Research Update
Ardana PLC
19 December 2006
ARDANA ANNOUNCES PRELIMINARY RESULTS IN A PHASE II STUDY OF TEVERELIX LA IN
BENIGN PROSTATIC HYPERPLASIA
Edinburgh, UK, 19 December 2006; Ardana plc (LSE:ARA) today announces
preliminary results from a Phase II study of its lead development compound, the
GnRH antagonist Teverelix Long Acting (LA) in benign prostatic hyperplasia
(BPH).
Teverelix LA, administered as a single subcutaneous injection, demonstrated
symptomatic improvement from as early as week two and the duration of the effect
appears to be in the order of 8 weeks based upon a preliminary analysis of the
relevant clinical endpoint, the International Prostate Symptom Score (IPSS).
The study was a Phase II, randomised, double-blind, placebo-controlled study
investigating the effects and safety of two different doses of Teverelix LA when
administered as a single subcutaneous injection to treatment naive patients with
BPH (total number of patients was 84). The findings in this study confirm the
effects of Teverelix LA on symptoms of BPH as previously reported. Further
analysis of data is ongoing.
In previous clinical studies, Teverelix LA has been shown to decrease
testosterone and subsequently dihydrotestosterone (DHT) in a dose-dependent
manner ie reducing testosterone levels to the low end of the normal range, which
should help to avoid a chemical castration and its related symptoms. In an
earlier Phase II study in patients with BPH, Teverelix LA demonstrated a
statistically significant improvement in symptoms of BPH as measured by the
IPSS.
BPH is a common benign disease occurring primarily in men over the age of 50,
and increases in prevalence with age. BPH is characterised by an enlargement of
the prostate gland, which results in urinary flow problems such as hesitancy,
weak or interrupted stream, urgency and more frequent urination, especially at
night.
The growth of prostatic tissue is driven by male sex hormones (known as
androgens), primarily testosterone and its more potent metabolite DHT. Reducing
levels of these hormones can reduce the size and growth of the prostate.
Current treatment options for patients with BPH include watchful waiting,
surgical or endoscopic treatment or medical treatment with 5-alpha reductase
inhibitors or alpha blockers. The BPH pharmaceutical market is estimated to be
worth US$4.9 billion in 2005 (Source: Wood Mackenzie's Product View April 2006).
Enquiries
For more information contact:
Maureen Lindsay + 44 (0) 131 226 8550
Ardana
Julia Phillips/John Gilbert +44 (0) 20 7831 3113
Financial Dynamics
(corporate and financial media relations)
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
out-licensing to maintain a robust pipeline.
Ardana's four lead products are summarised below:
• Emselex(R), a once a day treatment for the symptoms of overactive bladder
which Ardana has exclusive UK marketing and promotion rights and is being
distributed in collaboration with Novartis Pharmaceuticals 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;
• Invicorp, an injectable combination drug treatment for erectile
dysfunction, for which Ardana has marketing and manufacturing rights in
Europe;
• Teverelix LA, in development for three initial indications (prostate
cancer, BPH and endometriosis);
• Testosterone Cream, a transdermal testosterone delivery system in
development for the treatment of male hypogonadism, in Phase II trials; and
• Oral GHS (EP01572) a oral growth hormone secretagogue in late stage
development in the first indication for the diagnosis of growth hormone
deficiency and in early stage development in a second indication.
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
*Source: IMS Retail Drug Monitor November 2005.
Statements contained within this press release may contain forward-looking
comments which involve risks and uncertainties that may cause actual results to
vary from those contained in the forward-looking statements. In some cases, you
can identify such forward-looking statements by terminology such as 'may', '
will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', '
estimates', 'predicts', 'potential', or 'continue'. Predictions and
forward-looking references in this press release are subject to the satisfactory
progress of research which is, by nature, unpredictable. Forward projections
reflect management's best estimates based on information available at the time
of issue.
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