Pharmaceutical company Acrux (ASX: ACR) has secured United Stated Food and Drug Administration approval for its generic testosterone topical solution.
The topical drug is based on Perrigo’s Testosterone Topical solution which has a dose of 30mg per 1.5mL.
Acrux initially submitted an abbreviated new drug application with the FDA in August 2018 to market its generic testosterone product.
Today’s reported FDA approval paves the way for Acrux to manufacture and market the generic drug in the US.
Acrux managing director Michael Kotsanis said the FDA approval was a “major milestone” for the company.
“It is a testament to the hard work and dedication of the product development and regulatory team,” he added.
The testosterone solution is already sold in six countries.
Dash Pharmaceuticals to commercialise testosterone drug in US
In readiness for the approval, Acrux inked an exclusive agreement with Dash Pharmaceuticals in October last year.
Under the deal, Dash is responsible for commercialising the testosterone product in the US, including manufacturing, marketing and distribution.
Profits from the sales will be shared between Dash and Acrux.
“We are excited to partner with Dash to bring this product to market in the current financial year,” Mr Kotsanis said.
Well-funded to pursue growth plans
Late last year, Acrux raised $7.8 million in a “strongly supported” placement and is adding a further $2 million via a share purchase plan.
A new strategic investor BioScience Managers Translation Fund I subscribed for $5 million in the placement giving it a 10% stake in Acrux.
“The demand for the placement is an endorsement of the company’s growth strategy and continued substantial progress on its pipeline of topical generics,” Mr Kotsanis said.
Acrux currently has 13 topical generic pharmaceuticals in development with FDA applications submitted for three.
In addition to the testosterone solution, Acrux has commercialised an oestradiol spray which is sold as Lenzetto in 37 countries and Evamist in the US.