8-K

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.  20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

DATE OF REPORT - September 5, 2006

(Date of Earliest Event Reported)

COLUMBIA LABORATORIES, INC.

(Exact name of registrant as specified in its charter)

Commission File No. 1-10352

Delaware	59-2758596
(State of Incorporation)	(I.R.S. Employer Identification No.)
354 Eisenhower Parkway Livingston, New Jersey	07039
(Address of principal executive offices)	Zip Code

Registrant’s telephone number, including area code: (973) 994-3999

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01.Regulation FD Disclosure.

On September 6, 2006, Robert S. Mills, the president and chief executive officer of Columbia Laboratories, Inc., will present at the Roth Capital Partners 2006 New York Conference in New York City. A copy of the presentation is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

The information furnished herewith pursuant to Item 7.01 of this Current Report and in Exhibit 99.1 hereto shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The furnishing of such information is not an admission as to the materiality of any of the information set forth therein or herein. The information in this Item 7.01 and in Exhibit 99.1 hereto shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01Financial Statements and Exhibits

(d) Exhibits. 

99.1 Presentation by Robert S. Mills, the president and chief executive officer of Columbia Laboratories, Inc., at the Roth Capital Partners 2006 New York Conference on September 6, 2006

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: September 5, 2006
	COLUMBIA LABORATORIES, INC.
	By:	/S/ David L. Weinberg
		David L. Weinberg
		Vice President and Chief Financial Officer

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Exhibit Index

Exhibit No.	Description
99.1	Presentation by Robert S. Mills, the president and chief executive officer of Columbia Laboratories, Inc., at the Roth Capital Partners 2006 New York Conference on September 6, 2006

4

EX-99.1

Columbia Laboratories, Inc.

Robert S. Mills

President and Chief Executive Officer

Roth Capital Partners 2006 New York Conference

September 6, 2006

Except for historical information contained herein, certain statements of Columbia Laboratories, Inc.’s
expectations made in this presentation, including those regarding the timing and potential results of the
Company’s PROCHIEVE^® preterm clinical research program, constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934. Such forward-looking statements involve certain risks and uncertainties. Those statements include
statements regarding the intent, belief or current expectations of Columbia Laboratories and its management
team. 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. Given these uncertainties, investors should not place undue
reliance on these forward-looking statements.  Factors that might cause future results to differ include, but are
not limited to, the following: the successful marketing of PROCHIEVE^® 8% (progesterone gel), PROCHIEVE^®
4% (progesterone gel), and STRIANT ^® (testosterone buccal tablet) in the U.S.; whether  PROCHIEVE ^® is
dispensed to patients of physicians on Serono’s target list of fertility specialists at a rate of less than 10% the
amount of Crinone^® dispensed to those patients as further described in the Company’s annual report on Form
10-K; the timing and size of orders for out-licensed products from our marketing partners; the timely and
successful completion of clinical studies, including the PROCHIEVE ^® 8% study for preventing preterm birth;
success in obtaining acceptance and approval of new products and indications for current products by the
FDA and international regulatory agencies, including acceptance and approval of an indication for preventing
preterm birth for PROCHIEVE^® 8% from the FDA;  the timely and successful development of products; the
impact of competitive products and pricing; 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 obligation to publicly update any forward-looking statements.

Safe Harbor Statement

Under the Private Securities Litigation Reform Act of 1995

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Company Overview

Company:

Public Listing:

Shares Outstanding: Basic

                           Fully Diluted

Headquarters:

Products:

Employees:

Columbia Laboratories, Inc.

NASDAQ: CBRX

49.7 million

61.1 million

Livingston, New Jersey

Promoted (U.S.)

PROCHIEVE^® 8% (progesterone gel) - Infertility & Pregnancy Support

PROCHIEVE^® 4% (progesterone gel) - Secondary Amenorrhea

STRIANT^® (testosterone buccal system) – TRT for Hypogonadism in Men

Partnered

Crinone^® (Ares Serono)

Replens^® (Lil’ Drug Store)

RepHresh^® (Lil’ Drug Store)

Advantage-S^® (Lil’ Drug Store)

STRIANT^® (Europe – Ardana, MiPharm)

52

3

Company Overview

Specialty pharmaceuticals company focused on women's health and
endocrinology markets

Solid commercialized base with both partnered and promoted
products

Sale of batches of partnered products at attractive margins to marketing partners

Additional revenue from promoted products generated by 28-person U.S. sales
organization

Research and development focused on two near-term opportunities

Preventing preterm birth

Preventing and relieving dysmenorrhea

Strong intellectual property portfolio with exclusive patents in:

Progressive Hydration Family (2019)

First Uterine Pass Family (2018)

Progesterone Delivery (2013)

Carbamide Peroxide for Bacterial Vaginosis (2022 Europe; pending in U.S.)

