15+ year, expensive process of human phase 2 & 3 clinical trials and instead go for FDA approvals based on animal data alone.
(Source)
Basically the animal rule process is FDA’s pathway for approving drugs for diseases where human trials wouldn't be ethical to run.
What is the Animal Rule?
ILA is going for approvals on the drug via a fast tracked “Animal Rule” approvals pathway - which is basically where biotech’s can seek FDA approvals for really deadly diseases on animal trials alone.
(Cutting out the 10-15 years of human trials needed for most drugs).
Read more about the animal rule here: How can ILA fast track approvals through the “Animal Rule”?
We are Invested in ILA to see it go through the animal rule process - get its drug FDA approved (fingers crossed).
Approvals for ILA (potentially inside the next 12-18 months) could unlock:
- A Priority Review Voucher (PRV) that comes in if ILA’s Galidesivir is FDA approved - these can be worth on average ~US$150M.
- US Government national stockpiling deals - these can be worth anything between US$100M to US$1.2BN ANNUALLY
We covered all of this in our most recent note here: ILA: Our Biotech Pick of the Year
What’s next for ILA
Mid November: ILA confirmed Animal Rule eligibility for its Marburg drug ✅
Mid December: ILA signs agreement with Texas Biomedical Research Institute (capable of running the trials/studies for ILA) ✅
NEXT: FDA provides feedback on ILA’s animal trial design and ILA confirms it will be using the animal rule FDA approval process for its Margurg disease drug.
NEXT: Commence animal trial for Marburg disease.
After that point we will be tracking the following milestones for the study:
- ✅ Deal signed with clinical trial research facility. (source)
- 🔲 Clinical trial design completed
- 🔲 Clinical trial starts
- 🔲 Clinical trial completed
- 🔲 Clinical trial results
NEXT: (Assuming results are good) Submit to FDA for commercial approval and access to Priority Review Voucher
