ILA appoints US exec who has secured US$490m+ in US Government biodefence funding including stockpiling contracts.

Our Biotech Pick of the Year Island Pharmaceuticals (ASX: ILA) just made another major US biodefence hire.

ILA appointed Mr Raymond Taylor - ex-BioCryst Pharmaceuticals who originally developed ILA’s Galidesivir drug.

This is ILA’s second senior US biodefence appointment recently, Mark Herzog joined as Senior Global Health Security Advisor last week.

The standout line in Taylor’s CV for us was his US Government funding track record.

He was part of the team that secured more than US$490M in US biodefence funding, including US$125M in procurement contracts supporting the US Strategic National Stockpile (SNS).

Here were the other organisations he has worked with:

• CDC: Centers for Disease Control and Prevention (The frontline public health protection agency for the United States.)
• NIAID: National Institute of Allergy and Infectious Diseases (A major branch of the National Institutes of Health (NIH))
• BARDA: Biomedical Advanced Research and Development Authority (An agency under the Administration for Strategic Preparedness and Response (ASPR) created in 2006.)

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Before BioCryst he also held senior roles at EMD Pharmaceuticals (Merck KGaA, the world’s oldest operating chemical and pharmaceutical company, based in Germany), AstraZeneca and Accenture.

So ILA just hired someone with US Government biodefence contracting experience at quite some scale.

We think the hire comes at the right time for ILA because:

1. ILA’s about to kick off animal trials for its Marburg disease, and
2. As the ebola outbreak seems to be getting worse around the world…

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ILA’s drug Galidesivir has previous studies showing:

• 94% overall survival rate in Marburg-infected primates compared to 0% survival in placebo group (100% when administered 24-48 hours)
• 100% survival rate in Ebola-infected primates – versus 0% in placebo group

We highly recommend reading the Q&A section in the back of today’s announcement - its a really good summary of why today’s announcement matters for ILA.

More on the Ebola connection

We wrote about the Ebola connection to ILA in Monday on detail:

ILA: World Health Organisation declares “Health Emergency of International Concern” as harder to detect strain of Ebola with no approved vaccine kills 80, spreads to major city.

Right now there is no approved vaccine or treatment for this Ebola strain.

During the largest ever Ebola outbreak in history (2014 to 2016, 11,300 deaths) a US biotech company worked on an Ebola treatment with US government funding, developing it in US military controlled laboratories.

Animal trials were run and the drug showed it was 100% effective against Ebola inside the first 48 hours.

(the drug also has positive Phase 1 clinical human safety data - so its been tested in humans too)

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Then US government funding expired, that company pivoted to rare diseases.. and it sold this drug.

The drug is called Galidesivir - ILA acquired it from $3.2BN Biocryst Pharmaceuticals last year.

BioCryst together with the US Department of Defense and BARDA (Biomedical Advanced Research and Development Authority) spent over US$70M developing the drug over 10+ years.

Here are the results from that primate study again:

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What's next for ILA?

🔄 Galidesivir Animal Rule approval pathway

Here are the two next major milestones for ILA’s Galidesivir drug:

• Stage 1 - Optimisation study - Working out the optimal dose and the best time to administer it.
• Stage 2 - Pivotal confirmatory study - The big one - this will determine how effective Galidesivir really is. Fingers crossed it improves on that 94% survival rate.

Here are the milestones we are tracking for the trials:

Stage 1 - Optimisation study:

• ✅FDA confirmed Animal Rule eligibility
• ✅FDA confirmed staged approach for approvals
• ✅CRADA (Cooperative Research and Development Agreement) signed with USAMRIID (US Army’s premier infectious disease research institute) and Geneva Foundation (highly influential non-profit that manages nearly US$383M in military medical research funding)
• 🔄Optimisation study (commencing soon)

Stage 2 - Pivotal study:

• 🔲 Pivotal study design completed
• 🔲 Pivotal study commences
• 🔲 Pivotal study results
• 🔲 FDA submission (NDA)

IF the pivotal study results are positive, ILA could then pursue:

🔲 FDA approval of Galidesivir for Marburg
🔲 Priority Review Voucher (~US$200M based on recent sales)
🔲 US Government Strategic National Stockpile contract (potentially worth hundreds of millions in revenue)

Here is an indicative timeline on when to expect all of the above from ILA’s recent presentation:

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