RNS Number:3659L
Ardana PLC
09 January 2008




        ARDANA ANNOUNCES OUTCOME OF PRE-IND MEETING WITH FDA ON TEVERELIX LA 
                    FOR THE TREATMENT OF ENDOMETRIOSIS



Edinburgh, UK, January 9, 2008: Ardana Plc (LSE:ARA), the emerging
pharmaceutical company specialising in improving human reproductive health,
today announces the positive outcome of a pre-Investigational New Drug (IND)
meeting with the United States Food and Drug Administration (FDA) for the
development of its lead compound Teverelix LA (long-acting) for the treatment of
endometriosis.

The pre-IND meeting resulted in agreement with the FDA on the clinical
development path for Teverelix LA in this indication. Ardana plans to open an
IND in 2008 and submit the first Phase II study design shortly thereafter.

Endometriosis arises in pre-menopausal women when the lining of the womb
(endometrium) grows outside the uterus, typically in the pelvic cavity. Symptoms
associated with endometriosis include cyclical or chronic pelvic pain, heavy
periods and infertility. It is well documented that endometriosis is a hormone
sensitive condition and a reduction in estrogen levels causes a shrinkage of the
endometriotic lesions and an improvement in symptoms. Current treatment options
include GnRH agonists however this class of compounds is associated with side
effects similar to menopausal symptoms including hot flushes, reduced libido and
loss of bone density, due to the reduction in estrogen levels to those seen in
post-menopausal women.

In two previous Phase I clinical studies of different dose-regimens, Teverelix
LA has been shown to reduce estrogen levels rapidly and in a dose-dependent
manner.  Preliminary data from the second Phase I, randomised, single-blind,
placebo-controlled study of a single subcutaneous injection of Teverelix LA, at
one of two doses to 24 healthy female subjects, indicated that Teverelix LA
could reduce estrogen levels to a desired level at the lower end of the normal
range which should help to avoid  menopausal symptoms.  In this study estrogen
levels were reduced to average concentrations over a period of 8 weeks of 40.5
pg/ml and 49.0 pg/ml respectively vs. 88.8 pg/ml for placebo.

The effect of Teverelix LA on certain bone absorption markers such as serum
telopeptides and urine deoxypyridinoline were also investigated in this study
and these markers appeared to be unaffected by Teverelix LA.

Commenting on today's announcement Dr Huw Jones, Ardana's CEO, said: "We are
encouraged by the feedback we have received from the FDA on the way forward for
Teverelix LA in endometriosis.  There is, in our view, a high unmet medical need
for an effective treatment for endometriosis which does not produce menopausal
symptoms or a loss of bone mineral density."

It has been estimated1 that 1 in 10 women suffer from some form of endometriosis
during their lives and in 2004 it was estimated that there were approximately 17
million cases of endometriosis in the seven major pharmaceutical markets (US,
Japan, France, Germany, Italy, Spain and the UK), of which approximately 3.9
million cases were diagnosed.

Teverelix LA is also being developed for the treatment of prostate cancer and
BPH (benign prostatic hyperplasia) both of which currently have active INDs.
Ardana announced positive Phase II data in both these indications in the second
half of 2007.



1 Source:  Datamonitor July 2004



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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