Total votes: 18

Cash reserves: Cash reserves at March 30th 2010 were  $61M.

Key people: Both the board and mangement team consist of people with international pharma/biotech experience fom living abroad for extended periods.

Acrux is a dynamic Australian drug delivery business developing and commercialising a range of pharmaceutical products using innovative, patented technology to administer drugs through the skin.

Fast drying, non-occlusive topical sprays or liquids provide an enhanced transdermal delivery platform with low or no skin irritation,  and simple and flexible dosing. Acrux's product pipeline includes treatment of hormonal deficiencies, central nervous system disorders, contraception and dermatological conditions. The first product is being marketed in the USA by Acrux's licensee following approval by the US Food and Drug Administration (FDA).

Acrux has products in late stage development, follows a lower risk development path and is well funded. The six fundamentals of the business are:

 - Possibly faster, lower risk, lower cost drug product development because products contain proven drugs 
 - Lead product successfully through FDA approval
 - Products in clinical development for a range of therapeutic areas
 - Track record of commercial deals

Company's lead product: AXIRONTM is the company's lead product - a transdermal male testosterone replacement therapy being developed by Acrux for global registration and commercialization.The product is indicated for the treatment of low testosterone in men (hypogonadism), and is applied to the axilla (armpit), in much the same way as deodorants or antiperspirants. The product is applied using a specially designed applicator that ensures the patient avoids contact with the drug formulation, and eliminates the mess and stickiness associated with the use of current testosterone gel products.

The armpit, or axilla, is a discreet and convenient application site, with a greatly reduced risk of transference to partners and the application procedure may be considered part of the normal grooming routine. The fast drying properties, novel application site, and 'no touch' provide some of the market advantages.


US marketing application for AXIRON™ submitted to FDA. Successful AXIRON Phase 3 clinical trial results:
 - 84% of subjects in the normal range after 4 months of treatment, exceeding the US Food and Drug Administration (FDA) requirement of 75%;
 - 76% of subjects in the normal range after only 15 days of treatment;
 - statistically significant improvement from baseline in mood, sexual desire, sexual activity and sexual performance

Acrux has an international patent pending covering the application to the armpit of a number of drugs, including testosterone. Once granted, the patent will provide protection against competing products until at least 2026 in all major markets. AXIRONTM is covered until 2017 by Acrux's granted patents.

Eli Lilly Deal March 2010:

Acrux in an exclusive worldwide licensing agreement with US pharmaceutical giant, Eli Lilly. The terms of the agreement, which is potentially worth up to US$335 million, will give Eli Lilly the rights to market Acrux’s new product,Axiron, an underarm testosterone solution for the treatment of testosterone deficiency in men.

Under the deal, Acrux will receive an up-front payment of US$50 million, plus US$3 million for the manufacturing assets. Acrux will also receive a further US$87 million upon the US Food and Drug Administration’s approval to market Axiron. If successfully commercialised, Acrux will receive up to US$195 million in potential commercialisation milestones, as well as royalty payments on future global sales.

Eli Lilly has a sales, marketing and distribution capability covering 143 countries. 

Competition:

Auxilium (USA listed comapny with gel on market) see article at: www.BioInvest.com.au/news/view/143/