Research Update

RNS Number:7287I
Ardana PLC
11 September 2006

                     ARDANA ANNOUNCES POSITIVE PRELIMINARY

               PHASE II RESULTS FOR ITS NOVEL TESTOSTERONE CREAM



Edinburgh, UK: 11 September 2006:  Ardana plc (LSE:ARA) today announces
preliminary results of its testosterone cream in a Phase II study in hypogonadal
men.  A preliminary analysis of the data confirms that Ardana's testosterone
cream is effective in restoring testosterone levels to the normal range in
hypogonadal men when administered as a single dose of 2.25g or 4.5g on a daily
basis.



The open-label, randomised study involved 16 patients diagnosed with male
hypogonadism i.e. testosterone deficiency.  Over a period of 28 days, two
groups, each of 8 patients, were randomised to receive a daily single
application of Ardana's testosterone cream at a dose of either 2.25g or 4.5g.
Serum testosterone concentrations at steady state were measured over a period of
24 hours at the end of the study, Day 28.



The preliminary analysis shows that 80% of patients on the low dose (2.25g) had
average testosterone concentrations within normal range at Day 28. The average
concentration of testosterone for the low dose on Day 28 was 4.74 ng/ml (normal
range 3-10 ng/ml). This preliminary analysis of an initial dose of 2.25g
indicates that only a small proportion of patients may require an upward dose
titration to adequately replace testosterone to within the normal range.
Furthermore, the data indicates that even before dose titration the low dose
should meet efficacy criteria set by the FDA.



A Phase II long-term dose-titration study in hypogonadal men is currently
ongoing.  Also a Phase I study, conducted in the US under an IND, is ongoing,
investigating the effect of showering on the absorption of testosterone.



A pivotal Phase III registration study in the US is currently being prepared.



Dr Maureen Lindsay, Ardana's CEO said "We are very encouraged by the progress in
the development of Ardana's novel testosterone cream. The preliminary data from
this study meets our expectations for the product and we look forward to moving
into Phase III."



Ardana's testosterone cream consisting of both an oil and water-based phase
together with the active ingredient, testosterone.  Because of its reduced
surface area requirement, Ardana's testosterone cream appears to deliver
testosterone more efficiently than existing gel-based testosterone products and
also has a low alcohol content.  Alternative therapies for male hypogonadism
include injectable formulations of testosterone, oral preparations, transdermal
patches, topical gels and subcutaneous implants.



The male hypogonadism market has experience rapid growth over the last five
years, driven by novel gel formulations which now make up 78% of the US market
by value.  The US market size is estimated to be $470 million (IMS MAT Feb 06).



For more information contact:
Ardana                                     Financial Dynamics
Maureen Lindsay                            (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550                 Julia Phillips/John Gilbert
                                           Tel: [phone]





About Ardana

Ardana plc is a pharmaceutical company focused on the discovery, development and
marketing of innovative products to improve human reproductive health, a $25.5
billion market.



Since its foundation, Ardana has maintained a broad and balanced portfolio to
manage risk and actively pursues product and technology in-licensing and
outlicensing to maintain a robust pipeline.



Ardana's four lead products are summarised below:



  * StriantTM SR, a testosterone replacement therapy that has been launched by
    Ardana through its own sales force in the UK and through marketing partners
    in certain European countries, as a treatment for men with hypogonadism;
  * Teverelix LA, in development for three initial indications (prostate
    cancer, BPH and endometriosis);
  * Testosterone Cream, a trans dermal testosterone delivery system in
    development for the treatment of male hypogonadism, in Phase II trials;
  * Invicorp, an injectable combination drug treatment for erectile
    dysfunction, for which Ardana has marketing and manufacturing rights in
    Europe.



In addition, Ardana has a strong portfolio of follow-on products in development.

Ardana is listed on the Main Market of the London Stock Exchange.



For further information please see www.ardana.co.uk






                      This information is provided by RNS
            The company news service from the London Stock Exchange
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