The company plans to submit a drug dossier to the FDA this quarter. Pic: Getty Images.
- ILA completes antiviral drug acquisition ahead of schedule
- Drug has a broad spectrum across viruses
- FDA submissions and a meeting request anticipated this quarter
Special Report: Island Pharmaceuticals has finalised its acquisition of the Galidesivir antiviral program from BioCryst Pharmaceuticals after completing due diligence ahead of schedule.
Galidesivir is a clinical-stage antiviral molecule with a broad spectrum of activity in more than 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika and Yellow fever.
Notably, these are all viruses with significant unmet medical needs that may contribute to national security threats.
Island Pharmaceuticals (ASX:ILA) is confident in the drug’s potential, thanks to its robust development history and more than US$70m R&D spend from the US government to date.
The company is now focused on fast tracking regulatory initiatives, including potentially leveraging the FDA’s Animal Rule, which 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.
Drug dossier planned to FDA this quarter
Island intends to submit documentation on the Galidesivir program to the FDA in the short term and seek a meeting with the regulator, possibly during the December quarter.
Pending positive feedback, this may allow for the commencement of an animal study before the end of the year.
“We are very pleased to have completed this transaction with BioCryst ahead of schedule,” CEO and managing director Dr David Foster said.
“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.”
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.