UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-1004
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 159(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 2, 1999
COLUMBIA LABORATORIES, INC.
(Exact name of registrant as specified in its character)
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<S> <C> <C>
DELAWARE 1-10352 59-2758596
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(State or other jurisdiction- (Commission (IRS Employer
of incorporation) File Number) Identification Number)
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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)
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Item 5. Other Events
On November 3, 1999, Columbia Laboratories, Inc. (the
"Registrant") plans to disseminate its 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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99.2 Columbia Laboratories, Inc.'s November, 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
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David L. Weinberg
Chief Financial Officer
Date: November 2, 1999
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EXHIBIT INDEX
EXHIBIT DESCRIPTION
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99.2 Columbia Laboratories, Inc.'s November, 1999 newsletter.
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EXHIBIT 99.2
COLUMBIA LABORATORIES BI-MONTHLY STOCKHOLDER NEWSLETTER
November, 1999
ARES-SERONO (TK:AREB) RE-LAUNCHES CRINONE /registered trademark/ 8% at the
Conjoint Annual Meeting of the American Society foR Reproductive Medicine and
the Canadian Fertility and Andrology Society held in Toronto from September 27th
to 30th.
The highlight of the launch was the presentation of the positive interim results
of the ongoing treatment protocol study of Crinone /registered trademark/ 8%
(progesterone gel) as progesterone supplementation in women undergoing AssisteD
Reproductive Technologies (ART). The study demonstrated that Crinone has
exceptional clinical pregnancy rates and is preferred by women. The 1251 women
between the ages of 21 and 47 (mean 37 years) involved in the 16 centers
analyzed achieved a clinical pregnancy rate of 35.2 percent. Crinone is
currently being studied in a clinical trial in the US involving over 2,000 women
at 23 infertility treatment centers. This interim analysis includes the
experiences of 1,251 women in 16 centers undergoing in vitro fertilization
during 1997-98.
This was statistically significantly higher (p /less than/ 0.002) than the
clinical pregnancy rate (30.6%) reported to the official organization, SART for
women under age 40 in the same 16 centers in the latest published report, 1996.
Moreover, Crinone's unique administration allows women the convenience and
benefits of progesterone therapy without undergoing painful intramuscular
injections.
As part of the trial, patients were asked to describe their experiences with
progesterone therapies. Participants reported that they preferred Crinone to
other forms of progesterone treatments, specifically intramuscular injections
and suppositories. Of patients who had previously undergone a different form of
progesterone treatment, 91 percent of patients (n = 420) preferred Crinone to
intramuscular injections and 90 percent of patients (n = 463) preferred Crinone
to suppositories. In describing their overall experience using Crinone, 94.4
percent of patients (n = 1,018) found Crinone easy to administer, 94.9 percent
(n = 1,016) reported no pain with Crinone and 74.6 percent (n = 1,018)
considered Crinone not to be messy.
Further, of 590 patients receiving Crinone in combination with follicle
stimulating hormone (FSH), 34.9 percent achieved a clinical pregnancy as
compared to 25.7 percent of 210 patients receiving Crinone in combination with
human menopausal gonadotropin (hMG).
Since the 1st of October the Ares-Serono has been actively marketing Crinone in
the United States and we believe we will begin to see the results of their
intensive efforts over the next few months.
ARES-SERONO DISCLOSES THAT IT PURCHASED THE LICENSE AND DISTRIBUTION RIGHTS TO
CRINONE FROM AMERICAN HOME PRODUCTS FOR $68 MILLION - Under the terms of the
agreement, Ares-Serono assumes the same financial obligations to Columbia. For
example, Columbia continues to receive approximately 30% of net sales for
providing the finished product. Ares-Serono will also make additional payments
to Columbia and American Home Products when certain milestones are achieved.
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FOUR (4) NEW COUNTRY APPROVALS HAVE BEEN GRANTED THIS MONTH FOR CRINONE -
Norway, Sweden, Canada and Hong-Kong. Within six months we expect Ares-Serono to
be selling Crinone in more than 20 countries.
COLUMBIA LABORATORIES ENGAGES RYAN, BECK & CO. AS EXCLUSIVE ADVISOR TO DIVEST
ITS OVER-THE-COUNTER BUSINESS - The funds generated from the divestiture will be
used to speed the development of Columbia's innovative prescription products
while simultaneously reducing overhead. Columbia will concentrate on its
extensive pipeline of prescription products, including Chronodyne /trademark/
(terbutaline gel) for the treatment of dysmenorrhea, a testosterone tablet for
physiologic replacement in men and a unique vaginal testosterone formulation for
menopausal women. This transaction will have three important benefits for
Columbia Laboratories. First, it will focus our attention on the major
opportunities for the company, including Chronodyne /trademark/ (terbutaline
gel) and our testosterone buccal tablet for men. Both products should enter
Phase III early next year and have significant market potential. Second, this
transaction will ensure that we have the resources to bring these products to
market in a timely fashion. Third, it will simultaneously allow us to reduce
corporate overhead and expenses.
