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Columbia Signs Supply Agreement With Mipharm S.p.A. for Testosterone Buccal Tablet.


Business Editors/Health & Medical Writers

LIVINGSTON, N.J.--(BUSINESS WIRE)--May 30, 2002

Companies Expand Development Agreement for Women's Health Women's Health Definition

Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
 Products

Columbia Laboratories, Inc (AMEX AMEX

See: American Stock Exchange
: COB) today announced that its Bermuda subsidiary, Columbia Laboratories (Bermuda), Ltd., has finalized a non-exclusive supply agreement with Mipharm S.p.A. for the manufacture and supply of commercial forms of Columbia's testosterone testosterone (tĕstŏs`tərōn), principal androgen, or male sex hormone. One of the group of compounds known as anabolic steroids, testosterone is secreted by the testes (see testis) but is also synthesized in small quantities in the  buccal buc·cal
adj.
1. Of, relating to, adjacent to, or in the direction of the cheek.

2. Of or relating to the mouth cavity.


buccal
 tablet.

Under the terms of this agreement, Mipharm will supply Columbia with most of its requirements for product for all worldwide markets, and will also serve as the licensee of the testosterone buccal tablet in Italy.

Columbia further announced the execution of a letter of intent with Mipharm for the development of additional products utilizing Columbia's patented bioadhesive technology, focusing on select women's health products, including anti-fungals, anti-infectives, and anti-inflammatories. Columbia will retain marketing rights for the U.S. and most other countries to any new products developed by Mipharm, while Mipharm will have commercial rights in Italy. Mipharm will also receive a right of first refusal Right of First Refusal

In general, the right of a person or company to purchase something before the offering is made available to others.

Notes:
For example, a football team may have the right of first refusal on a player's contract.
 for the commercialization of these products in major countries in the Mediterranean region.

"We are pleased with the expansion of our relationship with Mipharm, which has a strong marketing presence in Italy, and to include them as one of our marketing partners for our novel testosterone buccal tablet outside the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. ," commented Fred Wilkinson, Columbia's president and chief executive officer. "Mipharm has an excellent research and development team which will be critical to the progress of other products through the development stage and its strong manufacturing capabilities will be important to the success of our testosterone product launch."

Dr. G. G. Miglio, founder, chairman and chief executive officer of Mipharm added, "We are proud to further strengthen our partnership with Columbia Laboratories. The new testosterone buccal tablet demonstrates how the synergy between innovative technology and research and development excellence brings about new important market opportunities. The testosterone buccal tablet allows Mipharm to enter, with Columbia's bioadhesive delivery system (BDS BDS
abbr.
Bachelor of Dental Surgery


BDS Bachelor of Dental Surgery

BDS n abbr (= Bachelor of Dental Surgery) → título universitario

BDS 
) technology, into the growing male therapy segment of the market, adding to Mipharm's existing selected products in women's health."

Columbia has successfully completed the two pivotal trials needed for the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  submission in the US and the mutual recognition file in Europe for its testosterone buccal tablet and intends to file an NDA with the US Food and Drug Administration and a marketing authorization submission in the UK in mid-year 2002.

Columbia Laboratories, Inc., is a U.S.-based international pharmaceutical company dedicated to research and development of women's health care and endocrinology products, including those intended to treat infertility, dysmenorrhea dysmenorrhea

Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur.
, endometriosis endometriosis (ĕn'dəmē'trē-ō`sĭs), a condition in which small pieces of the endometrium (the lining of the uterus) migrate to other places in the pelvic area.  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.

Mipharm S.p.A., based in Milan, Italy, is an independent pharmaceutical company focused on dermatology/skin care, gynecology/women's health, and special care. The company has an FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approved manufacturing facility that supplies products for sale throughout Europe and the U.S. for large pharmaceutical companies. Mipharm was founded in January 1998, by Dr. Giuseppe G. Miglio (formerly President of the Pharmaceutical Business of Novartis in Italy and President and Chairman of Sandoz Holding, Italy) with a spin-off from Novartis' Milan technical production facility. New technology delivery systems that improve upon traditional systems and add value to effective and well known compounds are one of Mipharm's strengths.

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, the successful marketing reintroduction Noun 1. reintroduction - an act of renewed introduction
intro, introduction, presentation - formally making a person known to another or to the public
 of Crinone, the timely and successful development of products, timely and successful completion of clinical studies, success in obtaining FDA acceptance and approval of a testosterone NDA, competitive economic and regulatory factors in the pharmaceutical and health care industry, the outcome of the Serono litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
, and 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.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:May 30, 2002
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