Ardana Bioscience Announces Development Agreement
With Columbia Laboratories For Terbutaline Vaginal Gel Product
Edinburgh, Scotland and Livingston, NJ, US, December
30, 2002
Ardana Bioscience, Ltd. and Columbia Laboratories (AMEX: COB),
announced today that they have executed a development and license
agreement for Columbia's Chronodyne® terbutaline vaginal gel
product in development for the treatment of infertility, dysmenorrhea
and endometriosis. Columbia received a payment of $250,000 upon
signing of the agreement, and will receive an additional $250,000
upon successful completion of the Phase II clinical trial.
Under the terms of the co-development agreement, the two companies
will work together to progress the product through clinical trials
and registration. If it gains regulatory approval, Columbia will
have the right to market the product in North America and Ardana
will have rights focused in Europe. The parties would share equally
in proceeds from licensing and distribution of the product in
the rest of the world.
Simon Best, Ardana's chief executive officer commented, "This
is an excellent strategic move for Ardana and good news for our
customers. It strengthens our reproductive health franchise, broadens
our clinical development portfolio and should provide clinicians
and patients with an innovative therapy to address significant
unmet need".
"We plan to initiate Phase II trials with the new product
in Germany and the U.S. in 2003 and, assuming success, aggressively
progress the Phase III and registration process. The trial protocol
and project management will be undertaken by the Columbia and
Ardana R & D staffs and the clinical group which Ardana acquired
through the Europeptides deal in July 2002. This underlines a
key benefit of both our relationship with Columbia and that acquisition,"
concluded Best.
Fred Wilkinson, president and chief executive officer of Columbia,
stated, "We are pleased to have reached a second agreement
with Ardana, building upon the license and supply agreement for
Columbia's Striant(TM) testosterone buccal bioadhesive product
in eighteen European countries that we announced earlier this
quarter. This new co-development agreement gives Columbia the
opportunity to advance another women's health care product in
the clinic, sharing the development cost with a European partner
with whom we have a strong relationship, while retaining rights
to the product in the U.S., our core market."
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
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.
Columbia Laboratories, Inc. is an international pharmaceutical
company dedicated to research and development of women's health
care and endocrinology products, including those intended to treat
infertility, dysmenorrhea, endometriosis and hormonal deficiencies.
Columbia is also developing hormonal products for men and a buccal
delivery system for peptides. Columbia's products primarily utilize
the company's patented Bioadhesive Delivery System (BDS) technology.
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 the company 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, including Striant(TM)
and Chronodyne®, 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 Columbia's reports filed with the Securities
and Exchange Commission.
Contact: Ardana Bioscience Ltd
Simon Best (0) 44 7884 230 380
Columbia Laboratories, Inc.
James Apostolakis, Vice Chairman
(212) 588-1900
David Weinberg, Chief Financial Officer
(973) 994-3999
NB PR (for Ardana)
Nicki Brimicombe
44 (0) 1883 732353
In-Site Communications, Inc. (for Columbia)
Lisa M. Wilson, Investor Relations/Media Relations
(212) 759-3929
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