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ACRUX LIMITED — Capital/Financing Update 2009
Mar 2, 2009
64293_rns_2009-03-02_08756b95-ab83-4429-bdd0-8ae60d765123.pdf
Capital/Financing Update
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ACRUX (ACR) - ASX ANNOUNCEMENT
3 MARCH 2009
UPDATE ON EVAMIST™ AND KV PHARMACEUTICAL
Acrux today reported that Evamist™ remains unaffected by the business restructuring currently being undertaken by its US licensee for Evamist™, KV Pharmaceutical (NYSE: KV-A). KV’s subsidiary, Ther-Rx, continues to actively promote and distribute Evamist™, which is manufactured for Ther-Rx by a third party.
KV announced the restructuring of its business following a number of product recalls and the suspension of manufacturing and shipment of its products. On 2 March 2009, the US Food and Drug Administration (FDA) and KV Pharmaceutical entered into a consent decree[1] , which stipulates the actions required of KV in order to resume manufacturing (for further details, refer to www.kvpharmaceutical.com).
On 5 February 2009 KV commenced a reduction in its manufacturing and corporate workforce and KV has now initiated a reduction and re-alignment of its sales force to be structured specifically around the promotional needs of Evamist™. The smaller and more focused sales force is dedicated to actively promoting Evamist™ and it will continue to achieve an approximate 90% coverage of the total estrogen replacement therapy prescription market in the US. The Ther-Rx marketing team responsible for the marketing and promotional support of Evamist™ is unaffected by these changes.
KV Pharmaceutical remains positive on the potential for Evamist™ and expects that the weekly growth in prescriptions will continue. Although sales at this stage are below expectations, weekly prescriptions for Evamist have grown consistently since launch, as illustrated by Figure 1 below.
In light of its restructuring, KV has elected not to proceed with investment in the development of additional MDTS[®] spray products, as contemplated by the agreement between Acrux and KV, signed in August 2008. All rights to those products now revert to Acrux and Acrux retains full access to the Evamist™ US registration dossier for commercialisation of Ellavie™ in the rest of the world.
1 If a company has violated the requirements of current good manufacturing practices, the FDA may make a legal agreement with the company to force them to make specific changes. The agreement, the consent decree, is enforced by the federal courts.
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Figure 1: Growth in weekly prescriptions[1] for Evamist™
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----- Start of picture text ----- 3,0002,5002,0001,5001,0005000Weeks since launch1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45Total prescriptions per week----- End of picture text -----
1 Source: IMS data
Contact:
Richard Treagus, CEO & Managing Director
+61 3 8379 0100, or +61 417 520 509
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 has one product, Evamist™ (brand name Ellavie™ outside the USA) to treat menopause symptoms, marketed by its licensee in the USA and has the following products in clinical development:
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Testosterone MD-Lotion[®] to treat testosterone deficiency in men
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Testosterone MDTS[®] to treat decreased libido in women
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Nestorone[®] MDTS[®] contraceptive sprays for women
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An undisclosed companion animal health product
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Nicotine MDTS[®] for smoking cessation
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Acrux has licensed USA rights for Evamist™ to KV Pharmaceutical and for Testosterone MDTS[®] to VIVUS, and AUS/NZ distribution rights for Estradiol MDTS[®] to Aspen Pharmacare and for Testosterone MDTS[®] to CSL Limited. Acrux has also licensed its technology to Eli Lilly and Company for veterinary healthcare products and has an exclusive commercial manufacturing alliance with Orion Corporation.
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