Columbia Laboratories submits additional U.S. New Drug Application for Crinone, its vaginally delivered natural progesterone gel.

MIAMI--(BUSINESS WIRE)--Nov. 13, 1996--

-- Nine month results also reported --

Columbia Laboratories Inc. (ASE:COB) Wednesday announced the submission of a second New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for clearance to market Crinone(r), its vaginally delivered natural progesterone gel, for use in Advanced Reproductive Technologies (ART) procedures, including in-vitro fertilization, ovum donation and stimulated cycles.

In July, Columbia filed a NDA for clearance to market Crinone 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 vaginally delivered natural progesterone gel available in the U.S.

"Based on the results from the Phase III clinical studies performed in the U.S. which showed pregnancy rates of approximately 50% and that there are no approved natural progesterone products for this indication, we expect a speedy review at the FDA," said William J. Bologna, chairman of Columbia Laboratories. "In addition, the only currently available methods to administer natural progesterone are intramuscular injections or suppository formulations, both of which are difficult to administer and give inconsistent results."

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, 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 the next year.

Columbia also reported a net loss of $8,808,862, or $.32 per share for the nine months ended Sept. 30, 1996, as compared to net income of $2,748,781 or $.11 per share for the comparable 1995 period. The 1996 results include $2 million, and the 1995 results include $8 million, of license fees received from Wyeth-Ayerst in connection with the strategic alliance agreement for Crinone(r). Sales for the nine month period ended Sept. 30, 1996 were $3,731,348 as compared to $7,970,001 in 1995. 1995 sales include the initial stocking orders of Legatrin PM.

For the three months ended Sept. 30, 1996, the company reported a net loss of $3,394,872 or $.12 per share, as compared to a net loss of $2,459,314 or $.10 per share for the comparable 1995 period. The 1996 results include $500,000 of the aforementioned license fees received from Wyeth-Ayerst in connection with the Crinone strategic alliance agreement. Sales for the three month period ended Sept. 30, 1996 were $1,325,868 as compared to $1,886,135 in 1995.

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. -0-

           COLUMBIA LABORATORIES INC. AND SUBSIDIARIES
         CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                          (Unaudited)

                        Nine Months Ended       Three Months Ended
                           Sept. 30,                Sept. 30,
                        1996      1995           1996      1995

NET SALES            $3,731,348  $7,970,001  $1,325,868  $1,886,135

COST OF GOODS SOLD    2,070,992   4,099,040     798,128     902,026
 Gross profit         1,660,356   3,870,961     527,740     984,109

OPERATING EXPENSES:
 Selling and
  distribution        2,220,872   2,283,150     802,240     834,687
 General and
  administrative      2,516,189   2,273,295     863,735     701,241
 Research and
  development         8,027,727   4,671,182   2,876,453   1,946,097
    Total operating
     expenses        12,764,788   9,227,627   4,542,428   3,482,025

    Loss from
     operations     (11,104,432) (5,356,666) (4,014,688) (2,497,916)

OTHER INCOME (EXPENSE):
 License fees         2,018,205   8,054,883     518,205          --
 Interest income        299,838      99,167     106,575      58,962
 Interest expense       (15,819)   (166,824)     (8,698)    (26,074)
 Other, net              (6,654)    118,221       3,734       5,714
                      2,295,570   8,105,447     619,816      38,602

    Net income
     (loss)         $(8,808,862) $2,748,781 $(3,394,872)$(2,459,314)

NET INCOME (LOSS)
 PER COMMON SHARE         $(.32)        $.11      $(.12)      $(.10)

WEIGHTED AVERAGE
 NUMBER OF COMMON
 SHARES OUTSTANDING  27,463,000   25,326,000  28,031,000  25,726,000


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        CONFERENCE CALL WITH COLUMBIA LABORATORIES INC.

      You are invited to participate in a conference call
                 with Columbia Laboratories
                to discuss the filing of its
                Second New Drug Application
         with the U.S. Food and Drug Administration
             for clearance to market Crinone(r)
         for use in Advanced Reproductive Technologies

           William J. Bologna, Chairman of the Board
      Norman M. Meier, President and Chief Executive Officer
       Nicholas A. Buoniconti, Vice Chairman of the Board

               will hold the conference call on

                   Thursday, Nov. 14, 1996
               11:30 a.m. Eastern Standard Time

If you wish to participate, please call 212/346-0246 or
1-800-621-5175 and ask to be connected to the Columbia call.

A playback of the conference call will be available through
5:00 p.m. Eastern Standard Time on Friday, Nov. 15 by dialing
1-800-633-8284 and providing reservation number 2175480.

Should you have any questions, please contact Peggy Roell at
305/860-1692.

CONTACT: Columbia Laboratories Inc., Miami

Margaret J. Roell, Chief Financial Officer

305/860-1692