Download form 8-k current report - corporate

UNITED STATES
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 (Date of earliest event reported) February 27, 2012
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
(Address of principal
executive offices)
07039
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):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item Regulation FD
7.01 Disclosure
On February 27, 2012, Columbia Laboratories, Inc. (the “Company”), issued a press release entitled,
“Watson Receives Complete Response Letter from FDA for Progesterone Vaginal Gel 8%” (the “Press
Release”). A copy of the Press Release is furnished as Exhibit 99.1 hereto and is incorporated herein by
reference.
The information contained in this Current Report on Form 8-K, including Exhibit 99.1, is being
furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of
1934, as amended, or otherwise subject to the liabilities of Section 18. Furthermore, the information contained
in this Current Report shall not be deemed to be incorporated by reference into any registration statement or
other document filed pursuant to the Securities Act of 1933, as amended.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
99.1* Press Release dated February 27, 2012, entitled “Watson Receives Complete Response
Letter from FDA for Progesterone Vaginal Gel 8%.”
* The information contained in this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and
shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as
amended, or otherwise subject to the liabilities of Section 18. Furthermore, the information contained in this
Current Report shall not be deemed to be incorporated by reference into any registration statement or other
document filed pursuant to the Securities Act of 1933, as amended.
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: February 27, 2012
COLUMBIA LABORATORIES, INC.
By: /S/ Michael McGrane
Senior Vice President, General Counsel
& Secretary
Exhibit Index
Exhibit No.
99.1*
Description
Press Release dated February 27, 2012, entitled “Watson Receives
Complete Response Letter from FDA for Progesterone Vaginal Gel 8%. ”
* The information contained in this Current Report on Form 8-K, including Exhibit 99.1, is being furnished
and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as
amended, or otherwise subject to the liabilities of Section 18. Furthermore, the information contained in
this Current Report shall not be deemed to be incorporated by reference into any registration statement or
other document filed pursuant to the Securities Act of 1933, as amended.
FOR IMMEDIATE RELEASE
Watson Receives Complete Response Letter from FDA for Progesterone Vaginal Gel 8%
PARSIPPANY and LIVINGSTON, NJ- February 27, 2012 - Watson Pharmaceuticals, Inc. (NYSE: WPI) and Columbia
Laboratories, Inc. (Nasdaq: CBRX) today confirmed that, as expected, Watson has received a complete response letter
from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA 22-139) for progesterone
vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine
cervical length in the mid-trimester of pregnancy.
The complete response letter stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of
preterm birth in women with a short uterine cervical length at ≤ 32 6 / 7 weeks gestation (p=0.022) did not meet the level
of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial.
Although not part of the requirements communicated to the sponsor during pre-Phase III meetings, the FDA also raised
the issue of robustness in efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial. In the complete
response letter, FDA stated that additional clinical work would be required to support the approval.
On February 10, 2012, Columbia transferred NDA 22-139 to Watson. Watson now has full rights and regulatory
responsibility for all activities and sponsor obligations relating to this application.
“Watson will work directly with the FDA to address items raised in the complete response letter regarding the
approvability of progresterone vaginal gel 8% for reduction of preterm birth. We have formally requested an end of
review meeting with FDA to determine if a viable path forward can be established for this application ,” said Paul
M. Bisaro, Watson President and CEO. “We believe that there is a significant unmet medical need for a safe and effective
treatment of patients at risk for preterm birth which affects approximately one-in-eight live-born infants in the U.S.”
Data submitted to the FDA in support of approval of NDA 22-139 included results from the PREGNANT study, which
showed that women with a short uterine cervical length as measured by trans-vaginal ultrasound between 19 and <24
weeks of gestation who were treated with progesterone vaginal gel 8% had a significantly lower risk of preterm birth at ≤
32 6 / 7 weeks gestation compared to those who were treated with placebo (p=0.022). This study included women with
and without a prior history of preterm birth. Progesterone vaginal gel 8% was also associated with a significant reduction
in the risk of preterm birth at ≤ 34 6 / 7 weeks gestation (p=0.012).
In the PREGNANT study, the frequency of maternal treatment-emergent adverse events both overall and by individual
event was comparable between the placebo and progesterone vaginal gel treatment groups. The most frequent events in
the progesterone vaginal gel group were expected complications of a high-risk pregnancy and included “premature baby”
(19%), “uterine contractions abnormal” (14%), “premature labor” (7%). “Cervical disorder” (10%), “nausea” (10%),
“headache” (7%), and “vulvo vaginal mycotic infection” (7%) were also reported.
About Watson Pharmaceuticals
Watson Pharmaceuticals, Inc., is a leading integrated global pharmaceutical company. The Company is engaged in the
development, manufacturing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products
focused on Urology and Women's Health. Watson has operations in many of the world's established and growing
international markets.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
About Columbia Laboratories
Columbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to
optimize drug delivery in a controlled, sustained manner. The Company has developed and sold six products for the U.S.
market including CRINONE ® (progesterone gel), for which Columbia receives royalties on annual net sales from
Watson Pharmaceuticals. CRINONE is commercialized outside the U.S. by Merck Serono. Columbia's press releases and
other company information are available online at http://www.columbialabs.com .
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains
forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “intends,” “believes,”
“expects,” “anticipates,” “potential,” “could,” “would,” “should,” and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to 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: success in obtaining timely approval, if any, of a new drug
application (NDA) by the U.S. Food and Drug Administration (FDA) for progesterone vaginal gel 8% for the preterm
birth indication; the timing and level of success of a future product launch, if any; successful development of a
next-generation vaginal progesterone product; difficulties or delays in manufacturing; the availability and pricing of third
party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to
manufacturing facilities, products and/or businesses; changes in the laws and regulations, including Medicaid; the ability
to obtain and enforce patents and other intellectual property rights; the impact of competitive products and pricing; the
timely and successful negotiation of partnerships or other transactions; the strength of the United States dollar relative to
international currencies; 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 Watson's and
Columbia's reports filed with the SEC, including, but not limited to, their Annual Reports on Form 10-K for the year
ended December 31, 2011 and December 31, 2010, respectively, and Columbia's Quarterly Report on Form 10-Q for the
period ended September 30, 2011. Neither Columbia nor Watson undertakes any responsibility to revise or update any
forward-looking statements contained herein, except as expressly required by law.
CRINONE® is a registered trademark of Watson Pharmaceuticals, Inc.
Contacts
For Columbia Laboratories, Inc.
For Watson Pharmaceuticals, Inc.
Investors
Investors
Lawrence A. Gyenes
Patty Eisenhaur
SVP, Chief Financial Officer & Treasurer
VP, Investor Relations and Corp. Comm.
Columbia Laboratories, Inc.
(862) 261-8141
(973) 486-8860
--or--
Media
Seth Lewis
Charlie Mayr
VP, The Trout Group LLC
SVP, Corporate Affairs
(646) 378-2952
(862) 261-8483
Media
Amy Raskopf
President, Raskopf Communications, LLC
(917) 673-5775
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