UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-1004
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): AUGUST 20, 1999
COLUMBIA LABORATORIES, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 1-10352 59-2758596
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(State or other jurisdiction- (Commission (IRS Employer
of incorporation) File Number) Identification Number)
2875 NORTHEAST 191 STREET, SUITE 400, AVENTURA, FLORIDA 33180
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(Address of principal executive offices) (Zip Code)
(305) 933-6089
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(Registrant's telephone number, including area code)
37965.0012
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Item 5. Other Events
On August 23, 1999, Columbia Laboratories, Inc. (the "Registrant")
plans to begin publication of a bi-monthly stockholders newsletter in order to
keep its stockholders updated on its latest product developments; its position
within evolving markets; market penetration; new launches of existing product
lines; and changes in regulations or the market environment which could alter
the Registrant's position in the market.
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Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
(c) Exhibits
Exhibit Description
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99.1 Columbia Laboratories, Inc.'s August, 1999 newsletter.
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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.
COLUMBIA LABORATORIES, INC.
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(Registrant)
By: /s/ David L. Weinberg
---------------------------------
David L. Weinberg
Chief Financial Officer
Date: August 20, 1999
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EXHIBIT INDEX
Exhibit Description
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99.1 Columbia Laboratories, Inc.'s August, 1999 newsletter.
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EXHIBIT 99.1
Columbia Laboratories is initiating this bimonthly newsletter to keep its
stockholders updated on the latest product developments and their position
within the evolving markets. We will also keep you current on market penetration
and new launches of our existing product line and inform you of changes in
regulations or market environment that can alter Columbia's position.
August, 1999
ARES-SERONO TO RE-LAUNCH CRINONE(R) 8% (PROGESTERONE GEL) IN SEPTEMBER AT THE
ASRM
Ares-Serono, the world leader in reproductive health, will commence its
worldwide re-launch of Crinone 8% at the American Society of Reproductive
Medicine (ASRM) Annual Meeting in Toronto, September 25 - 30, 1999. During this
meeting an interim analysis of a study conducted in more than 1,250 women using
Crinone 8% as part of an IVF procedure will be presented. This interim analysis
of one of the largest IVF studies ever conducted, suggests that clinical
pregnancy rates with Crinone 8% are significantly higher when compared to
historical data from these 16 participating U.S. centers. Prior to using Crinone
8% the vast majority of these centers used intramuscular (IM) progesterone. The
interim analysis suggests there is no reason to subject women to painful daily
deep intramuscular injections of progesterone when simple vaginal applications
of Crinone 8% gel will prepare the endometrium (the lining of the uterus) for
embryo implantation and maintain pregnancy.
In the same multi-center study nearly 400 women undergoing Intrauterine
Insemination (IUI) procedures were evaluated. Clinical pregnancy rates in these
women were well above norm demonstrating the benefits of using Crinone 8% to
support the luteal phase in IUI procedures. (This data will also be presented at
the ASRM in Toronto in September 1999). Approximately, 500,000 IUI procedures
are performed annually in the U.S. alone, appreciably expanding the market
opportunity for Crinone 8%.
Ares-Serono will begin the launch of Crinone 8% in many new countries in Europe
and South America during the fourth quarter, 1999. They will also significantly
step-up the marketing effort in countries where Crinone 8% has already been
launched, notably the United States, Germany, Italy and the UK.
MIPHARM TO LAUNCH MIPHIL(TM) IN ITALY IN OCTOBER, 1999
Bacterial vaginosis (BV) is the most common vaginal disorder in women of
reproductive age affecting 15 to 20% of women. Many patients complain of vaginal
discharge and a foul amine (fishy) odor. The odor is caused by amines produced
by various species of bacteria which replace the dominant member of the normal
vaginal flora, lactobacilli. A vaginal pH above 5 favors the growth of these
microorganisms over lactobacilli and volatilizes the amines to produce the
unpleasant odor. This odor is particularly prominent for 24 hours after
unprotected intercourse because of semen's high pH (7.8- 8.2) and buffering
capacity.
Miphil(TM) vaginal gel developed by Columbia and licensed to Mipharm for
Southern Europe is a unique product that reduces vaginal pH for 72 hours or more
and eliminates the odor associated with BV. Odor is eliminated by Miphil's
pH-lowering action as of the first administration. When pH is maintained below
5, there is an increased likelihood that the vagina will be recolonized by the
normal vaginal constituent, lactobacilli. The long lasting pH effect of Miphil
is made possible by bioadhesion, a delivery system that allows the product to
adhere to vaginal epithelial cells and stay in place until they turn over,
approximately 3 to 5 days. Miphil contains no antimicrobial agent and does not
induce the side effects often encountered with oral therapies used to eradicate
recurrent BV. Miphil's key ingredient is
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polycarbophil, a patented bioadhesive polymer used in medical and healthcare
products utilized by several hundred thousand women worldwide. Polycarbophil,
which is also the base of the progesterone vaginal gel (Crinone(R)) approved for
use in pregnant women worldwide, has a high buffering capacity that maintains
the vaginal pH in the physiologic range 4-5. In 1999, Columbia received a new
patent for the pH action of polycarbophil, a very large molecule that is neither
absorbed nor immunogenic.
