Island Pharmaceuticals Expedites Purchase of Galidesivir RNA Anti-Viral Program

Anti-viral drug development company Island Pharmaceuticals (ASX: ILA) has expedited its US$550,000 acquisition of the galidesivir anti-viral program from US-based BioCryst Pharmaceuticals.

The move followed “considerable confidence” that Island gained in the asset from an extensive due diligence process that included a dataset review and collaboration with consultants to define a pathway for regulatory approvals.

This led to the company’s strategic decision to fast-track the purchase, which it expects to complete within the next four weeks.

Priority Review

A successful new drug application would give Island access to a priority review voucher under a US Food and Drug Administration (FDA) program to incentivise drug development for neglected and rare paediatric diseases.

Vouchers are generally valued in excess of US$150 million and could potentially reduce the company’s future FDA review timelines from 10 months to six months.

The company said further details around future animal studies, clinical trials and associated budgets would be shared following consultation with the FDA.

Anti-Viral Molecule

Galidesivir is a clinical-stage intravenous anti-viral molecule with a broad spectrum of activity in over 20 RNA viruses including Ebola, Marburg, MERS, Zika and Yellow fever, which have unmet medical needs and the potential to be national security threats.

BioCryst has received more than US$70m in US government funding towards ongoing clinical work to target these diseases including drug development, trials and manufacturing.

Phase 1 trials in healthy volunteers have included single and multiple ascending dose intramuscular administration studies, as well as intravenous single ascending dose studies.

Non-Human Primate Study

A non-human primate study of galidesivir was conducted on Marburg disease and the results are expected to provide a foundation for pending clinical trial requirements associated with the FDA’s Animal Rule.

The rule provides a pathway for approving drugs and biological products for serious or life-threatening conditions when human efficacy studies are not ethical or feasible, provided they show safe use on humans and the disease is well-modelled in animals.

Island aims to complete its maiden animal study utilising galidesivir to treat Marburg disease within the next 12 months.

Acquisition Details

Consideration for the acquisition included a US$500,000 upfront fee and a US$50,000 option fee giving Island exclusivity on all rights, title and interest in the galidesivir program.

Additional considerations will include a US$500,000 payment on completion of a Phase 2 clinical trial, $1m on approval of a new drug application, and tiered royalties of between 5% and 10% of net sales.

Island will utilise $4.82m cash at bank plus proceeds from a recent $3.6m share placement to cover costs relating to the acquisition and potential animal trials.