Acrux patent portfolio advances in USA

  • New patent granted in USA for MDTS® drug delivery system
  • Protection against copies of Acrux unique transdermal sprays extended out to 2022
  • Nine patents now granted in USA

Acrux has received notification of the grant of a US patent (number 6,978,945), which provides robust protection for its Metered Dose Transdermal Spray (MDTS®)applicator for delivery of drugs. The applicator is currently used in the three women's health products that Acrux has under clinical development – the contraceptive spray Nestorone® MDTS®, Testosterone MDTS® to treat decreased libido and EvamistTM to treat menopause symptoms. EvamistTM is nearing completion of Phase 3 trials in the USA, with results expected to be available in the second quarter of 2006. The new patent does not expire until 31 July 2022, which is five years later than Acrux's other granted US patents.

Acrux CEO Igor Gonda commented "This new patent provides very broad protection for the familiar part of our products that the patient sees and uses. It means that copies of our unique transdermal spray devices that provide a precise and convenient means of drug delivery are now kept out of the market until 2022 at the earliest".

In addition, Acrux has been granted another US patent (number 6,998,138), expiring in 2017, which provides an additional layer of patent protection for delivery of anti-alopecia (baldness) drugs using Acrux's fast drying skin delivery technology. Alopecia treatments are a part of Acrux's valuable portfolio of dermatology products.

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Contact:
Igor Gonda, CEO & Managing Director
Tel: +61 3 8379 0100

About US patent numbers 6,978,945 and 6,998,138
Patent number 6,978,945 ("Dispensing Device") was filed on 30 November 2001 and has a priority date of 1 December 2000. Claim number 1 describes "A hand-held dispensing device for dispensing and applying a substance to the skin of a host, said device including a hollow body, a capsule mounted within said hollow body and including said substance therein, a nozzle having an outlet passage mounted within said hollow body in communication with said capsule, actuator means operable to cause a metered quantity of said substance to be dispensed from said capsule through said outlet passage of said nozzle, a shroud defining an exit space from said hollow body for receiving said substance emerging from said outlet passage, and closure means including a cap detachably mountable on said shroud to thereby selectively open or close said nozzle and thereby control escape of said substance from said capsule, said outlet passage including an exit end, and said closure means including a closure member that is operative to close said outlet passage by engaging against the surface surrounding said exit end of said outlet passage".

Patent number 6,998,138 ("Topical Delivery of Anti-Alopecia Agents") was filed on 24 July 2001 and has a priority date of 19 February 1996. It provides protection for a drug delivery system that consists of an effective amount of an anti-alopecia agent, a dermal penetration enhancer, which is a safe skin-tolerant ester sunscreen, and a volatile liquid. This is a "continuation in part" patent, related to Acrux's US patent number 6,818,226.

About Acrux
www.acrux.com.au
Acrux is a specialty pharmaceutical company, developing and commercialising a range of patented, patient-preferred healthcare products for global markets, using its innovative technology to administer drugs through the skin.

Acrux's product pipeline includes treatments of hormonal deficiencies, pain, central nervous system disorders and a contraceptive. 20 human clinical trials have been completed with 8 different drugs and the lead product, EvamistTM, is nearing completion of a phase 3 trial in the USA.

Acrux has licensed USA rights for EvamistTM (Estradiol MDTS®) and Testosterone MDTS® to VIVUS and AUS/NZ distribution rights for Testosterone MDTS® and Fentanyl UDTSTM to CSL Limited. Acrux has also licensed its technology to Eli Lilly for veterinary healthcare products.


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