ARA Aura Renewable Acquisitions Plc

RNS Number:5364R
Ardana PLC
21 September 2005

ARDANA ACCELERATES ANTICIPATED LAUNCH OF TEVERELIX LONG ACTING (LA) IN BENIGN
PROSTATIC HYPERPLASIA FOLLOWING PRE-IND MEETING WITH THE US FDA


Edinburgh, UK, 21 September 2005: Ardana plc (LSE:ARA), the emerging
pharmaceutical company focused on improving human reproductive health, today
reports that the launch of its lead compound, the GnRH antagonist Teverelix Long
Acting (LA) in benign prostatic hyperplasia (BPH), could be advanced by up to
two years, following a pre-Investigational New Drug (IND) application meeting
with the FDA at which consensus on the company's development plan for the
therapy was reached.  It was previously expected that Teverelix in BPH could
reach the market in 2012.


In a recent Phase II study in patients with BPH, Teverelix LA demonstrated a
statistically significant improvement in symptoms of BPH as measured by the
International Prostate Symptom Score (IPSS). The FDA has confirmed that
improvements in symptoms according to IPSS can serve as a single endpoint for
therapeutic and regulatory success.


Ardana is planning to submit its first study under this IND to the FDA within
the next few months.  Another European  Phase II study in patients with BPH is
expected to commence before the end of 2005.  If all future development goes to
plan, the company anticipates that Teverelix LA may now be launched up to two
years earlier than previously anticipated.


Dr Maureen Lindsay, Chief Executive Officer of Ardana, said "We are very
encouraged by the feedback we have had from the FDA, which follows the positive
view we recently received at a pre-IND meeting for Teverelix LA in prostate
cancer.  The opportunity to bring forward the launch date for BPH is very
exciting for ourselves and potential partners.  We look forward to announcing
further progress with the Teverelix programme including a third indication of
Endometriosis."


For more information contact:

Ardana                                 Financial Dynamics
Maureen Lindsay                        (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550             Julia Phillips/Davina Langdale
                                       Tel: +44 (0)20 7831 3113

                                       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 that has already been
    launched by Ardana through its own sales force in the UK as a treatment for
    men with hypogonadism and for which Ardana has marketing rights in Europe;
  * Teverelix LA, in development for three initial indications (prostate
    cancer, benign prostatic hyperplasia and endometriosis);
  * Testo Bi-gel, a trans dermal testosterone delivery system in development
    for the treatment of male hypogonadism, shortly to enter Phase II trials;
  * Invicorp, an injectable combination drug treatment for erectile
    dysfunction, for which Ardana has marketing and manufacturing rights in
    Europe.


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
END

RESVBLFLEKBLBBV

Aura Renewable Acquisiti... (LSE:ARA)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024

Aura Renewable Acquisiti... (LSE:ARA)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024