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Management Team

The Liposome Company – VP, General Counsel & Secretary

Novartis Consumer Health – VP, General Counsel & Secretary

Novartis Pharmaceuticals – Associate General Counsel

2002

Michael McGrane

SVP, General Counsel &
Secretary

2003

1997

2001

Joined

Prior Experience

Name / Title

Johnson & Johnson – Senior Director, R&D

George Creasy, M.D., FACOG

VP, Clinical Research

Transmedia Network Inc. – VP & Chief Financial Officer

Key Pharmaceuticals, Inc. – VP of Finance & Treasurer

David Weinberg

VP, Finance & Administration &
Chief Financial Officer

Columbia Laboratories, (formerly) SVP of Operations & COO

Watson Pharmaceuticals – General Manager of Solid Dose
Business & SVP of Manufacturing Operations

Alpharma – VP of Operations

Rhône Poulenc Rorer – 18+ years in various roles

Robert S. Mills

President & Chief Executive
Officer

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Complete Phase III study of PROCHIEVE^® 8% (progesterone gel) for the
prevention of preterm birth, expanding beyond currently-approved indications

Advance lidocaine to prevent and relieve dysmenorrhea to bring new product
to market

Streamline expenses while optimizing return on current product portfolio

Actively pursue strategic partnerships

Ex-U.S. commercialization

U.S. markets outside core focus

Products outside of core focus

Develop additional products using patented Bioadhesive Delivery System
(BDS) technology

GrowthStrategy

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Bioadhesive Delivery System

Technology that uses bioadhesion to
administer medication to patients in a
targeted fashion

Polycarbophil-based, non-
immunogenic (hypo-allergenic)
polymer

Adheres to mucosal surface and
discharged upon normal cell turnover

Oral mucosa for up to 24 hours

Vaginal epithelium for 72+ hours

Enables controlled and sustained drug
release

Able to deliver broad range of
compounds to address numerous
therapeutic areas

Polycarbophil: a
water-swellable,
water-insoluble
polymer with
numerous negative
charges that

permit hydrogen
bonding with the
cell surface

Active entrapped in
the cross-linked
polymer
polycarbophil

Sustained release of
active to tissue

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Partnered Products: Overview

Columbia manufactures and sells batches to partners at attractive
margins

~68% of revenue in 2005

Revenue growth independent of in-house sales organization

Partner manufacturing forecasts

New territory launches

Ardana

18 European Countries

RepHresh^®

Advantage-S^®

Partner

Product

Ares Serono

Worldwide License

Crinone^®

Mipharm

Italy

STRIANT^®

Lil’ Drug Store

Worldwide License

Replens^®

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PROCHIEVE^® 8% (progesterone gel)

Infertility and pregnancy support

PROCHIEVE^® 4% (progesterone gel)

Secondary amenorrhea

STRIANT^® (testosterone buccal system)

Testosterone replacement therapy (TRT)
for hypogonadism in men

OTC products

RepHresh^®

Advantage-S^®

Replens^®

Under 2004 Lil’ Drug Store
professional promotion agreement

Promoted Products: Overview

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Promoted Products: PROCHIEVE^®8%

Natural progesterone in Columbia’s bioadhesive vaginal gel

Self-administered once daily

Only progestin or progesterone FDA-approved for use in infertility

Only progestin or progesterone approved for use in pregnant women

Progesterone supplementation used to optimize clomiphene citrate
cycles as part of Assisted Reproduction Therapy (ART)

Focused promotion to OB/GYNs in the U.S.

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Promoted Products: STRIANT^®

Indications

Hypogonadism in men

Physiologic replacement of testosterone in men

Rapid and sustained delivery of natural testosterone

One dose twice daily maintains consistent physiologic levels of testosterone

Rapid onset and no need for titration

Consistent attainment of normal testosterone levels

Convenience and ease of use compared to other delivery forms (e.g., gel,
patch, injection)

Lower DHT levels versus transdermal gel delivery

No transference issues

Uniform dosing has cost advantage to patients and third-party payors

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Promoted Products: U.S. Strategy

Focus on generating profitability from promoted products with 28-person
sales force

“User-based” selling strategy

Predominant focus on women’s health

Grow baseline women’s health care business

10% prescription growth in 1H 2006

Educate OB/GYNs about PROCHIEVE^® 8% preterm study

Calls on TRT prescribing base to build STRIANT^® prescriptions

Basically flat in 2006, factoring elimination of one-month free promotion program

Revenue components

Modest monthly prescription growth

Supplemental royalties from Serono for Crinone^®

Royalties from Lil’ Drug Store for RepHresh^®

Revenues from manufacturing agreements

Promotion fees from Lil’ Drug Store for OTC products

12

R&D Programs: Overview

Prevention and treatment of Dysmenorrhea

Lidocaine

Vaginal delivery

Funded &
conducted by
Ardana

Third party
study;
providing
product only

II

Enrollment
Completed

III

Prevention of Endometrial Hyperplasia & Endometrial
Cancer associated with estrogen use in menopausal
women

PROCHIEVE^® 4%*

Vaginal Gel

Nocturnal Enuresis in children

Desmopressin*

Buccal Tablet

Fibroid Reduction & Female Sexual Dysfunction

Testosterone*

Vaginal Gel/Tablet

Infertility

Terbutaline*

Vaginal Gel

Prevention of Preterm Birth

PROCHIEVE^® 8%

Vaginal Gel

I

Indication

Product

* Early stage and third party programs that do not impact 2006 R&D budget

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R&D Programs: Preterm Birth

Potential new indication for PROCHIEVE^® 8% (progesterone gel)

