ACRUX LIMITED — Capital/Financing Update 2020

Aug 10, 2020

11 August 2020

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Acrux announces marketing and distribution agreement with Harris Pharmaceutical Inc.

Melbourne, Australia; 11 August 2020: Acrux Limited (ASX:ACR) ( “ Acrux ” or the “ Company ”) is pleased to announce that its 100% owned subsidiary Acrux DDS Pty Ltd has entered into an exclusive sales, marketing and distribution agreement with Harris Pharmaceutical Inc (“ Harris ”) in the United States (“ Agreement ”) for its generic version of EMLA[®] Cream (Lidocaine 2.5% and Prilocaine 2.5%).

As announced on 19 August 2019, the US Food and Drug Administration (FDA) had accepted for review Acrux’s Abbreviated New Drug Application (ANDA) for its generic version of EMLA[®] Cream (Lidocaine 2.5% and Prilocaine 2.5%). Sales generated by EMLA[®] and its generic equivalents with which Acrux’s generic version will compete exceeded USD$22 million in the 12 months to the end of March 31, 2020, based on IQVIA data.

Subject to approval by the FDA, Harris will be responsible for the commercialisation of the product, including the coordination of commercial manufacturing and management of marketing and distribution.

Acrux and Harris will share the gross profits generated from the sales of the product.

The Agreement has a 5-year term from commercialisation.

Acrux CEO and Managing Director, Michael Kotsanis said:

“We are pleased to enter into this agreement with Harris Pharmaceutical which aligns their dermatological experience with the product we have developed. This is the third licensing agreement that we have entered into this year and it too represents another significant step in implementing Acrux’s generics strategy.”

Harris Pharmaceutical President and COO, Robert Maslanski said: “Harris is excited to start a new partnership with Acrux and their team. This product aligns well with our passion for safe and effective dermatological and skin-care products. We look forward to strengthening our partnership with Acrux, going forward.”

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Authorised by the Board of Acrux Limited.

For more information, please contact:

General enquiries

Michael Kotsanis Acrux Limited CEO & Managing Director

P: + 61 3 8379 0100

E: michael.kotsanis@acrux.com.au

About Acrux

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 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.

For further information on Acrux, visit www.acrux.com.au

About Harris Pharmaceutical Inc.

Harris Pharmaceutical, Inc is a diversified team of healthcare veterans, able to provide our customers and partners firsthand experience in all aspects of the dermatology niche – as clinicians, prescribers, drug developers & business professionals.

Harris Pharmaceutical is committed to manufacturing and promoting safe and effective dermatologic products for sales and distribution to customers in all channels of trade. To expand our portfolio, we also pursue a broad spectrum of licensing and partnership opportunities in branded, generic and OTC products.

For further information on Harris Pharmaceutical, visit www.harrispharmaceutical.com