Columbia Laboratories Initiates U.S. Study in Pregnant Women at High Risk of Preterm Delivery

Columbia Laboratories Initiates U.S. Study in Pregnant Women at High Risk of
Preterm Delivery
Safety and Efficacy of Prochieve(R) 8% (Progesterone Gel) to Prevent Preterm
Delivery Examined 


LIVINGSTON, N.J., Nov. 12  /PRNewswire-FirstCall/ -- Columbia Laboratories, Inc.
 today announced the start of a multicenter U.S. clinical trial designed to
prevent preterm delivery in pregnant women who are at increased risk for preterm
birth.  PROTERM, a 12-center study expected to enroll at least 625 patients,
will compare Prochieve(R) 8% (progesterone gel) vs. placebo in a population of
pregnant women at high-risk for preterm delivery, defined as less than 37
completed weeks of gestation.

"The number of babies born prematurely in this country is rising at an alarming
rate and alternative therapies to the current standard of care are urgently
needed to prevent premature labor and delivery," said Ken Muse, M.D., associate
professor in the Department of Obstetrics and Gynecology at the University of
Kentucky Chandler Medical Center in Lexington, Kentucky and lead investigator of
the PROTERM clinical study.  "Preterm delivery accounts for more than 60 percent
of infant mortality, and is a leading cause of health care expenditures in both
the prenatal period and throughout the life of infant survivors."

"We are hopeful that the PROTERM study will result in an important potential
treatment for women at risk for premature delivery, which has been identified as
one of the most significant health concerns in obstetrics today," said Fred
Wilkinson, Columbia's Chairman, President and Chief Executive Officer.  "The
ability to demonstrate the safety and efficacy of a novel therapy in the
prevention of premature delivery would represent an important milestone in our
ongoing mission of providing women with innovative new products."

Prochieve 8% (progesterone gel) is a bioadhesive product that is approved by the
U.S. Food and Drug Administration (FDA) for progesterone supplementation or
replacement as part of an Assisted Reproductive Technology (ART) treatment for
infertile women with progesterone deficiency.

PROTERM (PROgesterone Gel for Reducing PreTERM Labor and Delivery) is a Phase
III, randomized, double-blind, placebo-controlled, multicenter study that will
assess the efficacy, safety and tolerability of the natural progesterone vaginal
gel, Prochieve 8%, in preventing preterm delivery in pregnant women who have
either a history of a spontaneous preterm delivery, or have a cervical length of
2.5 cm or less, as measured by transvaginal ultrasound with the current
pregnancy.

Prochieve 8% or placebo will be initiated in all randomized patients between 18
and 22 weeks of gestation and administered daily until delivery, withdrawal from
the study, development of preterm rupture of the membranes, or until 37
completed weeks of gestation.  Enrollment is expected to begin later this month
and continue for nine to twelve months with an interim analysis available by
late 2004.

"Since its market introduction in 1997, Columbia Laboratories' patented
progesterone gel has been used by OB/GYNs and fertility specialists to help
infertile women safely and effectively achieve and sustain pregnancy in the
first trimester," said Wilkinson. "Results of this study may further our
understanding about the important role of progesterone in maintaining a
pregnancy."

Prior studies have found prophylactic progestogen administration to be effective
in reducing the incidence of preterm birth.  Two studies published earlier this
year have renewed researchers' interest in the use of progestogens to prevent
preterm labor and delivery.  Positive results of a trial using weekly
intramuscular injections of synthetic progesterone were published in The New
England Journal of Medicine, and similar encouraging findings of a trial using
daily administration of pharmacy-compounded, progesterone vaginal suppositories
were published in the American Journal of Obstetrics and Gynecology.

More recently, the American College of Obstetricians and Gynecologists' (ACOG)
Committee on Obstetric Practice acknowledged the value of this research.  The
committee issued an opinion stating that progesterone may be used as treatment
to help prevent preterm birth in women with a history of delivering prematurely.
 The opinion encourages additional research on this topic, particularly related
to the ideal method of progesterone delivery.  The March of Dimes commended ACOG
for these guidelines and reaffirmed their call for research to better understand
how women can benefit from progesterone in the prevention of preterm birth.

About Preterm Labor

Preterm delivery is the most vexing problem today in obstetrics.  Despite
intense efforts for prevention, the delivery rate prior to 37 weeks of gestation
increased 12 percent in the United States in 2002.  Approximately 20 percent of
preterm births are the result of a physician's decision to bring about delivery
for maternal and fetal indications.  The remainder of preterm deliveries is
spontaneous, usually following the onset of premature labor or rupture of the
membranes.  The current standard of care to help prevent premature delivery
includes bedrest, intensive prenatal care for high-risk women, and drug therapy,
such as tocolytics, to stop uterine contractions.

About Prochieve 8%

Prochieve 8% utilizes Columbia Laboratories' proprietary Bioadhesive Delivery
System (BDS) to deliver progesterone vaginally in a convenient and easy-to-use
pre-filled, tampon-like applicator. Using a bioadhesive polymer designed to
adhere to the vaginal tissue, Prochieve 8% promotes controlled and sustained
absorption of progesterone and minimizes leakage, a side effect commonly seen
with vaginal suppositories.  As a result, the product does not restrict normal
activities.  Prochieve 8% contains 90 mg of natural progesterone and is a safe
treatment option for women of reproductive age.

The most common side effects of Prochieve 8% include breast enlargement,
constipation, somnolence, nausea, headache, and perineal pain.  Prochieve 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 U.S.-based international pharmaceutical company
dedicated to the development and commercialization 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, please visit
http://www.columbialabs.com/.

This press release contains statements that constitute forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Those statements include statements regarding the intent, belief or current
expectations of the company and its management team.  Prospective investors are
cautioned that any such forward-looking statements are not guarantees of future
performance and involve risks and uncertainties, and that actual results may
differ materially from those projected in the forward-looking statements.  Such
risks and uncertainties include, among other things, the successful completion
of clinical trials, the impact of competitive products and pricing; success in
obtaining acceptance and approval of new products and uses by FDA and
international regulatory agencies; competitive economic and regulatory factors
in the pharmaceutical and healthcare industry, and general economic conditions,
and other risks and uncertainties that may be detailed, from time-to-time, in
Columbia's reports filed with the Securities and Exchange Commission.  The
company undertakes no obligation to publicly update any forward-looking
statements.

   Media Contact:      MCS: Jamie DiGiovanni, [phone], ext 43

   Investor Relations: The Trout Group: Ritu Baral, [phone], ext 25

   Company Contacts:   Columbia Laboratories, Inc.
                       James Apostolakis, Vice Chairman
                       [phone]
                       David Weinberg, Chief Financial Officer
                       [phone]


DATASOURCE: Columbia Laboratories, Inc.



CONTACT:  Media: Jamie DiGiovanni of MCS, [phone], ext. 43, or

Investor Relations: Ritu Baral of The Trout Group, [phone], ext. 25,

both for Columbia Laboratories, Inc.; or James Apostolakis, Vice Chairman,

[phone], or David Weinberg, Chief Financial Officer, [phone],

both of Columbia Laboratories, Inc. 



Web site:  http://www.columbialabs.com/ 

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