ARA Aura Renewable Acquisitions Plc

RNS Number:9053W
Ardana PLC
21 May 2007



       ARDANA'S ORAL GROWTH HORMONE SECRETAGOGUE GAINS ORPHAN DRUG STATUS


Edinburgh, UK, 21 May 2007;  Ardana plc (LSE:ARA) today announces that the US
Food and Drug Administration (FDA) has granted Orphan Drug status for ARD-07,
its oral Growth Hormone Secretagogue (GHS), which Ardana is developing as a
diagnostic for growth hormone deficiency in adults.

The granting of Orphan Drug status in the USA confers a number of advantages
such as eligibility to apply for FDA grants towards clinical development, the
waiving of the User Registration Fee of $896,200 and other registration fees
moving forward.

GHS is a novel synthetic small molecule sized peptidomimetic agent that is
orally active and stimulates the secretion of Growth Hormone (GH) from the
patient's pituitary gland and/or indirectly via stimulation of Growth Hormone
Releasing Hormone (GHRH) from the hypothalamus.

Initial phase I studies have indicated that GHS stimulates growth hormone
secretion in a dose dependent manner following oral and intraduodenal
administration in healthy male subjects.  No apparent adverse effects of GHS on
other hormones such as ACTH, cortisol, ghrelin, insulin and glucose secretion
were observed.

Following meetings with the FDA consensus has been reached that the successful
outcome from one pivotal clinical trial will allow registration of GHS as a
diagnostic for growth hormone deficiency in adults.

The diagnostic clinical development and toxicology programmes are ongoing and,
subject to clinical outcome, the Company anticipates filing for registration at
the end of the year with a possible launch in 2008.  Ardana believes that GHS'
oral formulation will give clinicians a simpler and more effective test for
growth hormone deficiency.

Dr. Maureen Lindsay, Ardana's CEO, said:  "We are delighted and very encouraged
that the FDA have granted Orphan Drug status for GHS.  We believe that GHS could
play a very important role in providing clinicians with a convenient, reliable
and effective diagnostic test for growth hormone deficiency."

In addition to its possible use as a diagnostic, Ardana intends to undertake
clinical trials to support registration of GHS in a number of adult therapeutic
indications.



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
  * 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;
  * 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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