Acrux’s sixth generic application accepted by FDA for review

Melbourne, Australia – 8 August 2022 Link here : Acrux Limited (ASX:ACR, “Acrux” or the “Company”) is pleased to announce that the US Food and Drug Administration (FDA) has accepted for review
Acrux’s application for a generic version (Abbreviated New Drug Application or ‘ANDA’) of cold
sore treatment, Acyclovir Cream, 5%.

Key Highlights
  • Acrux has submitted an ANDA application to the FDA for Acyclovir Cream, 5%, which has now been accepted for review;
  • Annual addressable market sales for the product exceed US$29 million as measured by IQVIA;  and
  • This announcement marks Acrux’s sixth ANDA accepted for review by the FDA
FDA accepts for review Acrux’s submission

Acrux has submitted an ANDA to seek approval from the FDA to market its generic version of cold
sore treatment Acyclovir Cream, 5%. The FDA has notified Acrux that the application is
sufficiently complete to be accepted for review. The reference listed drug is Zovirax® Cream, 5%
which is marketed by Bausch Health in the United States.
While the FDA administers the review process, the time to ultimate approval is influenced by the
number and nature of questions which may arise as the FDA progresses their review. Once the
FDA has granted approval, Acrux can finalise preparations with its contracted commercial
partner to commence marketing and sales of the product in the United States.

US$29 million addressable market

The total addressable market for the product including existing generics exceeds US$29 million.
There are currently two approved and marketed ANDA products.

The Acrux product portfolio

The Company currently has three products which are actively marketed plus three additional
products which have been accepted for FDA review (including Acyclovir Cream, 5% announced
Beyond that, Acrux is advancing a carefully planned pipeline of products in varying stages of
development either at Acrux or with our contracted manufacturing partners.
Our main priority is to support the development of our pipeline products which are in the later
stages of the development cycle and are therefore closer to commercialisation.
The Company currently has 16 products in various stages of development and commercialisation.

Acrux CEO and Managing Director, Michael Kotsanis said:

“Acrux is extremely pleased to advance another product from its pipeline to FDA regulatory
review. Our key focus is on the continuing transformation of Acrux into a company with a
diversified on-market portfolio and a well-planned pipeline of commercially valued products.
Today’s advancement of Acyclovir Cream, 5% through to the final regulatory stage before
commercialisation is a great example of that strategy in action.
“We have several exciting product development milestones on the short-term horizon including
two new product launches expected in the current financial year along with two further expected
regulatory approvals that will subsequently be commercialised.”

Approved for release by the Acrux Board of Directors.

For more information, please contact:
Michael Kotsanis
Acrux Limited
CEO & Managing Director
P: + 61 3 8379 0100



About Acrux

Acrux is a specialty pharma company with a successful track record of developing and
commercialising a pipeline of topically applied pharmaceutical products. Drawing on 25 years of
experience, Acrux has successfully marketed through licensees a number of products worldwide
with emphasis on the United States. Acrux is formulating and developing a range of topical generic
products by leveraging its highly skilled workforce, on-site laboratories, GMP manufacturing
suite, technical, clinical and commercial experience to bring affordable products to market. Acrux
encourages collaboration and is well positioned to discuss commercial partnering and product
development opportunities.
For further information onAcrux, visit