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Acrux Limited (ACR)
is a publicly listed company on the Australian Securities Exchange (ASX).


{{businessSummary}}

General Overview

About Acrux

Acrux (ASX: ACR) develops and commercialises pharmaceutical products for global markets. They use innovative technology to administer medicines transdermally (through the skin) and have a successful history of partnering with global pharmaceutical companies.

Products and Technology

Currently, Acrux have three pharmaceutical products approved and marketed and are investing in research to develop further products to meet patients’ needs. 

Acrux’s unique technology was invented by scientists at Monash University and is covered by broad, well-differentiated, issued patents. Since then, we have further developed this technology, expanding the breadth of molecules which can be administered – with their associated applicators allowing for simple, accurate and flexible dosing of their pharmaceutical products.

Facilities and Capabilities

With onsite laboratories and a GMP manufacturing facility, Acrux can oversee their products from early development through to clinical trials. They also hold a TGA licence for the manufacture of transdermal products for Phase II and III clinical trials.

Acrux's 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
Successes

Acrux's work focuses on developing drugs to meet a defined Target Patient Product Profile. This ensures that Acrux products are preferred by patients over existing therapies.

To date, they have received two 2010 Governor of Victoria Export Awards, including the Victorian Export Award for Innovation Excellence. In March 2010, Acrux signed the largest single product Iicensing deal in the history of Australian biotechnology for Axiron®, a treatment for hypogonadism (testosterone deficiency in men). Learn more about Axiron.

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 LillyV
2013
  • Recuvyra® launched by Elanco
  • Estradiol licensed to Gedeon Richter; including for EU
2013
  • Recuvyra® launched by Elanco
  • Estradiol licensed to Gedeon Richter; including for EU

Products

Axiron

Axiron 2Axiron® (testosterone) topical solution CIII is the first testosterone topical solution approved for application via an armpit (underarm) applicator. Axiron® is used to treat adult males who have low or no testosterone. Other forms of testosterone replacement therapy include: oral tablets, buccal tablets, subcutaneous pellets, transdermal patches, injections and topical gels applied by the hands.

Axiron® has been licensed exclusively to Eli Lilly and has been launched in the United States of America, Canada, Australia, Germany, Brazil and South Korea.

Testosterone Deficiency

Testosterone deficiency is a clinical condition in which the testicles, hypothalamus or pituitary gland is affected by disease or damage that results in decreased testosterone production. Testosterone deficiency also may be known as hypogonadism or low testosterone.

Ellavie® & Evamist®

MDTS-techThe first product developed by Acrux was the estradiol spray for women, used to treat moderate to severe hot flushes commonly associated with menopause. Branded Evamist®, the spray is distributed in the USA by Perrigo.

Acrux has licenced the estradiol product to Gedeon Richter to commercialise in various territories, including Europe and Eurasia. Marketing applications are under regulatory review. Marketing applications are also under review in South Africa (through their licensing partner, Aspen South Africa) and South Korea (through their licensing partner Alvogen Korea).

About the Estradiol product

This estradiol product is different to other transdermal systems. The spray is applied clear, generally dries in less than two minutes and has a low incidence of reported skin irritation.

Acrux’s estradiol transdermal spray is not formulated as a membrane controlled reservoir or solid matrix system requiring a backing, adhesive and release liner. Accordingly, the product has several potential advantages over currently approved transdermal estrogen products.

Clinical studies have shown that estradiol delivered in the Ellavie formulation is absorbed through the skin and provides efficacious serum concentrations for the treatment of  vasomotor symptoms in postmenopausal women. The fast-drying spray delivers a low dose of estradiol, resulting in therapeutic blood levels similar to the exposure range for other approved estrogen products.

Recuvyra®

recuvyraRecuvyra® is a fentanyl solution used for post-operative pain relief in dogs. The product is marketed by Elanco, Eli Lilly and Corporation Animal Health Division – and has been approved in the USA and Europe. Elanco Animal Health has an exclusive worldwide licence to develop and commercialize Acrux’s technology to deliver medicines through the skin of companion animals.



Contact Info

Acrux Limited

103-113 Stanley Street
West Melbourne, VIC
AU Australia, 3003

Phone: +61 3 8379 0100
Fax: +61 3 8379 0101
Email: bd@acrux.com.au
Website: http://www.acrux.com.au

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Acrux Limited Google Map
Acrux Limited Google Map

Share Registry

Link Market Services Limited - Click here to view share registry profile

Phone: +61 2 8280 7100
Fax: N/A
Email: info@linkmarketservices.com.au
Website: http://www.linkmarketservices.com.au/

Level 12
680 George Street
Sydney, NSW
AU Australia, 2000


Important Information

The General Overview, Services, Products and Projects information for this profile was last edited on 20 Jul 2015.

All Financial Data is provided "as is" for informational purposes only, not intended for trading purposes or advice. Neither Share Prices nor any independent data provider is liable for any informational errors, omissions or other defects, incompleteness, or delays, or for any actions taken in reliance on Financial Data.

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