Australian antiviral drug development company, Island Pharmaceuticals (ASX:ILA), has signed an agreement to acquire the galidesivir antiviral program from US-based BioCryst Pharmaceuticals.
The acquisition follows the signing of a letter of intent between the companies, which was announced in September last year, and a due diligence period. Island said that, as a result of its due diligence, it had decided to fast-track the acquisition of galidesivir.
Galidesivir is a clinical-stage antiviral molecule with a broad spectrum of activity in over 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika and Yellow fever – viruses with significant unmet medical needs and that may contribute to national security threats. It is a nucleoside analog that mimics adenosine triphosphate (ATP) and inhibits viral RNA synthesis, allowing broad activity against many RNA viruses.
It has robust clinical trial data, including the completion of Phase 1 studies in healthy volunteers, which encompassed single ascending dose and multiple ascending dose intramuscular administration studies, as well as intravenous single ascending dose studies.
Island’s CEO and managing director, Dr David Foster, said, “We are very pleased to acquire Galidesivir. The acquisition provides Island with a second asset, which has a longstanding clinical development history and data of early-stage success in multiple RNA viruses – many of which do not have approved therapies.”
“The decision to move directly through to an acquisition followed an in-depth due diligence process, which has given us considerable confidence. This has included a comprehensive review of datasets and collaboration with our leading consultants to define a potential path forward for approvals,” said Dr Foster.
“The Company is now focused on engaging with the US FDA to ascertain the 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 a New Drug Application.”
“If so, a successful animal study could result in approval, which in turn may provide access to a Priority Review Voucher. Recent PRVs have been valued at US$100- $150m,” said Dr Foster.
Chairman Jason Carroll added, “The acquisition of the Galidesivir antiviral program is both exciting and truly 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. Of 1,200 categorised biological agents (infectious diseases), the US CDC classifies Filoviruses (Ebola & Marburg) as one of only six Category A bioterrorism threats – those threats which pose the greatest risk to US National Security.
"With a 25 to 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. 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.”