COLUMBIA LABORATORIES RENEWS AGREEMENT WITH MERCK SERONO FOR CRINONE IN FOREIGN MARKETS LIVINGSTON, NJ— May 18, 2010—Columbia Laboratories, Inc. (Nasdaq: CBRX) has renewed its license and supply agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for CRINONE® (progesterone gel) for an additional five-year term. Under the existing agreement and the renewal, Merck Serono has marketing rights worldwide, except the United States. CRINONE is currently approved in 63 countries, including China, where it was approved at the end of 2008. “We are pleased to continue our longstanding relationship with Merck Serono for CRINONE,” said Frank C. Condella, Jr., Columbia’s president and chief executive officer. “We expect sales volumes will be higher this year than in 2009, primarily due to growth in China and other emerging growth markets. We therefore look forward to a good royalty stream in 2010 and beyond as Merck Serono continues building CRINONE’s presence in current markets and expanding its geographic reach." The terms of the renewed license and supply agreement are not materially different from the prior agreement. Merck Serono holds marketing rights to CRINONE for all countries except the United States. Columbia retains United States marketing rights to the CRINONE and PROCHIEVE brands of progesterone vaginal gel products. Columbia announced on March 4, 2010, that it had entered into a Purchase and Collaboration Agreement to sell the United States rights to CRINONE and PROCHIEVE to Watson Pharmaceuticals, Inc. (NYSE: WPI), subject to approval by Columbia’s shareholders and other closing conditions. ABOUT CRINONE CRINONE® 8% (progesterone gel) is primarily used for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with a progesterone deficiency. Patient preference for CRINONE® 8% has been demonstrated in five clinical trials. This product is also available under the trade name PROCHIEVE®. For more information, please visit www.crinoneusa.com. Columbia is conducting, in collaboration with the NIH, a Phase III clinical program, called the PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study, to evaluate the safety and efficacy of PROCHIEVE® 8% to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint of the study is a reduction in the incidence of preterm birth at less than or equal to 32 weeks gestation vs. placebo. Preterm birth occurs in one of every eight live born infants, and short cervix is the single most important predictor of preterm birth. There are currently no products approved for the prevention of preterm birth.
The most common side effects of CRINONE® 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE® 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs.
ABOUT COLUMBIA LABORATORIES Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the women’s healthcare and endocrinology markets that use its novel bioadhesive drug delivery technology. Columbia’s United States sales organization markets CRINONE® 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency and STRIANT® (testosterone buccal system) for the treatment of hypogonadism in men. Columbia's partners market CRINONE ® 8% and STRIANT® to foreign markets.
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Additional Information about the Watson Transactions and Where to Find It This communication is not a solicitation of a proxy from any security holder of Columbia. In connection with stockholder approval of the sale of the assets contemplated by the Purchase and Collaboration Agreement and certain other matters, Columbia has filed with the SEC a preliminary proxy statement and intends to file a definitive proxy statement and to mail to its security holders a definitive proxy statement and other materials. THE PROXY STATEMENT WILL BE SENT TO COLUMBIA SECURITY HOLDERS AND WILL CONTAIN IMPORTANT INFORMATION ABOUT COLUMBIA, WATSON, THE SALE OF THE ASSETS PURSUANT TO THE PURCHASE AND COLLABORATION AGREEMENT, AND RELATED MATTERS. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY WHEN THEY ARE AVAILABLE BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED SALE OF THE ASSETS AND THE OTHER MATTERS DESCRIBED THEREIN. Free copies of the proxy statement and other documents filed with the SEC by Columbia, when they become available, can be obtained through the website maintained by the SEC at www.sec.gov. In addition, free copies of the proxy statement will be available from Columbia by contacting Lawrence A. Gyenes at (973) 486-8860 or lgyenes@columbialabs.com, or on Columbia’s investor relations website at www.cbrxir.com.
Participation in the Solicitation Columbia and its directors and executive officers and certain other members of management may be deemed to be participants in the solicitation of proxies from Columbia's stockholders in connection with the proposed transactions described herein. Information regarding the special interests of these directors, executive officers and members of management in the proposed transactions will be included in the proxy statement and other relevant documents filed with the SEC. Additional information regarding Columbia’s directors and executive officers is also included in Columbia’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2009, which was filed with the SEC on April 30, 2010. Columbia’s Form 10-K/A is available free of charge at the SEC’s website at www.sec.gov and from Columbia by contacting it as described above.
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