Australian antiviral drug development company, Island Pharmaceuticals (ASX:ILA) has completed the acquisition of the galidesivir antiviral program from NASDAQ-listed BioCryst Pharmaceuticals.
Completion of the acquisition follows the execution of an Asset Purchase Agreement in early July. The company conducted final due diligence requirements and has since finalised the transaction.
Galidesivir is a clinical-stage antiviral molecule with a broad spectrum of activity in over 20 RNA viruses, including threats such as Ebola, Marburg, MERS, Zika and Yellow fever.
The program has received over US$70 million in funding support from the US government, which was deployed towards clinical development, targeting Marburg and, subsequently, Yellow Fever and Ebola. Funding was deployed to drug development, manufacturing, preclinical and clinical trial support initiatives.
Island will now focus on fast-tracking regulatory initiatives, which will include potentially leveraging the FDA’s Animal Rule. The FDA’s Animal Rule allows for drug approvals 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’s CEO and Managing Director, Dr David Foster, said, “We are very pleased to have completed this transaction with BioCryst ahead of schedule. Following the asset purchase agreement and a final review of the program, we have gained considerable confidence in galidesivir and the potential to fast-track a New Drug Application and the opportunity for a Priority Review Voucher.
“Work will now focus on collating a relevant data package to submit to the FDA, alongside a meeting request to discuss galidesivir’s eligibility under the Animal Rule. We expect to submit this dossier this quarter, allowing for a potential meeting next quarter, prior to initiating an animal study in Marburg shortly thereafter.”