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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) is a pharmaceutical company dedicated to developing and commercialising specialty and generic topical pharmaceuticals.

Incorporated in 1998 and using in house facilities and capabilities, Acrux has successfully developed and commercialised through licensees a number of pharmaceutical products in the US and Europe using the Patchless PatchTM, a fast-drying and invisible topical application technology. Marketed products include Axiron®, Evamist® and Lenzetto®. More recently, in addition to specialty products, Acrux has identified and initiated development of a range of generic products. Acrux is leveraging its on-site laboratories, GMP   manufacturing suite, clinical and commercial experience to bring more products to market.  Acrux encourages collaboration and is well positioned to discuss partnering and product development.

Products and Technology

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

Acrux’s proprietary technology is covered by broad, well-differentiated, issued patents. They 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, 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

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
2014
  • Evamist licensed to Perrigo in US
2016
  • Lenzetto launched in Europe

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® & Lenzetto®

MDTS-tech

The first product developed by Acrux was the estradiol spray for women, used to treat moderate to severe hot flushes commonly associated with menopause.

Acrux has licenced its estradiol product to Gedeon Richter to commercialise in various territories, including Europe and Eurasia.  Gedeon Richter has received multiple marketing approvals and is expected to launch in 2016. Gedeon Richter have branded Acrux’s estradiol spray, Lenzetto®.

In the United States, Acrux’s estradiol spray is distributed by Perrigo and branded Evamist®. Evamist® has been on sale in the United States since 2009.

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.



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 24 Oct 2017.

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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