News

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.

back to top

Archived News