After a tumultuous journey, biotech Acrux (ASX:ACR) will finally be able to sell its toenail fungus treatment in the USA.

The FDA has signed off on Acrux’s generic version of Jublia, a treatment for nail fungus delivered topically (via the skin).

Jublia is a solution already made by Canadian listed pharmaceutical firm Bausch Health (TSX:BHC) but other companies have long sought to produce the active ingredient of it and have contested in courts as to whether Bausch’s patent still stands.

Acrux settled the legal case in 2019 and now has the American regulator’s approval to market its topical solution.

The company says it will now seek a commercial licensee to launch it to the US market.

While Acrux declined to chat when contacted by Stockhead for further comment it says the product will be a lower cost alternative to the original Jublia for American patients.

Jublia’s US sales currently exceed US$217 million per year.

Acrux rose by as much as 30 per cent this morning. The company’s shares have lagged for much of 2021 but today’s rise takes it nearly back to parity with the price it opened the year at.

Acrux (ASX:ACR) share price chart


Other American-approved treatments

Acrux has a long history. It was spun out of Monash University in 1998 and specialises in topically applied drugs, with hope this can prevent any parts of the body not intended to be affected from being impacted.

Acrux is no stranger to getting treatments approved in America.

Back in January, it got approval for its generic testosterone solution and it has a distribution agreement with Dash Pharmaceuticals with provision for the pair to share profits.

The FDA is also currently reviewing a handful of other Abbreviated New Drug Applications (ANDA) from Acrux, one of which is for its version of Dapsone gel which treats common acne.

ANDA applications are one of many types of applications made to the FDA which are specifically for generic drugs based on those already on market.

These are more lenient than other application types (such as s.510(k) approval for medical devices and Investigational New Drug (IND) applications) in that applicant companies only need to demonstrate it performs in a similar manner to the reference drug.

Acrux has a couple of drugs already on market, one of which is an estradiol spray sold in over 35 countries.