Columbia Laboratories Announces Issuance of Patent Covering Novel Bioadhesive Drug Delivery Technology For Crinone, Its Natural Progesterone Gel Product.

MIAMI--(HealthWire)--August 6, 1996--Columbia Laboratories, Inc. (ASE: COB) today announced the issuance of U.S. Patent No. 5,543,150 covering the technology used in its vaginally-delivered natural progesterone gel, Crinone(R), to allow the sustained and targeted vaginal delivery of progesterone to the uterus. This new patent protects Crinone in the United States until 2013. Prior to the granting of this patent, the basic Columbia bioadhesive delivery technology patent, issued in October 1986, safeguarded the basic technology in the delivery system used in Crinone and Columbia's other bioadhesive products.

Columbia's bioadhesive delivery system enables Crinone to produce a secretory transformation of the endometrium, the lining of the uterus, at low serum progesterone levels. Secretory transformation of the endometrium is necessary for proper implantation of an embryo in the uterus, as well as for protection against uterine cancer in menopausal women receiving estrogen therapy. Columbia characterizes this phenomenon of endometrial transformation at low serum progesterone levels as an example of the First Uterine Pass Effect(TM).

"We look forward to a long period of exclusivity for Crinone, a product we believe to be a breakthrough in women's health care," said William J. Bologna, Chairman of Columbia Laboratories. "We expect similar patents to issue in the rest of the world to further strengthen our proprietary position for this technology."

Clinical benefits of the First Uterine Pass Effect have been demonstrated in the three pivotal Phase III trials which led to the filing of an NDA for Crinone in the United States in July. In a study of 110 women with secondary amenorrhea, approximately 80% had the expected menstruation after the first cycle of both doses of Crinone (45mg and 90mg) every other day. In addition, biopsies confirmed that 94% of the patients in the 45mg group and 100% of the patients in the 90mg group had endometrial changes consistent with normal progestational activity. Most importantly, fewer women experienced new side effects when Crinone was added to their estrogen therapy than when they took estrogen alone.

Columbia has previously announced that Crinone will be marketed worldwide by Wyeth-Ayerst, a division of American Home Products.

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company, dedicated to the development of women's prescription and over-the-counter products, including those which help prevent sexually transmitted diseases. Columbia's products primarily utilize the Company's patented bioadhesive delivery technology.

CONTACT: Margaret J. Roell Karen Bergman (media)

Chief Financial Officer Reagan Codner (investors)

Columbia Laboratories, Inc. Burns McClellan, Inc.

[phone] [phone]