The launch of Miphil in Italy will provide marketing insight, thereby helping
facilitate its launch by additional partners in other European countries and by
Columbia in the United States, next year. Miphil will compete against vaginal
douches which are used by nearly 30% of women in the United States. Douching is
frowned upon by most gynecologists because it has a negative impact on the
natural vaginal flora. Miphil on the other hand, reduces pH and favors a normal
flora.
CHRONODYNE(TM) (TERBUTALINE GEL) TO ENTER PHASE III STUDIES
Menstrual cramping is a problem afflicting more than 30% of women of
reproductive age, with more than 17 million sufferers in the U.S. and over 20
million in Europe. Most women experience cramping just prior to and during the
first few days of menses. The utero-relaxant effects of terbutaline and other ?2
agonists have been well documented. Use of terbutaline results in decreased
myometrial (uterine muscle) activity thereby alleviating uterine cramping.
Terbutaline simultaneously increases local uterine blood flow in women with
menstrual cramping. However, ?-agonists such as terbutaline have not previously
been used to prevent or treat the uterine cramping due to an unacceptable level
of adverse effects, primarily tachycardia (rapid heart rate) and tremors.
Columbia Laboratories has developed Chronodyne, a vaginal terbutaline gel, for
use in menstrual cramping. Columbia's patented bioadhesive delivery system
ensures the controlled and prolonged release of terbutaline to the uterus. The
vaginal route utilizing Columbia's patented system preferentially transports
terbutaline directly from the vagina to the uterus, thereupon ensuring
therapeutic uterine concentrations while avoiding high serum levels commonly
associated with side effects. Early studies have demonstrated that Chronodyne
does not increase heart rate or cause tremors.
Currently, no other product effectively addresses the underlying cause of
menstrual (uterine) cramping. Women use prescription and over-the-counter
analgesics such as Tylenol(R) and Advil(R) to counter the pain. At best these
agents diminish the discomfort but do Not alleviate all the symptoms. Chronodyne
begun at the first sign of menstrual cramping, usually one to two days before
menses, can prevent uterine contractions thus eliminating the problem. No other
product can produce this result without concurrently creating severe adverse
effects. The market opportunity is enormous if Chronodyne performs well in
clinical trials. The development program for Chronodyne continues to be on
target with an expected approval and launch date in the 3rd quarter of 2001.
Timing of development plan:
o Completion of Phase II - 4th quarter, 1999
o Beginning of Phase III - 4th quarter, 1999
o Completion of Phase III - 3rd quarter, 2000
o NDA and UK (Multi-state procedure) registration to be filed - 4th
quarter, 2000
o Approval and launch expected in the US and Europe - 3rd quarter 2001.
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TESTOSTERONE BIOADHESIVE BUCCAL TABLETS - NEW TECHNOLOGY THAT COULD SPAWN A
GENERATION OF PATENTED THERAPEUTICS
Statistics show that one million men in Europe and the United States suffer from
hypogonadism, characterized by a deficiency or absence of endogenous
testosterone production. Columbia has developed a testosterone bioadhesive
tablet (new patent pending) which adheres to the buccal mucosa for more than 12
hours. The tablet completely replaces the physiologic levels of testosterone
produced by men, contrasting with commonly used large transdermal patches which
produce sub-physiologic levels by only delivering 5 mg per day. The new
bioadhesive buccal tablet is only 9 mm in diameter and insensible after being
inserted into the mouth. Phase III studies for the treatment of hypogonadal men
are planned for 2000 and an NDA submission is planned early 2001.
Columbia is also developing the testosterone tablet for treatment of andropause
in men. Like the failure of the ovaries to produce estrogen in menopausal women,
andropause is characterized by a failure of the testis to produce sufficient
testosterone. Andropause has the same impact on men as menopause on women,
increasing risk of cardiovascular disease, Alzheimer's disease and osteoporosis.
Columbia is now exploring ways in which it can take advantage of this large
market opportunity.
This newsletter contains statements which 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 note 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, possible delays in the marketing of
Crinone 8% and Miphil, possible delays in the development of Chronodyne and
testosterone biodadhesive buccal tablets, competitive, economic, and regulatory
factors in the pharmaceutical and health care 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.
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