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ACRUX LIMITED — Capital/Financing Update 2014
Apr 27, 2014
64293_rns_2014-04-27_1e360daa-16cc-424c-aa1f-0fbd0bae62af.pdf
Capital/Financing Update
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ACRUX (ACR) - ASX ANNOUNCEMENT
28 APRIL 2014
AXIRON NET SALES, QUARTER TO 31 MARCH 2014
Acrux (ASX: ACR) today confirmed that Eli Lilly reported Axiron net sales of $39.5 million in its financial results for the quarter ended 31 March 2014. Net sales reported by Lilly for the same quarter to 31 March 2013 were $37.1 million.
On 31 January 2014, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication (DSC), which stated that the FDA is investigating the risk of stroke, heart attack (myocardial infarction) and death in men taking FDA-approved testosterone products. The FDA has not concluded that FDA-approved testosterone treatments increase the risk of stroke, heart attack, or death. The FDA stated that patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their healthcare professionals. The FDA assessment process does not have a defined time period.
The two observational studies that sparked the FDA’s DSC have been criticised for misrepresenting the study results. Three professional medical societies and an international group of over 160 scientists and physicians have petitioned the Journal of the American Medical Association to retract one of the study articles, stating that it is “no longer credible”.
The US testosterone replacement therapy market has been impacted and unless this improves and/or Axiron’s share of market increases, the next milestone may not be met in calendar year 2014. The $50 million milestone remains payable in the first calendar year that the global sales hurdle is met. Axiron has been launched in Canada, Australia, Germany and Brazil, and is approved in Korea and launch is planned for end of June.
Contact
Ross Dobinson, Executive Chairman: 03 9691 5920
About Acrux (ASX: ACR)
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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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The Acrux technology, used in marketed products including Axiron®, Evamist® and Recuvyra™, is based on a fast-drying, small volume, accurately dosed solution, containing penetration enhancers, that when applied topically, deposits drug through the skin for long acting delivery.
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Acrux has three products marketed by licensees in the USA, three products approved in Europe, and further products at earlier stages of development
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