Quickfire FDA approval for Acrux’s testosterone sends share price soaring

Aussie pharmaceuticals company Acrux (ASX: ACR) is quickly making inroads through the lucrative American healthcare system with regulatory approval granted for their generic equivalent of a common testosterone topical solution which generates more than $25 million annually.

Approval was granted from the Food and Drug administration for Acrux’s gel following their submission in August 2018 where Acrux’s strategy to only manufacture generic products saved the company a significant amount of time and money by not having to undertake extensive clinical trials to collect data.

“FDA approval is a major milestone for Acrux and its generics strategy. It is a testament to the hard work and dedication of the product development and regulatory team,” said Acrux CEO, Michael Kotsanis.

With the regulatory approval, Acrux can commence commercialisation of their product immediately, with their American distribution partner Dash Pharmaceuticals to oversee sales and marketing under a profit share agreement.

Being a generic product which has already been on the market since Perrigio was granted FDA approval for their product in March 2017, Acrux will seek out a share of the market where IVQIA data showed more than USD $25 million was spent on the product in the 12 months ending 30 September 2020.

Across their wider range of generic products, Acrux has 13 topical generic pharmaceuticals in their development pipeline, with 2 of these products submitted to the FDA to go with their newly approved testosterone gel.

ACR shares surged following news of today’s FDA approval, opening at $0.275, a rise of 54.5% on their previous $0.165 close.

Acrux values the global market for generic topical solutions at $18 billion annually where their products are already sold in 38 countries.