Columbia Laboratories Submits U.S. New Drug Application for Crinone, Its Locally-Delivered Natural Progesterone Gel

Business Wire, July 24, 1996

MIAMI--(HealthWire)--July 24, 1996--Columbia Laboratories, Inc. (ASE: COB) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for clearance to market Crinone(R), its locally-delivered natural progesterone gel, as a hormonal therapy for patients with secondary amenorrhea (loss of menstrual period). Through Columbia's patented Bioadhesive Delivery System, Crinone is the first product to deliver progesterone directly to the uterus, thereby maximizing therapeutic benefit and avoiding side effects seen with orally-delivered synthetic progestins. If cleared for marketing by the FDA, Crinone will be the first locally-delivered natural progesterone gel available in the U.S.

"Based on results from the Phase III clinical studies performed in the U.S., we expect a speedy review at the FDA," said William J. Bologna, Chairman of Columbia Laboratories. "We have also completed clinical trials with Crinone for application in assisted reproduction to treat infertility in women, and will submit an additional NDA for this indication later this year."

The first regulatory approval for Crinone as a prescription drug was received in the U.K. in June 1995. Approved indications in the U.K. include the prevention of hyperplasia and endometrial cancer in post-menopausal women receiving hormone replacement therapy (HRT), use in in vitro fertilization procedures, infertility due to inadequate progesterone production, reduction of the symptoms of premenstrual syndrome (PMS), menstrual irregularities, dysmenorrhea and dysfunctional uterine bleeding, and infertility due to inadequate luteal phase (insufficient progesterone production). Regulatory authorities in Finland and Ireland have also approved Crinone for these indications. In France, Crinone is approved for use in in vitro fertilization procedures and approvals for additional indications are expected during 1996. Approvals in Germany, Italy, Belgium, Holland, Scandinavia, Greece and Portugal are also expected during 1996.

In April, Columbia reported favorable results from three pivotal Phase III studies which examined the effects of two doses of Crinone, 45 mg. and 90 mg., in 110 women with secondary amenorrhea. All patients were first given only estrogen to prime the endometrium (lining of the uterus). Approximately 80 percent of patients had the expected menstruation after both doses of Crinone. In addition, biopsies confirmed that 94 percent of patients in the 45 mg. group and 100 percent of patients in the 90 mg. group had endometrial changes consistent with normal progestational activity. In addition, common side effects associated with synthetic progestins, such as depression, emotional lability, sleep disorders, headache and bloating, decreased when Crinone was taken with estrogen.

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.

305/860-1692 212/505-1919

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