Under the terms of the agreement, Quintiles' commercialization unit, Innovex, will provide a dedicated team of as many as 75 sales representatives for a two-and-a-half year term. Quintiles' strategic investment group, PharmaBio Development, will invest $15 million to be paid to Columbia over a 15-month period commencing with the signing of this agreement. In return, Quintiles will receive a 9% royalty on net sales of Striant in the United States up to agreed levels of annual sales revenues, and a 4.5% royalty of net sales above those levels. The royalty term is seven years. Royalty payments will commence with the launch of Striant and are subject to minimum and maximum amounts. Columbia will be responsible for product distribution, regulatory and medical affairs, marketing and manufacturing.

"We are pleased to extend our relationship with Quintiles to include sales activities for Striant," said Fred Wilkinson, Columbia's president and chief executive officer. "Their rigorous analysis and review of our NDA submission and marketing plan and resultant commitment to provide funding for the launch highlight both parties' confidence in the prospects for the approval of and commercial opportunity for this innovative product. Upon approval, Striant will be introduced into this rapidly growing and highly unsatisfied market where new approaches to therapy have historically been well received by both patients and physicians. This commercialization agreement with Quintiles represents an important opportunity to address a significant unmet healthcare need with an important and convenient therapeutic alternative for patients."

Ron Wooten, President, PharmaBio Development, said: "The agreement with Columbia reflects continued marketplace demand for strategic and investment partnerships with Quintiles, and also underscores Innovex's continued solid performance as a part of Columbia's women's health sales team. In combining the financial and commercialization resources of PharmaBio Development and Innovex, Quintiles offers the strategic solutions that help enhance the delivery of healthcare products from dynamic and forward-thinking companies like Columbia."

About Striant
Columbia's Striant testosterone buccal bioadhesive product is a controlled- and sustained-release bioadhesive tablet containing 30 mg of testosterone. The tablet adheres to the patient's gum and allows the slow release and absorption of testosterone. Striant utilizes Columbia's patented Bioadhesive Delivery System (BDS) and hydrating buccal technology platforms. It is estimated that hypogonadism affects between four and five million men in the United States, approximately one million of whom currently receive treatment.

About Columbia
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, 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. For more information, visit

About Quintiles
Quintiles Transnational helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Headquartered near Research Triangle Park, N.C., Quintiles is a member of the S&P 500 and Fortune 1000. For more information, visit the company's Web site at www.quintiles.com.

This press release contains forward-looking statements regarding Quintiles and Columbia that involve risks and uncertainties that could cause actual results to differ materially. The risks and uncertainties with respect to Quintiles include, without limitation, the risk that the market for Quintiles' products and services will not grow as expected, the risk that PharmaBio transactions will not generate revenues or profit at the rate or levels anticipated or that royalty revenues under PharmaBio agreements may not be adequate to offset Quintiles' up front and ongoing expenses in providing sales and marketing services or in making milestone and marketing payments, actual operating performance, changes in trends in the pharmaceutical industry, and the ability to operate successfully in new lines of business. The risks and uncertainties with respect to Columbia include, without limitation, the successful marketing of Crinone® by Columbia's licensee, Serono; the successful marketing of Prochieve™, RepHresh Vaginal Gel™, and Advantage-S® by Columbia; the timely and successful development of products; timely and successful completion of clinical studies; success in obtaining acceptance and approval of new products by the FDA and international regulatory agencies; and competitive economic and regulatory factors in the pharmaceutical and healthcare industry. Quintiles and Columbia are subject to the risks of whether Striant™ will receive FDA approval or prove to be commercially successful. Additional factors that could cause actual results to differ materially are discussed in Quintiles' and Columbia's recent filings with the Securities and Exchange Commission, including but not limited to each company's Annual Report on Form 10-K, its Form 8-Ks, and its other periodic reports, including Form 10-Qs