Acrux (ASX: ACR) is a pharmaceutical company dedicated to developing and commercialising topical pharmaceuticals. Incorporated in 1998 and using in house facilities and capabilities, Acrux has successfully developed and commercialised through licensees a number of topically applied pharmaceutical products in the US and Europe. Acrux is currently developing of a range of generic products for the US market by leveraging its on-site laboratories, GMP manufacturing suite, clinical and commercial experience to bring affordable 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
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.
First US patent granted
Veterinary licensed to Elanco globally (including Recuvyra®)
Acrux listed on ASX (ACR:ASX)
Evamist® licensed to KV Pharmaceutical in US
Evamist® launched by KV Pharmaceutical
Acrux initiates Axiron® Phase III clinical trial
Acrux submits Axiron® NDA to FDA
Axiron® licensed to Eli Lilly globally
Axiron® launched by Eli Lilly
Recuvyra® launched by Elanco
Estradiol licensed to Gedeon Richter; including for EU
Evamist® licensed to Perrigo in US
Initiated generic programs
Lenzetto® launched in Europe
Active pipeline of 10 generic products