Bleeding is Rare in IVF Patients Who Become Pregnant When Treated with a Combination of Vaginal Progesterone Gel and Estrogen

* Reuters is not responsible for the content in this press release.

Thu Oct 22, 2009 10:00am EDT

LIVINGSTON, N.J. & ATLANTA--(Business Wire)--
A prospective, multi-center study demonstrated that in IVF (in vitro
fertilization) cycles supplemented with once-daily dosing of Crinone® vaginal
progesterone gel and Estrace® oral estrogen, vaginal bleeding is rare in
patients who become pregnant. Bleeding does occur in approximately one-quarter
of patients who do not become pregnant. These data were presented at the
American Society for Reproductive Medicine (ASRM) annual meeting in Atlanta. 

Vaginal bleeding is reported in some IVF cycles during the luteal phase (the end
of a woman`s menstrual cycle, when progesterone levels are significantly
higher), and can be a major concern for women undergoing infertility treatment.
This study, including 66 patients who became clinically pregnant and 53 patients
who did not conceive, evaluated the effectiveness of the combination of Crinone
with estrogen on luteal phase bleeding. 

In a podium presentation, James P. Toner, MD, PhD, Atlanta Center for
Reproductive Medicine, demonstrated that 36% of patients had spotting or
bleeding associated with egg retrieval. No more than two (5%) of the pregnant
patients bled on any day past egg retrieval. The combination of vaginal
progesterone gel and estrogen appears to reduce the incidence of bleeding in IVF
patients who become pregnant. 

"By treating IVF patients with a combination of Crinone and Estrace, we may
succeed in eliminating bleeding in those who achieve pregnancy and reduce the
level of stress and concern for patients during this stage of their treatment
cycle," stated Dr. Toner. "We are continuing to collect data, including data
from other centers that use either intramuscular progesterone or do not
supplement their Crinone cycles with estradiol, to determine if bleeding rates
are different with these other strategies for luteal support." 

This study was supported by a grant from Columbia Laboratories (Nasdaq: CBRX). 

About Progesterone and Luteal Phase Support

Progesterone is a hormone naturally found in a woman`s body, which creates a
healthy environment in the uterus, where a fertilized egg can implant and grow
into a healthy pregnancy. Most women undergoing infertility treatment need
additional progesterone, to help prepare the uterus for implantation and
development of a fertilized egg. 

Before ovulation, progesterone levels in a woman`s body remain relatively low,
but rise after ovulation, during the luteal phase. The luteal phase is the
latter part of a woman`s menstrual cycle. It begins with the production of
progesterone and ends with either pregnancy or menstruation, when the uterus
sheds its lining. During pregnancy, progesterone helps to maintain the lining of
the uterus, providing necessary nutrients to support and nurture a fertilized
egg. 

About CRINONE® 8%

CRINONE ® 8% was the first FDA-approved natural progesterone for progesterone
supplementation or replacement as part of Assisted Reproductive Technology (ART)
treatments for infertile women with progesterone deficiency, and is the only
once a day treatment. CRINONE 8% is safe for use during pregnancy, and has been
safely used for a decade by tens of thousands of women globally to help sustain
pregnancy in the first trimester. Its unique bioadhesive delivery system
provides controlled and sustained release of progesterone directly where it is
needed. For more information, please visit www.crinoneusa.com. 

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 markets CRINONE 8% (progesterone gel) in the United States for
progesterone supplementation as part of an ART treatment for infertile women
with progesterone deficiency. The Company also markets STRIANT (testosterone
buccal system) for the treatment of hypogonadism in men. The Company`s partners
market CRINONE 8%, STRIANT, and three other products to additional U.S. and
foreign markets. The Company is conducting, in collaboration with the NIH, the
PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study of PROCHIEVE 8% to
reduce the risk of preterm birth in women with a short cervix at mid-pregnancy.
For more information, please visit www.columbialabs.com. 

Safe Harbor Statement Under the Private Securities Litigation Reform Act of
1995: This press release may contain forward-looking statements about Columbia
Laboratories, Inc.`s expectations regarding the Company`s strategic direction,
prospects and future results, and clinical research programs, which statements
are indicated by the words "will," "plan," "expect" and similar expressions.
Such forward-looking statements involve certain risks and uncertainties; actual
results may differ materially from those projected in the forward-looking
statements. Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date on which they are
made. Factors that might cause future results to differ include, but are not
limited to, the following: the successful marketing of CRINONE 8% (progesterone
gel) and STRIANT (testosterone buccal system) in the U.S.; the successful
marketing of CRINONE 8% by Merck Serono, and RepHresh and Replens by Lil` Drug
Store Products, Inc; the timely and successful development of PROCHIEVE 8% to
reduce the risk of preterm birth in women with a short cervix in mid-pregnancy;
the timely and successful completion of the ongoing Phase III PREGNANT
(PROCHIEVE Extending GestatioN A New Therapy) Study of PROCHIEVE 8% in short
cervix patients; success in obtaining acceptance and approval of new products
and new indications for current products by the FDA and international regulatory
agencies; our ability to obtain financing in order to fund our operations and
repay our debt as it comes due; the impact of competitive products and pricing;
the strength of the U.S. dollar relative to international currencies,
particularly the Euro; competitive economic and regulatory factors in the
pharmaceutical and healthcare industry; 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. Columbia Laboratories
undertakes no obligationto updateany forward-looking statements.

PROCHIEVE®, CRINONE® and STRIANT® are registered trademarks of Columbia
Laboratories, Inc.

Investors:
Columbia Laboratories, Inc.
Lawrence A. Gyenes, 973-486-8860
Senior Vice President,CFO & Treasurer
or
Rx Communications Group, LLC
Melody A. Carey, 917-322-2571
or
Media:
Cella Communications
Gina Cella, 781-334-4692
ginacella@comcast.net

Copyright Business Wire 2009

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