Island fast tracks portfolio expansion with acquisition of Galidesivir for ‘high-priority threat’ viruses

• Island to fast-track acquisition of Galidesivir program targeting high-priority threat viruses following positive due diligence
• Galidesivir is a broad-spectrum antiviral with a strong development history and over US$70m in US government R&D funding
• Initial focus on Marburg virus, with potential to pursue FDA animal rule approval and access a priority review voucher

Special Report: Australian antiviral drug development company Island Pharmaceuticals has signed an asset purchase agreement to buy the Galidesivir antiviral program targeting high-priority threat viruses from Nasdaq-listed BioCryst Pharmaceuticals Inc.

After an extensive due diligence period following a letter of intent signed between the two companies, Island Pharmaceuticals (ASX: ILA) said it gained considerable confidence in the Galidesivir antiviral program.

This led to a strategic decision to fast track the acquisition instead of an option agreement with the transaction closing date to occur within the next 30 days.

Galidesivir is a clinical-stage antiviral molecule with a broad spectrum of activity in more than 20 RNA viruses.

These include “high-priority threats” such as Ebola, Marburg, MERS, Zika and Yellow fever – viruses with significant unmet medical needs that may contribute to national security threats.

The molecule has a robust development history, underpinned in recent years by more than US$70m in funding support from the US government.

The funding was used for ongoing clinical development to target Marburg virus disease and, subsequently, Yellow Fever and Ebola virus disease – including drug development, manufacturing, preclinical and clinical trial support.

At the start of its development pathway, the program was designed to target significant threats. It was then expanded to include other emerging infectious diseases, including MERS and Zika for emergency disease outbreaks, later evolving further to pursue other RNA viruses.

FDA’s animal rule could fast track approval  

The Galidesivir program has robust clinical trial data, with completion of phase I studies in healthy volunteers including single ascending dose and multiple ascending dose intramuscular administration studies, as well as intravenous single ascending dose studies.

The data package for Galidesivir also included a successful non-human primate study in Marburg, which will provide a strong foundation for pending clinical trial requirements associated with the US Food and Drug Administration’s (FDA) animal rule.

The FDA’s animal rule allows for approval of drugs in indications based on animal efficacy data, when human trials are unethical or not feasible, provided safety is shown in humans and the disease is well modelled in animals.

Island will now focus on using the FDA’s animal rule to advance the Galidesivir program towards a new drug application (NDA), which has the potential to unlock a Priority Review Voucher, which is likely to be valued at US$100m to US$150m or more.

The transaction was completed for a base purchase price of US$550,000, which includes a US$500,000 acquisition fee and a US$50,000 option fee that gave Island exclusive rights to the Galidesivir program.

Purchase provides Island with second asset

Island’s CEO and managing director Dr David Foster said the company was pleased to acquire Galidesivir.

He said it provided Island a second asset with a longstanding clinical development history and data of early-stage success in multiple RNA viruses,  many of which don’t have approved therapies.

Island’s lead candidate, ISLA-101, is a repurposed antiviral originally developed for other uses, including cancer, but is now being trialled as a potential countermeasure for dengue fever. Island recently reported positive results from its Phase 2 PROTECT study.

“The decision to move directly through to an acquisition followed an in-depth due diligence process, which has given us considerable confidence,” Foster said.

“This has included a comprehensive review of datasets and collaboration with our leading consultants to define a potential path forward for approvals.

Island is now focused on engaging with the US FDA to ascertain potential to leverage the animal rule, which could mean that the company may only be required to undertake one additional successful animal study in Marburg, prior to an NDA.

“If so, a successful animal study could result in approval, which in turn may provide access to a priority review voucher (PRV), Foster said, adding:

“Recent PRVs have been valued at US$100-$150m.”

Chairman Jason Carroll described the acquisition of the Galidesivir antiviral program as exciting and transformational for Island Pharmaceuticals.

“Galidesivir has shown potent and extensive antiviral activity across a wide range of viral diseases including two of the world’s most feared and lethal viral infections, Ebola and Marburg,” he said.

Carroll noted that, of 1,200 categorised biological agents (infectious diseases), the US Centers for Disease Control and Prevention (CDC) classifies Filoviruses (Ebola and Marburg) as one of only six category A bioterrorism threats, those which pose the greatest risk to US national security.

“With a 25-90% mortality rate and no effective treatment for those infected, acquisition of the Galidesivir program provides the company with an exceptional opportunity to deliver an effective treatment in a high priority threat,” he said.

“With two high quality assets, in Galidesivir and ISLA-101, Island is well poised to advance its programs in large, high unmet need market opportunities.”

This article was developed in collaboration with Island Pharmaceuticals, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.