Acrux seeks FDA approval of generic acne treatment to disrupt $30 million market

Mask-ne, iso skin, whatever the beauty blogs have dubbed it, acne sucks. 

Yes, one of the many irritating side effects of this pesky pandemic is the resurgence of my teenage skin. Regular mask wearing and heightened stress has contributed to my new spotty appearance. 

Sadly, my bathroom wouldn’t make for a very good “shelfie” these days with the intensely marketed anti-acne products in pretty packaging being forgone for white bottles with a prescription sticker. 

With the global acne medication market set to hit USD $13.35 billion by 2027, companies like Acrux (ASX: ACR) are seeking to snag their share. 

Specialising in topical medications, the Company has submitted an Abbreviated New Drug Application with the US Food and Drug Administration (FDA) for the generic version of acne treatment, Dapsone Gel 5%. 

The submission has been accepted for review by the FDA. Once approved they will be able to commence marketing and distribution of their generic in the US, potentially grabbing a market share of the USD $30 million addressable market which is currently only served by one approved and marketed product.  

The product functions to treat acne by helping decrease the number and severity of acne pimples and accelerating the healing of skin. 

The FDA submission marks Acrux’s fifth generic Abbreviated New Drug Application that has been accepted for review. 

Acrux CEO and Managing Director, Michael Kotsanis said: “Our team is pleased to achieve another milestone for our product development pipeline with this dossier submission. We will now work with the FDA to address any queries they may have on our dossier as we work towards approval and launch. This is another example of Acruxa developing products which, on approval and launch, will provide affordable alternatives to patients.” 

The Company has an active pipeline of 15 generic products, 3 of which are fully approved and on market. The focus on topical treatments involved greater complexity than oral generic drug development; however, the space offers limited generic competition given this complexity and the niche market. 

For the Year ended 30 June 2021, Acrux reported $1.37 million in revenue with a net loss after tax of $12.63 million primarily attributed to their pipeline of 15 products under development.