
Ardana Acquires Key European Rights To Novel
Testosterone Product From Columbia Laboratories Inc In $8 Million
Deal
Edinburgh, UK, and Livingstone, N.J., US, 17 October
2002
Ardana Bioscience, the emerging pharmaceutical company which
specialises in reproductive health, has acquired key European
rights to a novel testosterone product from the US pharmaceutical
company Columbia Laboratories Inc (ASE symbol COB) in an $8 million
deal.
Through the deal Ardana gains rights to market, distribute and
sell the product in all key European markets, excluding Italy.
The therapy was submitted for final Food and Drug Administration
(FDA) approval in the US in August 2002.
The Columbia product is a controlled and sustained release bioadhesive
tablet containing 30mg of testosterone. Its primary indication
is male hypogonadism, which is experienced by men who naturally
produce insufficient levels of this important hormone. In Europe,
it is estimated that five in every 1,000* men suffer from this
condition, which has been linked to health problems such as cardiovascular
disorders, infertility, Alzheimers and osteoporosis. The novel
tablet is 9mm in diameter and adheres to the patient's gum. Once
applied, the tablet raises testosterone to normal physiologic
levels for 12 hours. It is administered twice daily.
Simon Best, Ardana's Chief Executive Officer commented "This
is another step in our ambitious strategy to rapidly transform
Ardana from a research-based bioscience start-up into a profitable,
high-growth specialty pharmaceutical company which will significantly
improve human reproductive health."
"Ardana has a strong research pipeline and recently acquired
an exciting development portfolio. This new partnership provides
us with a near-to-market product which will be launched first
in the UK in Q1 of 2004. We are delighted that a company of Columbia's
stature and track record has selected Ardana as the partner of
choice to market its key product in Europe. Such partnerships
form part of our long-term strategy to embellish our in-house
product portfolio and secure short-term revenue to support product
development and effective sales and marketing."
Fred Wilkinson, President and Chief Executive Officer of Columbia
stated, "We are pleased to have Ardana as our European marketing
partner for this promising product and we are confident that its
outstanding management team will successfully launch the product
in the key markets within its territory. The Columbia regulatory
team is in the process of completing the necessary steps to submit
the application for regulatory approval in the UK, which will
complement the NDA that we filed with the US FDA in August of
this year. We plan to complete several other similar agreements
which will allow this product to be marketed worldwide".
Global annual sales of products to treat hypogonadism are reported
to be $246 million**. This market is experiencing rapid growth
as a result of the launch of improved formulations that are more
effective and better tolerated by patients. The new tablet will
add to the choices available to doctors and patients and is expected
to fuel further market growth.
ENDS
For more information contact:
Simon Best - Ardana 44 (0) 131 226 8553
Nicki Brimicombe - NB Public Relations (for
Ardana) 44 (0) 1883 732353
James Apostolakis - Vice Chairman Columbia Laboratories
- (001) 212 588 1900
David Weinberg - Chief Financial Officer Columbia
Laboratories - (001) 973 994 3999
Lisa Carlton-Wilson - In-Site Communications
(for Columbia) - (001) 212 759 3929
* Source: Scrip World Pharmaceutical News 2000
** Source: IMS Data 2001
Notes for Editors
Ardana Bioscience is a reproductive health company focused on
obstetrics, sexual dysfunction, contraception and endometriosis/menstrual
disorders. It was created in July 2000 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 28 years. The MRC employs
nearly 100 staff at the Unit which currently receives total annual
funding of £3.8 million. Ardana has two products in clinical
development and a number of pre clinical compounds including those
which address male contraception, female sexual dysfunction and
cervical ripening. Since its inception Ardana has raised £14.6
million (US$21 million approx.) in two funding rounds. Ardana
investors include Merlin Biosciences Limited, MVM Limited (MVM),
ABN-AMRO Capital, 3i, Mitsubishi Corporation and Green Highlander,
LLC. www.ardana.co.uk
Columbia Laboratories
Coumbia Laboratories Inc. is a US based international pharmaceutical
company dedicated to the research and development of women's healthcare
and endocrinology products, including those intended to treat
infertility, dysmenorrhea, endometriosis and hormonal deficiencies.
The company is also developing innovative, new hormonal products
for men and a buccal peptide delivery system. Columbia's products
primarily utilize the company's patented Bioadhesive Delivery
System technology. www.columbialabs.com.
MRC
The Medical Research Council (MRC), established in 1913, aims
to improve health by promoting research into all areas of medical
and related science. It is funded mainly by the government but
is independent in its choice of which research to support. About
half of the MRC's expenditure of approximately £350 million
is invested in over 50 of its Institutes and Units, where it employs
its own research staff. The remaining half goes in the form of
grant support and training awards to individuals and teams in
universities.
MRC Human Reproductive Sciences Unit (HRSU)
Research at the MRC Human Reproductive Sciences Unit is undertaken
at a molecular, cellular and endocrine level to further understand
the regulation of the human reproductive system, with particular
attention to mechanisms that might be exploited for purposes of
contraception or account for infertility, menstrual cycle abnormalities
and disorders of pregnancy and foetal development. Immunological,
hormonal and pharmacological approaches for the reversible regulation
of human fertility are also under investigation. The Unit and
the University of Edinburgh Department of Obstetrics and Gynecology
combine to form the Centre for Reproductive Biology (CRB), a collaborative
institution within the WHO Human Reproduction Programme and the
Rockefeller Foundation Contraception 21 Initiative.
This press release contains statements that constitute forward-looking
statements within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. Those statements include statements regarding
the intent, belief or current expectations of Columbia Laboratories,
Inc., and its management team. Investors are cautioned that any
such forward-looking statements are not guarantees of future performance
and involve risks and uncertainties, and that actual results may
differ materially from those projected in the forward-looking
statements. Such risks and uncertainties include, among other
things, timely and successful completion of clinical studies,
success in obtaining regulatory acceptance and approval of new
products, competitive economic and regulatory factors in the pharmaceutical
and healthcare industry, general economic conditions and other
risks and uncertainties that may be detailed, from time to time,
in reports filed with the Securities and Exchange Commission.
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