Emselex Endorsement
June 11 2007 - 3:01AM
UK Regulatory
RNS Number:0846Y
Ardana PLC
11 June 2007
ARDANA ANNOUNCES POSITIVE ASSESSMENT OF EMSELEX(R) BY SCOTTISH MEDICINES
CONSORTIUM
Edinburgh, UK, 11 June 2007: Ardana plc (LSE:ARA), today announces a positive
opinion from the Scottish Medicines Consortium (SMC) about Emselex (darifenacin
hydrobromide). Emselex is a once a day oral treatment for the symptoms of
overactive bladder (OAB). A positive opinion by the SMC is essential for the
introduction of new therapies within NHS Scotland.
The OAB market in the UK is currently estimated to be approximately #90 million
per annum, of which Scotland contributes #10.5 million (IMS Health).
Dr. Maureen Lindsay, Chief Executive of Ardana, said: "We are delighted that the
SMC assessment of Emselex has been favourable. This will help us to continue to
gain acceptance for Emselex as an important new treatment option for patients
with OAB" .
Emselex was launched in October of last year and is marketed in collaboration
with Novartis Pharmaceuticals UK Limited ("Novartis").
Emselex(R) works by selectively inhibiting the muscarinic M3 receptor, the
primary mediator of detrusor muscle contraction. 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).
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 some patients.
In common with other recently introduced antimuscarinic treatments for OAB, the
positioning of Emselex takes into account cost considerations. The SMC advice,
following a full submission reads:
"darifenacin (Emselex(R)) is accepted for restricted use within NHS Scotland
for the symptomatic treatment of urge incontinence and/or increased urinary
frequency and urgency as may occur in patients with overactive bladder syndrome.
Darifenacin is effective in reducing symptoms associated with overactive
bladder, including frequency, urgency and incontinence and the treatment effect
is similar to another antimuscarinic. Darifenacin is associated with adverse
effects typical of antimuscarinic agents used in this condition. It is
restricted to second line use as there are cheaper antimuscarinics available
that would normally be used as first-line agents"
Full details of the advice are available at the SMC website:
www.scottishmedicines.org.uk
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 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:
* Emselex(R), a once a day treatment for the symptoms of overactive bladder
syndrome, for which Ardana has exclusive UK marketing and promotion rights
and is being distributed in collaboration with Novartis UK Limited;
* Teverelix LA, in development for three initial indications (prostate
cancer, benign prostatic hyperplasia and endometriosis);
* ARD-07 a growth hormone secretagogue in late stage development for the
diagnosis of growth hormone deficiency
* 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;
* Testosterone Cream, a trans dermal testosterone delivery system in
development (Phase II trials) for the treatment of male 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 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
END
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