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 developing a range of topical and dermatological 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’s expanding portfolio of FDA approved products include Testosterone Topical Solution 30mg/1.5ml, Efinaconazole Solution 10% and Lidocaine and Prilocaine Cream USP, 2.5%/2.5%. Acrux encourages collaboration and is well positioned to discuss partnering and product development.
Facilities and capabilities
With onsite laboratories and a GMP manufacturing facility, Acrux has the capabilities and facilities for early development through to clinical trial manufacture. We hold a TGA clinical trial manufacturing licence.
Acrux employs Quality by Design (QbD) principles in its product development.QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and controls, based on sound science and quality risk management.
Acrux employs highly skilled formulation scientists and analytical chemists to develop topical and transdermal products from inception where the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) are established and defined through to regulatory dossier submission. This pharmaceutical development process includes the following:
- Analytical tools and techniques to reverse engineer and characterise the composition of reference products
- Analytical method development and validation
- Intellectual Property analysis
- Formulation development and small scale manufacture
- In-vitro testing of formulations including In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT) on human skin
- Stability testing of prototype formulations
- Container closure selection and development
- CMC studies and reports for regulatory submissions
- Technical Transfer and project management of contract manufacturers
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.