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ACRUX LIMITED — Capital/Financing Update 2007
Jul 31, 2007
64293_rns_2007-07-31_c9e4e0b8-79a6-4f2f-aaa3-f905fffc8907.pdf
Capital/Financing Update
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ACRUX (ASX: ACR) - ASX ANNOUNCEMENT
1 AUGUST 2007
ACRUX IND FOR FENTANYL MDTS[®] ACCEPTED BY FDA
Melbourne 1 August 2007: Acrux (ASX: ACR) today announced that its Investigational New Drug Application (IND) for Fentanyl MDTS[®] has been accepted by the US Food and Drug Administration (FDA). Acrux will now proceed with a Phase 1 clinical trial to test the delivery of Fentanyl across the skin using its patented metereddose transdermal spray system.
“With the FDA’s recent approval of our Estradiol product, the Acrux technology has been further validated and this reinforces our strategy of getting more of our transdermal products to market, as quickly as we can. Fentanyl MDTS[® ] represents a significant commercial opportunity in this regard, and the IND is central to our progress with licensing partners”, commented Acrux CEO Richard Treagus.
Fentanyl is a potent narcotic analgesic commonly used for the treatment of chronic pain. Transdermal fentanyl in the form of patches is currently a popular option for controlling moderate to severe pain associated with cancer, osteoarthiritis, back injury and other conditions. Annual sales of fentanyl products in the US alone comprise approximately US$1.8 billion, with transdermal patches making up two thirds of these sales.
The clinical trial will commence in the second half of 2007, with the aim of demonstrating that Acrux’s MDTS[®] formulation delivers fentanyl into the bloodstream of healthy volunteers in quantities known to be safe and effective in controlling chronic pain.
Contact
Richard Treagus, Acrux CEO +61 417 520 509 [email protected]
About Acrux - www.acrux.com.au
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Acrux is an Australian drug delivery company, developing and commercialising a range of patient-preferred, patented pharmaceutical products for global markets, using its innovative technology to administer drugs through the skin.
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Fast-drying, invisible sprays or liquids provide a delivery platform with low or no skin irritation, superior cosmetic acceptability and simple, accurate and flexible dosing. The technology platform is covered by broad and well-differentiated, issued patents.
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Acrux’s lead product Estradiol MDTS[®] (EvaMist™ in the USA) to treat menopause symptoms has been approved for marketing by the US FDA. Other products in clinical development include:
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Testosterone MDTS[®] to treat decreased libido in women
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Testosterone MD-Lotion[®] to treat testosterone deficiency in men
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Nestorone[®] MDTS[®] contraceptive spray for women
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oFentanyl MDTS[®] to treat chronic pain
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Acrux has licensed worldwide rights to its technology for selected contraceptives and for an undisclosed proprietary drug to ORGANON, USA rights for Estradiol MDTS[®] to KV Pharmaceutical and for Testosterone MDTS[®] to VIVUS, and AUS/NZ distribution rights for Estradiol MDTS[®] to Aspen Pharmacare and for Testosterone MDTS[®] and Fentanyl MDTS[®] to CSL Limited. Acrux has also licensed its technology to Eli Lilly and Company for veterinary healthcare products.
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