ILA submits for FDA meeting to align on fast tracked “animal rule”

Our biotech Investment Island Pharmaceuticals (ASX: ILA) just recently completed the acquisition of the drug called Galadisivir.

Galidesivir has already been shown to be effective against ~20 viruses in lab tests - many of which sit in the “weaponisable” category (Marburg, Ebola and Zika).

But the one we are most interested in is the Marburg virus - which is what ILA will be targeting as an effective treatment first…

Marburg disease is classified as a Category A bioterrorism threat (the highest level threat) by the US government. (source)

(for Category A bioterrorism threats, governments around the world will generally maintain a stockpile of vaccines or treatments to quickly deploy).

So we would assume if ILA can demonstrate its drug is effective against Marburg, the US government will take an interest in the drug and ILA’s drug could become a potential defence against bioweapons and deadly viruses.

ILA going for fast tracked approvals for it’s new drug

Marburg is a highly dangerous virus that causes severe hemorrhagic fever in humans, with a fatality rate up to 88%.

There is no current vaccine or cure for Marburg.

Every year the US government spends hundreds of millions of dollars stockpiling treatments for bioweapons like anthrax, small pox and other deadly viruses.

Because of how deadly Marburg virus is, ILA could be eligible for a fast-tracked approval under the “animal rule”.

The animal rule is a little known rule that can fast track drugs to market because of how deadly these conditions can be (and the urgency around defending against bioterrorism and bioweapon threats).

Here is how it applies:

• The animal is used for viruses that are are so deadly that running human trials would be unethical or too risky
• The animal rule only requires efficacy to be proven in animals through a Pre-clinical trial where the results can be applied to humans (so using Chimpanzes or other non-human primates)
• Safety will still need to be proven in humans (Galadisivir has a rich safety profile from multiple phase 1 studies)

This meeting with the FDA will give ILA much more clarity as to how the animal rule applies to its newly acquired drug.

IF the FDA approves the use of the animal rule, it could be less than 12-months before ILA brings its Galadisivir drug to market (making it eligible for stockpiling by the US Government).

Also, if ILA gets its drug to market it could be eligible for a Priority Review Voucher (A priority review voucher is a “reward” for biotech companies that develop drugs that the FDA are targeting like Marburg disease).

PRVs are tradeable assets which have fetched up to US$350M (and normally priced at US$150M).

Read our deep dive on Priority Review Vouchers here: More on Priority Review Vouchers

This is a crucial meeting for ILA and we will know more next quarter when the meeting has finalised.

Here are the key catalysts for ILA over the next 6 months:

Key Catalysts for ILA in the next 6-9 months

JUNE: ILA completes the acquisition of Galidisivir ✅

SEP: ILA requests meeting with the FDA ✅

Q4 2025: ILA make a submission to the FDA on whether the drug is eligible for animal approval and priority review voucher (source)

Q4 2025: Commence animal trial for deadly Marburg disease (source)

NEXT: Results of animal trial

NEXT: (Assuming results are good) Submit to FDA for commercial approval and access to Priority Review Voucher.

It is a 6 to 12 month timeline to valuation that all depends on whether the FDA will approve application of the animal rule for ILA’s treatment of Galadisivir.

That FDA meeting (which ILA says should be scheduled for next quarter) is the key risk point for investors, to know whether ILA has a fast track approval.

THEN the next risk point will be whether the animal trials will give ILA enough data to commercialise its product.

But if ILA meets these two hurdles it could have a Priority Review Voucher worth US$150M and in-market drug that is eligible to be sold to the US Government for stockpiling.