Acrux Reports Compelling Results of Market Research on Testosterone MD-Lotion
"After trialling the Acrux product for 4 days, two thirds of patients indicated that they would prefer it to their existing gel treatment."
MELBOURNE, Australia, February 20, 2008-Acrux (ASX:ACR), the Australian based drug delivery company, today announced the results of a patient focused market research study that was conducted over the last 6 months in the USA. The research objective was to confirm and quantify benefits of Testosterone MD-Lotion and provide an objective, independent assessment of patient preference and potential product uptake.
The research involved the recruitment of 81 hypogonadal men who had been previously prescribed either gels or injections to treat their condition. 63 of the subjects used Testosterone MD-Lotion placebo for four consecutive days. The design was both qualitative and quantitative in nature, specifically evaluating in-use handling and application routine compared with existing treatments.
1. After learning about the features of Testosterone MD-Lotion:
* 58% of patients surveyed indicated that they would prefer the Acrux product to their existing gel or injection medication.
* 62% indicated that they would switch to the Acrux solution if their Doctor prescribed it.
* Additionally, two thirds of patients would actively ask their Doctor for information about the Acrux solution, with 65% of gel users and 73% of injection users wanting to know if the Acrux solution is suitable for them right now.
2. After trialling Testosterone MD-Lotion for 4 days:
* Two thirds of patients indicated that they would prefer the Acrux product to their existing gel product.
* Three quarters of patients found that Testosterone MD-Lotion was better than their existing gel treatment in the time it takes to apply and in the time it takes to dry.
* Two thirds of patients found it easier to apply than their existing gel.
* 94% believed that it would reduce the risk of transference.
* 79% of respondents became confident using it within only 2 days of use.
Overall, patients felt that Testosterone MD-Lotion delivers on several highly important and currently unsatisfied needs:
* Provides a convenient application process that can easily be incorporated in the daily grooming routine
* Simplifies the application process and lowers total application time
* Significantly lowers the risk of transference of testosterone to others
* Reduces mess and is easy to clean up
Acrux CEO Richard Treagus commented, "This research has allowed us to validate in a detailed fashion the core benefits of Testosterone MD-Lotion. The results confirm a compelling commercial proposition, addressing an unmet need in a large, growing market. This provides us with a high level of confidence as we complete preparations to move into our pivotal Phase III trial by mid-2008."
European and International media contacts
Justine Lamond and Holly Griffiths
Ph: +44 (0)20 7866 7857
Investor enquiries contact
CEO Richard Treagus / CFO Jon Pilcher
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Business enquiries contact
Hugh Alsop, Business Development
Ph +61 439 080 353
Notes to Editors
About Hypogonadism Hypogonadism is the term used to describe decreased functional activity of the testes with diminished production and action of testosterone. Testosterone deficiency in men (hypogonadism) is associated with a number of symptoms including lethargy, depression, reduced libido and decrease in muscle mass and bone density. It is estimated that over 20% of the US male population over 50 suffer from testosterone deficiency, with the incidence increasing with age. Approximately 10% of hypogonadal men currently receive testosterone replacement therapy.
About the testosterone opportunity The male testosterone deficiency market is large and growing, with global ex-factory sales exceeding USD$600million in 2006, with a growth rate of 14%. Estimates of the prevalence of low testosterone vary from 10% to 39% of men over 50 having testosterone levels below the normal range for healthy men. However, the majority of men with low testosterone remain undiagnosed, with only around 5% to 10% of men receiving treatment. With a high incidence rate and low treatment rates, and only two products in the fastest growing segment (gels) of the market, the male testosterone deficiency market will remain an attractive commercial opportunity.
The last few years has seen a rapid uptake in transdermal gel products, due to the advantages over the more traditional and often invasive methods. Despite the success of these gels, significant issues and drawbacks exist with the current treatments. Large volumes of gel are applied by hand to the upper torso, shoulders or arms, and also require rubbing in to achieve the effective levels. They are considered messy, sticky and may have an unpleasant odour to some patients. One of the biggest drawbacks is the risk of transference to other people through direct skin contact or from residue left on the hands following application.
Testosterone MD-Lotion - A Novel Solution Acrux's novel delivery of testosterone has been designed to overcome the deficiencies of the existing products. Testosterone MD-Lotion is a quick drying and pleasant smelling solution that is applied to the armpits once daily, using a convenient and ergonomic "no-touch" applicator. The armpit is a unique novel application site for transdermal drug delivery and it offers significant advantages to the patient in terms of convenience and vastly reduces the risk of transference from patient to partner.
* 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.
* 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.
* Acrux has one product, Estradiol MDTS(r) (EvaMist(tm) or Ellavie(tm)) to treat menopause symptoms, approved by the US FDA and has the following products in clinical development:
o Testosterone MD-Lotion(r) to treat testosterone deficiency in men
o Testosterone MDTS(r) to treat decreased libido in women
o Nestorone(r) MDTS(r) contraceptive sprays for women
o An undisclosed companion animal health product
o Fentanyl MDTS(r) to treat chronic pain
o Nicotine MDTS(r) for smoking cessation
* Acrux has licensed worldwide rights to its technology for selected contraceptives and for an undisclosed proprietary drug to ORGANON, USA rights for Estradiol MDTS(r) to KV Pharmaceutical and for Testosterone MDTS(r) to VIVUS, and AUS/NZ distribution rights for Estradiol MDTS(r) to Aspen Pharmacare and for Testosterone MDTS(r) and Fentanyl MDTS(r) to CSL Limited. Acrux has also licensed its technology to Eli Lilly and Company for veterinary healthcare products.
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Posted: February 2008