ARDANA ANNOUNCES COMPLETION OF EUROPEAN MUTUAL
RECOGNITION PROCESS FOR Striant™ TESTOSTERONE REPLACEMENT THERAPY
IN MEN WITH PRIMARY OR SECONDARY HYPOGONADISM
- European Roll Out Anticipated From Second Quarter 2005
-
Edinburgh, UK; 27 October 2004 …….Ardana
Bioscience, the emerging pharmaceutical company dedicated to improving
reproductive health is pleased to announce that its partner, the
US pharmaceutical company Columbia Laboratories, Inc., (NASDAQ:
CBRX) has completed the European Mutual Recognition Process for
Striant™, the first buccal (gum surface) tablet testosterone
replacement therapy for men with primary or secondary hypogonadism.
Dr Maureen Lindsay, Ardana Chief Executive Officer said ‘This
is a key milestone for Ardana and Columbia and we are delighted
to receive a positive opinion from all major markets including
Germany, France, Spain, Portugal, Italy and the Scandinavian countries.
Ardana received UK marketing authorization and license for Striant™
in April this year and our specialist sales force have begun to
market the product here. After conversion into national marketing
authorisations across Europe, we anticipate product roll-out will
begin in the second quarter of 2005.’
Striant™ is the first gum surface product for testosterone replacement
therapy in men with primary or secondary hypogonadism (ie those
suffering from a deficiency or absence of testosterone) and it
provides patients and clinicians with a new, discreet treatment
option.
Striant™ delivers testosterone through the gum and cheek surfaces
that are in contact with the tablet and directly into the bloodstream,
avoiding first pass liver metabolism. The tablet is applied to
the gum twice daily (bd) at twelve hour intervals eg once in the
morning and once in the evening. Once in place, it adheres, softens
into a gel-like form and delivers consistent, controlled and sustained
levels of mean serum total testosterone that approximate the physiological
levels seen in healthy young men *1-3.
Male Hypogonadism (which is characterised by testosterone levels
below the normal range) can be caused by conditions associated
with the testes, pituitary gland or hypothalamus gland, or by
a genetic disorder. Signs and symptoms of hypogonadism can include
decreased libido (sexual desire), erectile dysfunction, fatigue,
depression, reduced muscle mass and osteoporosis. Testosterone
replacement therapy is designed to provide and maintain normal
levels of testosterone.
Ardana acquired key European rights to Striant™ from Columbia
Laboratories, Inc. in October 2002. Mipharm, S.p.A. will be responsible
for commercialising Striant™ in Italy.
For more information contact:
Maureen Lindsay or Lyn Cranwell – Ardana -
+ 44 (0) 131 226 8550
Julia Phillips, Financial Dynamics (corporate and financial
media relations):
+44 (0)20 7831 3113
Nicki Brimicombe, NB Public Relations, (trade and technical
media relations):
+ 44 (0)1883 732353
* 1. Wang C, Swerdloff R, Kipnes M, et al. New testosterone buccal
system (Striant) delivers physiological testosterone levels. Pharmacokinetics
study in hypogonadal men. J Clin Endocrinol Metab 2004;89: 3821-3829.
2. Dobs AS, Matsumoto AM, Wang C, Kipnes MS. Short-term pharmacokinetic
comparison of a novel testosterone buccal system and a testosterone
gel in testosterone deficient men. Curr Med Res Opin 2004;20:729–738.
3. Korbonits M, Slawik M, Cullen D, et al. A comparison of a novel
testosterone bioadhesive buccal system, Striant, with a testosterone
adhesive patch in hypogonadal males. J Clin Endocrinol Metab 2004:89:2039–2043.
Notes for Editors
Ardana Limited is an emerging pharmaceutical company with a specialised
focus on reproductive health. The company aims to become a leading
source of clinical and commercial innovation in the $20 billion
human reproductive health market, which is growing at 9% per annum.
In addition to Striant™ , the company has marketing and manufacturing
rights in Europe and EFTA for Invicorp®, a patented combination
drug treatment for male erectile dysfunction. Ardana also has
a rich development portfolio including the Gonadotrophin Releasing
Hormone (GnRH)-antagonist, Teverelix LA, in Phase II trials in
patients with prostate cancer and benign prostate hyperplasia;
Chronodyne® (terbutaline) which is in Phase I/II trials for
endometriosis-related infertility (being developed in collaboration
with Columbia Laboratories; and a reformulation of the GnRH analog
'Leuprorelin' which has completed Phase II trials for prostate
cancer.
Ardana's therapeutic interests encompass androgen replacement,
prostatic disease, infertility, sexual dysfunction and obstetrics.
The company has exclusive rights to commercialise research by
the Medical Research Council (MRC)'s Human Reproductive Sciences
Unit (HRSU) in Edinburgh, Scotland, which has been at the forefront
of this area of research for the last 30 years. The HRSU contributes
a significant number of early stage development projects to the
Ardana development portfolio, which complement later stage and
marketed products. The MRC employs nearly 100 staff at the Unit,
which currently receives total annual funding of £3.8 million.
Ardana has raised £43.4 million in four funding rounds.
Ardana investors include DVC Deutsche Venture Capital, Albany
Venture Managers Limited and 3i Bioscience Investment Trust, Merlin
Biosciences Limited, MVM Limited (MVM), Techno Venture Management
(TVM), ABN-AMRO Participates, 3i Group plc, ISIS Equity Partners
plc, Scottish Widows Investment Partnership Ltd, Saffron Hill
Ventures, Mitsubishi Corporation and Green Highlander, LLC. www.ardana.co.uk
Statements contained within this press release may contain forward-looking
comments which involve risks and uncertainties that may cause
actual results to vary from those contained in the forward-looking
statements. In some cases, you can identify such forward-looking
statements by terminology such as ‘may’, ‘will’,
‘could’, ‘forecasts’, ‘expects’,
‘plans’, ‘anticipates’, ‘believes’,
‘estimates’, ‘predicts’, ‘potential’,
or ‘continue’. Predictions and forward-looking references
in this press release are subject to the satisfactory progress
of research which is, by nature, unpredictable. Forward projections
reflect management’s best estimates based on information
available at the time of issue.
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