About Acrux

About Acrux

Acrux (ASX: ACR) is a pharmaceutical company dedicated to developing and commercialising specialty and generic topical pharmaceuticals.

Incorporated in 1998 and using in house facilities and capabilities, Acrux has successfully developed and commercialised through licensees a number of pharmaceutical products in the US and Europe using the Patchless PatchTM, a fast-drying and invisible topical application technology. Marketed products include Axiron®, Evamist® and Lenzetto®. More recently, in addition to specialty products, Acrux has identified and initiated development of a range of generic products. Acrux is leveraging its on-site laboratories, GMP   manufacturing suite, clinical and commercial experience to bring more products to market.  Acrux encourages collaboration and is well positioned to discuss partnering and product development.

Products and technology

Currently, we have three pharmaceutical products approved and marketed and are investing in research to develop further products to meet patients’ needs.  Learn more about our commercialised products.

Acrux’s proprietary technology is covered by broad, well-differentiated, issued patents. We continue to develop this technology, expanding the breadth of molecules which can be administered topically.

Facilities and capabilities

With onsite laboratories and a GMP manufacturing facility, we can oversee our products from early development through to clinical trials. We hold a TGA licence for the manufacture of transdermal and transmucosal products for clinical trials.

Our development processes include, but are not limited to:

  • Analytical method development and validation
  • Container closure selection
  • Applicator or device development
  • Extractables and leachables testing
  • Stability testing
  • Manufacturing scale-up and technical transfer to commercial-scale facilities
  • Performing  CMC activities, studies and reports for regulatory submissions

Shareholders

Acrux Limited is a listed entity on the ASX and is a Pooled Development Fund, registered under the Pooled Development Fund Act 1992.

Under the Pooled Development Fund Act 1992, shareholders are entitled to concessionary tax treatment in Australia for income and capital gains derived in connection with their shareholding. Gains realised on the disposal of shares will not be included in an investor’s assessable income in Australia. An investor will not be entitled to any deduction or capital loss on the sale of shares. Unfranked dividends received by an Australian resident will be exempt from tax. Franked dividends will also be exempt from tax unless the shareholder elects to be taxed.

An Australian corporate tax entity may credit its franking account (with franking credits attaching to a franked dividend), regardless of whether it has elected to treat the dividend as exempt or assessable income. Dividends paid to non-residents will not be subject to withholding tax. A shareholder or prospective shareholder should obtain their own tax advice rather than relying on this summary.

ACRUX TIMELINE

1998

Acrux incorporated

2001

First US patent granted

2003

Veterinary licensed to Elanco globally (including Recuvyra®)

2004

Acrux listed on ASX (ACR:ASX)

2007

Evamist® licensed to KV Pharmaceutical in US

2008

Evamist® launched by KV Pharmaceutical

Acrux initiates Axiron® Phase III clinical trial

2010

Acrux submits Axiron® NDA to FDA

Axiron® licensed to Eli Lilly globally

2011

Axiron® launched by Eli Lilly

2013

Recuvyra® launched by Elanco

Estradiol licensed to Gedeon Richter; including for EU

2014

Evamist® licensed to Perrigo in US

2016

Lenzetto® launched in Europe