Ardana PLC
16 November 2006
ARDANA ANNOUNCES UK LAUNCH OF EMSELEX(R)
FOR OVERACTIVE BLADDER
Edinburgh, UK, 16 November 2006L: Ardana plc (LSE:ARA), announces today that it
has commenced the marketing in the United Kingdom of Emselex(R), a once a day
treatment for symptoms of overactive bladder (OAB) in collaboration with
Novartis Pharmaceuticals UK Limited ('Novartis').
Ardana will be responsible for the launch and ongoing sales and marketing of
Emselex(R) whilst Novartis will be responsible for distribution, medical and
pharmacovigilance activities. This follows the announcement on 20th September
2006 of an exclusive 10 year UK marketing and promotion agreement between Ardana
and Novartis Pharmaceuticals UK Limited and a Placing and Open Offer raising
£11.0 million (gross), part of the net proceeds of which were to be used to
launch and promote this product.
The OAB market in the UK is currently estimated to be £82.1 million and is
growing at 14% per annum (IMS Health).
Dr. Maureen Lindsay, Chief Executive of Ardana, said:
'We are delighted to have launched Emselex(R) today as it is an important new
treatment option for patients who suffer from this distressing condition.'
Emselex(R) (darifenacin hydrobromide) is an oral once-daily muscarinic M3
selective receptor antagonist (M3 SRA) for the treatment of OAB. Symptoms of OAB
include urinary urgency (a sudden and compelling desire to pass urine, which is
difficult to defer) with, or without, urge urinary incontinence (involuntary
leakage accompanied or immediately preceded by urgency), usually with urinary
frequency (voiding the bladder too often), and nocturia (waking at night one or
more times to void the bladder).
Emselex(R) works by selectively inhibiting the M3 receptor, the primary mediator
of detrusor contraction, whilst relatively sparing the M1 and M2 receptors that
are located in various body organs, including the brain and heart. Emselex(R)
has been shown to significantly reduce the number of weekly incontinence
episodes. Pooled data from Phase III studies showed that the incidence of
cardiovascular adverse events for Emselex(R) was low. Furthermore, a study in
elderly healthy volunteers indicated that Emselex(R) did not significantly
impair memory function.
In clinical trials involving more than 10,000 subjects and patients, Emselex(R)
has been shown to significantly improve all other key symptoms of OAB across a
range of pivotal endpoints. These include the number of times patients had to
visit the bathroom each day, frequency of urgency, severity of urgency and the
number of incontinence episodes leading to a change in clothing or pads.
Consistent with the pharmacological profile of Emselex(R) the most commonly
reported adverse events were dry mouth and constipation, but discontinuation
from treatment due to these adverse reactions was infrequent.
Antimuscarinic drugs are often used to treat patients who present with symptoms
of OAB, although other therapies such as bladder retraining may also be
effective.
For more information contact:
Ardana Financial Dynamics
Maureen Lindsay (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550 Julia Phillips/John Gilbert
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 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 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;
• Striant(TM)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
This information is provided by RNS
The company news service from the London Stock Exchange SDLVLELIR
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