Ardana PLC
26 November 2007
ARDANA ANNOUNCES POSITIVE PRELIMINARY RESULTS FROM A DIFFERENTIATION STUDY OF
ITS TESTOSTERONE CREAM IN MALE HYPOGONADISM
Edinburgh, UK, November 26 2007: Ardana Plc (LSE:ARA), the pharmaceutical
company focused on improving human reproductive health, today announces positive
preliminary results from a differentiation study of its Testosterone Cream for
the treatment of testosterone deficiency in men.
The preliminary results from this study demonstrate a potential differentiation
of Ardana's Testosterone Cream from currently marketed gel preparations, in that
showering as early as one hour after application of the cream does not appear to
have a negative effect on the absorption of testosterone. With existing
testosterone gels the advice given to patients is to delay showering for at
least 2-6 hours after application.
This open label, randomised, cross-over study in 12 male patients with
testosterone deficiency (male hypogonadism) was conducted in a single centre in
the United States under the existing IND. All 12 patients received a single,
low dose (2.25g) of Ardana's Testosterone Cream on four different study days.
In random order the patients had a shower after 1, 2 and 6 hours or not at all.
After this first part of the study all patients applied a single dose of
Testosterone Cream (2.25g) daily for 14 days after which the study experiment
was repeated with a shower two hours after the last application.
The preliminary analysis shows that there is no detrimental effect on the
absorption of testosterone if a patient showers as early as one hour after drug
application when compared to drug application with no subsequent showering.
Commenting on today's announcement, Dr Huw Jones, CEO of Ardana, said: 'We are
very encouraged by these positive results as they indicate a potential advantage
for our Testosterone Cream by allowing patients the convenient option of
showering much sooner after application than is currently recommended for
testosterone gels.'
A pivotal Phase III registration study in men with confirmed hypogonadism in the
United States is currently in the active recruitment phase.
For more information contact:
Ardana Financial Dynamics
Dr Huw Jones (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550 Julia Phillips/Emma Thompson
Tel: +44 (0)20 7831 3113
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 built 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 lead products are summarised below:
• Teverelix LA, in development for three initial indications (prostate
cancer, benign prostatic hyperplasia and endometriosis);
• ARD-0705 a growth hormone secretagogue in Phase III for the diagnosis of
growth hormone deficiency in adults
• Testosterone Cream, a transdermal testosterone delivery system in
development for the treatment of male hypogonadism, in Phase III trials;
• Emselex(R), a once a day treatment for the symptoms of overactive bladder
syndrome, which Ardana has exclusive UK marketing and promotion rights and
is being distributed in collaboration with Novartis UK Limited;
• 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 confirmed
hypogonadism;
• InvicorpTM, an injectable combination drug treatment for erectile
dysfunction, for which Ardana has marketing and manufacturing rights in
Europe and has been launched in Denmark.
In addition, Ardana has a strong portfolio of follow-on products in research.
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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