FDA Update

Ardana PLC
31 January 2006


ARDANA'S NOVEL TESTOSTERONE CREAM REMAINS ON TRACK FOR Q4 2007 LAUNCH FOLLOWING
                          PRE-IND MEETING WITH US FDA.

        - - Company completes Phase II dose-finding study enrolment - -


Edinburgh, UK, 31 January 2006;  Ardana plc (LSE:ARA) the emerging
pharmaceutical company focused on improving human reproductive health, today
reports on a pre-Investigational New Drug (IND) meeting with the US Food and
Drug Administration (FDA) to discuss the development of its novel cream for
testosterone replacement in male hypogonadism.

Agreement was reached on the next steps in development of the product, which
should allow Ardana to meet its registration timelines and previously announced
launch target of end of 2007.  Ardana is planning to submit an IND to the FDA
within a few months and expects to commence a Phase III pivotal registration
trial in the US at the end of H1 2006.

Additionally, Ardana announces that enrolment to a Phase II dose finding study
in the target patient population has now been completed.  A Phase II
dose-titration study in support of the registration of Ardana's testosterone
cream is also on track to commence in H1 2006.

Dr Maureen Lindsay, Ardana's CEO, said: 'We are very encouraged by the feedback
from the FDA and by the progress of development of this novel testosterone
cream, which complements our current and planned portfolio.  We believe that the
delivery technology has broad application and we are assessing additional
compounds which could be developed using this platform.'

In 2004, the testosterone replacement market in Europe and in the US was
estimated to be worth approximately $600 million.  The US market is by far the
most attractive with a growth rate of 40% by value and sales of $537 million
(IMS Health).


For more information contact:

Ardana                                 Financial Dynamics
Maureen Lindsay                        (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550             Julia Phillips/Davina Langdale
                                       Tel: [phone]

                                       NB Public Relations
                                       (trade/technical media relations)
                                       Nicki Brimicombe
                                       Tel: + 44 (0)1883 732353



About Ardana

Ardana plc is a pharmaceutical company focused on the discovery, development and
marketing of innovative products to improve human reproductive health, a $23.8
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:

  • StriantTM SR, a testosterone replacement therapy for which Ardana has
    marketing rights in Europe, has already been launched by Ardana through its
    own sales force in the UK as a treatment for men with confirmed hypogonadism
  • Teverelix LA, in development for three initial indications: prostate
    cancer and benign prostatic hyperplasia (both indications are at the phase
    II stage), and endometriosis (currently in phase I)
  • Testo Cream, a transdermal testosterone delivery system in phase II for
    the treatment of male hypogonadism
  • Invicorp(R), an injectable combination drug treatment for erectile
    dysfunction, already approved in Denmark and for which Ardana has marketing
    and manufacturing rights in Europe. Launch is expected in H2 2006

In addition, Ardana has a strong portfolio of follow-on products in development.
Ardana completed its IPO on the London Stock Exchange in March 2005 raising
£21 million.

For further information please see www.ardana.co.uk


                      This information is provided by RNS
            The company news service from the London Stock Exchange