Acrux’s generic cold sore cream accepted for review by FDA, set to disrupt Zovirax

With today’s insane cost of living, if there’s a cheaper option to something you best believe I’m picking it. I am all about home brand cheese and ibuprofen sans shiny box. 

Pharmaceutical company Acrux (ASX: ACR) gets it, having lodged an application with the US Food and Drug Administration (FDA) for review of their generic version of Acyclovir Cream, a cold sore treatment. 

Once approved, the Company is hopeful that the cream will compete with Zovirax Cream as an alternative. Zovirax is currently marketed by Bausch Health in the United States. 

Acrux has determined the addressable market for their new generic to be in excess of USD $29 million, but not everyone is smearing their cold sores with Zovirax. There are currently two approved and marketed similar generic products that will be in direct competition with Acrux’s cream. 

“Acrux is extremely pleased to advance another product from its pipeline to FDA regulatory review,” said CEO and Managing Director Michael Kotsanis. 

“Our key focus is on the continuing transformation of Acrux into a company with a diversified on-market portfolio and a well-planned pipeline of commercially valued products. Today’s advancement of Acyclovir Cream, 5% through to the final regulatory stage before commercialisation is a great example of that strategy in action. 

As a method of cash saving, Acrux isn’t developing new drugs, but rather is focussed on commercialising generic topical drugs. When applying to regulators for approval, the Company only needs to submit an Abbreviated New Drug Application. Acrux currently has three products actively marketed and a further three that are under FDA review. 

Abbreviated New Drug Applications do not need to include preclinical and clinical data to prove safety and efficacy like new drugs do. Acrux’s application for Acyclovir Cream has been accepted by the FDA and will be subject to their stringent review process. Consequently the Company has begun preparations with its contracted commercial partner to plan marketing and sales of the product within the US. 

Kotsansis said: “We have several exciting product development milestones on the short-term horizon including two new product launches expected in the current financial year along with two further expected regulatory approvals that will subsequently be commercialised.”

For the half year ended 31 December 2021, the Company reported an 80% increase in revenue of over $2 million and rounded out the half with $10.6 million in the bank.