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Lilly, Acrux gain FDA nod for Axiron topical solution CIII.

M2 PHARMA-November 24, 2010-Lilly, Acrux gain FDA nod for Axiron topical solution CIII(C)2010 M2 COMMUNICATIONS

24 November 2010 - US Eli Lilly and Company (NYSE: LLY) and Australian Acrux (ASX: ACR) said yesterday that the US Food and Drug Administration (FDA) has approved Axiron (testosterone) topical solution CIII for replacement therapy in men for certain conditions associated with a deficiency or absence of testosterone.

Safety and efficacy of Axiron in males younger than 18 years of age have not been established, the parties added.

The companies added that Axiron is the first testosterone topical solution approved for application via an armpit (underarm) applicator. Other forms of testosterone replacement therapy include: oral tablets, buccal tablets, subcutaneous pellets, transdermal patches, injections and topical gels applied by the hands.

Upon FDA approval, Lilly received exclusive worldwide rights to commercialise Axiron. In exchange for these rights, Acrux receives an upfront payment of USD50m (EUR37.3m) plus USD3m on the transfer of manufacturing assets.

Acrux is further eligible for USD87m upon the issuance of marketing authorisation by the FDA and up to USD195m in potential commercialisation milestones, as well as royalty payments on future global sales if Axiron is successfully commercialised.

(USD1 = EUR0.746)

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Publication:M2 Pharma
Date:Nov 24, 2010
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