~133,000 “at-risk” pregnancies in the U.S. each year, as defined by
previous preterm births

Progestin / progesterone use dramatically reduced incidence of preterm
birth in women with previous preterm birth in 2 major clinical trials

Meis study: 17-OHPC (a synthetic progestin)

DaFonseca study (Brazil): compounded progesterone suppositories

ACOG emphasis on progesterone benefits

October 2003 news release: “Progesterone Recommended in Certain High Risk Pregnancies
to Help Prevent Pre Term Birth”

November 2003 Obstetric Practice Committee: Use of Progesterone to Reduce Preterm Birth

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R&D Programs: Preterm Birth

Potential new indication for PROCHIEVE^® 8% (progesterone gel)

PROCHIEVE^® has the unique position of FDA approval for use during
pregnancy plus a large safety database spanning nine years

Progesterone in PROCHIEVE^® is bioidentical to progesterone made by the
placenta

Unlike synthetic progestins (e.g. 17-OHPC), natural progesterone has a
direct relaxing effect on the uterus

PROCHIEVE^® is approved and clinically proven to promote ovum
implantation and help maintain early pregnancy

No safety signals for miscarriage in nine years of use

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Large-scale, pivotal Phase III study

Double blind, placebo-controlled, randomized at 60+ study centers worldwide

Enrolled patients with the immediate previous preterm delivery at less than 35 weeks gestation

Primary endpoint = percent of preterm birth at less than 32 weeks gestation

Secondary endpoints = percent of preterm birth at less than 35 and 37 weeks gestation

Supplemental endpoint = improvement in fetal and neonate mortality/morbidity at delivery

2 year safety follow-up in children

Goal = expand PROCHIEVE^® 8% label to include new indication: prevention of preterm birth in
women who have had a prior preterm birth

Study timeline:

July 2006 Completed enrollment

669 patients – largest preterm prevention study to date

December 2006Last patient will pass 37 weeks gestation

January 2007Last infant delivered

Q1 2007Present efficacy and preliminary safety data

July 2007Last infant will pass 6 months follow-up

Mid - 2007File with FDA

1H 2008FDA decision on filing

Launch PROCHIEVE^® 8% for preterm birth (if approved)

PROCHIEVE^® Preterm Study

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PROCHIEVE^® 8% vs. 17-OHPC

Prochieve® 8%

Natural progesterone

Self-administered at home
using convenient, pre-filled
tampon like applicator

17-OHPC

Synthetic progestin

Deep intramuscular injection
administered once-weekly in
physician’s office

11 of 306

0 of 70

Miscarriages and
stillbirths on study drug

synthetic progestin

natural progesterone

Drug used

42%

91%

Reduction of preterm
births at <32 weeks

34%

52%

Reduction of preterm
births at <37 weeks

Meis et al

Da Fonseca

Study author

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Dysmenorrhea = recurrent uterine cramping and pain before
and during menses

Affects over 50% of all menstruating women

Accounts for:

600 million lost work hours

Approximately $2 billion in lost productivity annually

Current treatment options inadequate

R&D Programs: Dysmenorrhea

Hypothesis: Vaginally-delivered Lidocaine has the
potential to prevent and relieve dysmenorrhea

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CBRX Clinical Program

Positive results from placebo-controlled 24-patient Pilot Study

Statistically significant results (P <0.05)

…at all time points after vasopressin stimulation for frequency of contractions

…for frequency of contractions, basal pain and cramping based on AUC analysis

Overall reduction in intra-uterine pressure, basal pain & cramping in active group

Completed dosing study in 2Q’05

Next step: complete protocols for 2 new studies

Multiple-dose pharmacokinetics study

Phase II cross-over study

Timeline:

2H 2006Complete study protocols and submit to FDA

Q4 2006Start IRB process for PK study, begin patient enrollment

Q1 2007Start IRB process for cross-over study

1H 2007Begin patient enrollment in cross-over study

1H 2007Announce data from PK study

Mid – 2007Announce data cross-over study

R&D Programs: Dysmenorrhea

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Financial Overview

Operating Expenses

(in millions)

Net Revenues

(in millions)

Six Months Ended June 30,

Six Months Ended June 30,

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Balance Sheet Highlights

As of 6/30/06:

Cash and Equivalents: $22.0M

Total Assets: $29.3M

Additional opportunities to strength the balance sheet:

Additional ex-U.S. partnerships

Divestiture or partnership opportunities

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Solid base business: sale of batches of Partnered Products at
attractive margins to marketing partners

Additional revenues from Promoted Products generated by 28-
person U.S. sales organization

Research and development focused on two near-term
opportunities with significant unmet medical need

PROCHIEVE^® 8% for the prevention of recurrent preterm birth

Lidocaine to prevent and relieve dysmenorrhea

Corporate Highlights

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Columbia Laboratories, Inc.

NASDAQ: CBRX