Research Update
Ardana PLC
12 April 2006
ARDANA ANNOUNCES POSITIVE PHASE II RESULTS FOR TESTOSTERONE CREAM
-- Company announces Phase II results--
Edinburgh, UK: 12 April 2006: Ardana plc (LSE:ARA) today announces positive
results of its testosterone cream in a Phase II study in Hypogonadal Men. This
Phase II dose-finding study provided clear evidence of the effectiveness of
Ardana's bi-gel technology for the transdermal delivery of testosterone.
The double-blind, randomised, placebo-controlled study involved 42 patients
diagnosed with confirmed male hypogonadism, i.e. testosterone deficiency. Three
groups, each of 14 patients, received in random order a single application of
the testosterone cream at a dose of 1.5g, 2.25g or 3.0g, or a placebo cream.
Both placebo and active cream were applied to one upper arm only.
The data show that maximal serum concentration was achieved between 10 and 12
hours after the application. For the three doses, 1.5, 2.25 and 3.0g, the
average concentrations of testosterone over 24 hours were 2.06, 2.13 and 2.63 ng
/ml and the maximal concentrations were 3.35, 3.53 and 5.66 ng/ml respectively.
This observed data is consistent with data reported previously. Pharmacokinetic
modelling of the data from this study predicts that testosterone can be fully
restored in hypogonadal men, to within normal range with one of the following
two doses; 1.5g or 2.25g, or combinations thereof; when administered on a daily
basis (i.e. at steady state).
Ardana has also initiated a further one month Phase II study in hypogonadal men.
In this study, steady state conditions of testosterone and longer-term
tolerability are being evaluated. A pivotal Phase III registration study is
expected to be completed by end 2006.
Ardana's testosterone cream, which is in Phase II of clinical development in
Europe, is a stable 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.
Dr. Maureen Lindsay, Ardana's CEO, said 'We are very encouraged by the data and
development progress of this novel testosterone cream, which we see as
complementary to StriantTMSR, our buccal testosterone tablet already on the
market for men with hypogonadism.'
The male hypogonadism market has experienced rapid growth over the last five
years, driven by novel gel formulations which now make up 76% of the market by
value. The current US market size is estimated to be $473 million (IMS MAT Nov
05).
For more information contact:
Ardana plc Financial Dynamics
Maureen Lindsay (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550 David Yates
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 $23.8
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
out-licensing to maintain a robust pipeline.
Ardana's four lead products are summarised below:
• StriantTM SR, a testosterone replacement therapy for which Ardana has
marketing rights in Europe, has already been launched by Ardana through its
own sales force in the UK as a treatment for men with confirmed hypogonadism
• Teverelix LA, in development for three initial indications (prostate
cancer in Phase II, benign prostatic hyperplasia in Phase II and
endometriosis in Phase I)
• Testosterone Cream, a transdermal testosterone delivery system in Phase II
for the treatment of male hypogonadism
• Invicorp(R), an injectable combination drug treatment for erectile
dysfunction, already approved in Denmark and for which Ardana has marketing
and manufacturing rights in Europe. Launch is expected in H2 2006
In addition, Ardana has a strong portfolio of follow-on products in development.
Ardana has been listed on the main board of the London Stock Exchange since
March 2005 (ARA.L).
For further information please see www.ardana.co.uk
-- ENDS --
This information is provided by RNS
The company news service from the London Stock Exchange