NEW CLINICAL DATA SUPPORTS THE SUPERIORITY OF REPHRESH /trademark/ (MIPHIL
/trademark/) OVER ACID DOUCHES IN REDUCING VAGINAL PH - A randomized single
center parallel design study comparing Miphil /trademark/ and the vaginal
douche, Lactacid /registered trademark/ in 30 women with suspected BV was
recently completed. The women were either administered 2.5 g of Miphil
/trademark/ or the vaginal douche Lactacid /registered trademark/ twice a week
for six (6) weeks. The primary objective of the study was to determine the
effect of Miphil /trademark/ and the vaginal douche on vaginal pH. The efficacy
of both treatments was measured at baseline three (3) and six (6) weeks by using
a pH meter to measure the pH in the lateral vaginal fornix.
At the end of six weeks there was a statistically and clinically significant
reduction in pH in the 15 women receiving Miphil /trademark/ from a mean of 5.4
to 4.6. There was a slight, but clinically insignificant reduction of vaginal pH
in the 15 women using the vaginal douche Lactacid /registered trademark/ from
5.6 to 5.3. The difference between the reduction in pH between Miphil
/trademark/ and Lactacid /registered trademark/ was statistically significant (p
/less than/0.04 two way ANOVA test)
Effects of MipHil /trademark/ (RepHresh /trademark/) and Vaginal
Douche on vaginal pH
GRAPHIC OMITTED
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Bacterial vaginosis (BV) is the most common vaginal disorder in women,
afflicting 15 to 20% of women of reproductive age. Many women complain of
vaginal discharge and a foul amine (fishy) odor. The cause of the odor is the
production of amines by various species of bacteria that replace lactobacilli as
the dominant members of the vaginal flora. A vaginal pH above 5 favors the
growth of these microorganisms over lactobacilli and volatizes the amines they
produce. The odor is particularly prominent for 24 hours after unprotected
intercourse because of the high pH (7.8- 8.2) and buffering capacity of semen.
In the United States discharge and foul smelling odor send millions of women to
a physician's office each year in search of relief. An even larger number,
estimated to be 30% of all adult American women, use douches that they purchase
without a prescription. The idea of washing out the foul smelling discharge with
an acid douche has a simplistic appeal. Medically, douching is frowned upon as
studies have reported an association between douching and pelvic inflammatory
disease (PID), ectopic pregnancy, tubal infertility and reduced fertility.
REPHRESH /trademark/ vaginal gel is a unique product that reduces vaginal pH for
72 hours or more and eliminates the odor associated with bacterial vaginosis
(BV). The pH-lowering action of REPHRESH /trademark/ often eliminates odor from
the very first dose. When pH is maintained below 5, there is an also an
increased likelihood that the vagina will be recolonized by the normal vaginal
constituent, lactobacilli. The long lasting pH effect of REPHRESH /trademark/ 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. REPHRESH /trademark/ contains no antimicrobial agent
and does not induce the side effects often encountered with oral therapies used
to eradicate recurrent BV. The key ingredient in REPHRESH /trademark/ is
polycarbophil, a patented bioadhesive polymer used in medical and healthcare
products by several hundred thousand women worldwide. Polycarbophil, which is
also the base of the progesterone vaginal gel (Crinone /registered trademark/ )
has been approved for use even in pregnant women. REPHRESH /trademark/ 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.
CHRONODYNE /trademark/ (TERBUTALINE GEL) PHASE II STUDY COMPLETED - PHASE III
STUDIES TO COMMENCE SHORTLY. - Uterine 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. It is the leading cause of absenteeism
from work in both the United States and Europe. Most women experience cramping
just prior to and during the first few days of menses. The utero-relaxant
effects of terbutaline and other (beta)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, (beta)-agonists, such as
terbutaline, have not been used to prevent or treat the uterine cramping due to
an unacceptable level of adverse effects, primarily tachycardia (rapid heart
rate) and tremors.
Currently, no other product effectively addresses the underlying cause of
menstrual (uterine) cramping. Women use prescription and over-the-counter
analgesics such as
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Tylenol /registered trademark/ and Advil /registered trademark/ to counter the
symptoms usually associated with cramping, including pain. At best these agents
diminish the discomfort but do not alleviate all the symptoms.
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 delivery of terbutaline to the uterus. The
vaginal route utilizing Columbia's patented system preferentially transports
terbutaline directly from the vagina to the uterus, thereby, providing
therapeutic uterine concentrations while avoiding high serum levels commonly
associated with side effects. Early studies have demonstrated that Chronodyne
/trademark/ does not cause significant increases in heart rate or cause tremors.
NEW TRIALS ON TESTOSTERONE BUCCAL TABLETS FOR MEN TO BEGIN IN NOVEMBER - New
trials are being conducted to delineate the complete pharmacokinetic profile of
this unique product. Upon completion of the pharmacokinetic trials, Phase III
studies will begin early next year. This development program remains on target
for a year 2001 submission for approval.
This release 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, 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.
