Acrux and TruPharma launch generic acne treatment in US market

Specialty pharmaceutical company Acrux (ASX: ACR) and its partner TruPharma have launched a generic version of Aczone 5% Gel on the US market to treat acne vulgaris.

Known as Dapsone 5% Gel, the prescription topical medicine was created to manage the common skin condition that involves blockage and inflammation of hair follicles and accompanying sebaceous glands.

In June, Acrux received approval from the US Food and Drug Administration (FDA) for the product, which is believed to have an annual addressable market in the US of more than $26.8 million.

The FDA approval meant Acrux could start producing and marketing the generic version in the US with TruPharma, which became a commercial partner in 2020.

Market sales for Dapsone 5% Gel in the 12-month period ending October exceeded $23m.

Development pipeline

Acrux has been focused on the development and commercialisation of a pipeline of topically-applied pharmacy products for the past 25 years.

The company has 15 products in its portfolio, six of which have been approved by the FDA and two of which are currently generating revenue.

One of the products is expected to be launched on the US market soon and another three are in the process of FDA review.

Acrux has also identified two generic topical projects for startup this year and expects to add two new projects each year moving forward.

The company aims to generate a consistent stream of regulatory submissions, product approvals and market launches with the end goal being a revenue stream from a diversified range of products.

“This portfolio strategy supports our core objective of having a number of products to launch through 2024 and beyond, which is critical to creating a sustainable revenue stream and future expansion of our product pipeline,” the company said.

Half-yearly revenue

Acrux reported a total revenue of $5.77m for the six-month period ending 31 December, representing an increase of $2.53m on the previous corresponding period.

The company said revenue is expected to continue growing as new pipeline products are approved and launched.

These include Prilocaine 2.5% and Lidocaine 2.5% pre-surgical numbing creams, Dapsone 5% Gel and three dossiers under FDA review.