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Couples Health: wire services |
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On the
Rag
4-Times a Year?
Yup! Now it
IS Possible!
(&
Gentlemen, that equates to 66% fewer opportunities for an
'Oops!")
LA JOLLA, CA: 09/09/2003 -- On
September 11th, the Association of Reproductive Health
Professionals' (ARHP) will sponsor a timely presentation on
extended regimen contraception -- the management of menstrual
cycles by skipping the hormone free week in a birth control
pill. The FDA approved the first extended regimen
contraceptive, marketed under the name
Seasonale, on
September 5th. ARHP will also be releasing preliminary data
from a national survey entitled Women's Attitudes, Beliefs,
and Perceptions About Menstrual Periods, which features new
insights into women's acceptance and experience with
menstruation.
"Extended regimen contraceptives give women another
reproductive health choice-when and whether to experience
menstrual bleeding," says Andrew M. Kaunitz, MD, who will be
conducting the session and is a professor and assistant
chairman of obstetrics and gynecology at the University of
Florida, Health Science Center in Jacksonville. "For years
clinicians on an individualized basis have safely and
effectively prescribed oral contraceptives in such a way as to
reduce the frequency of menstrual cycles. The convenience of
the first pill FDA-approved for extended use (Seasonale) will
increase acceptance of this option."
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Barr Laboratories, Inc. (NYSE:BRL)
September 8, 2003 announced that the U.S. Food and
Drug Administration (FDA) has approved the Company's
SEASONALE(R) (levonorgestrel and ethinyl estradiol)
0.15 mg/0.03 mg tablets, an extended-cycle oral
contraceptive for the prevention of pregnancy.
SEASONALE, the first and only FDA-approved
extended-cycle oral contraceptive, will be available
by prescription to women at the end of October 2003.
TOP
The SEASONALE regimen is designed to reduce the number
of periods from 13 to 4 per year. SEASONALE is a
91-day regimen taken daily as 84 active tablets of
0.15 mg of levonorgestrel/0.03 mg of ethinyl estradiol,
followed by 7 inactive tablets. By contrast, oral
contraceptive products currently available in the
United States are based on a 28-day regimen.
"The SEASONALE approval represents several 'firsts'
for Barr. It is our first internally developed New
Drug Application (NDA) product to gain FDA approval
and we believe that it represents a significant
advance in oral contraception," said Bruce L. Downey,
Barr's Chairman and CEO.
TOP |
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Safe Harbor Statement:
To the extent that any
statements made in this report contain information
that is not historical, these statements are
essentially forward-looking. These statements are
subject to risks and uncertainties that cannot be
predicted or quantified and, consequently, actual
results may differ materially from those expressed or
implied by such forward-looking statements. Such risks
and uncertainties include: the difficulty in
predicting the timing and outcome of legal
proceedings, including those relating to patent
challenge settlements and patent infringement cases;
the difficulty of predicting the timing of U.S. Food
and Drug Administration, or FDA, approvals; court and
FDA decisions on exclusivity periods; the ability of
competitors to extend exclusivity periods past initial
patent terms; market and customer acceptance and
demand for our pharmaceutical products; reimbursement
policies of third party payors; our ability to market
our proprietary products; the successful integration
of acquired businesses and products into our
operations; the use of estimates in the preparation of
our financial statements; the impact of competitive
products and pricing; the ability to develop and
launch new products on a timely basis; the
availability of raw materials; availability of any
product we purchase and sell as a distributor; the
regulatory
environment; fluctuations in operating results,
including spending for research and development, sales
and marketing and patent challenge activities; the
outcome of the litigation between Wyeth and Natural
Biologics, and our resulting ability to have access to
the principal raw material for our conjugated
estrogens product produced by Natural Biologics and
have our loans to Natural Biologics repaid in full;
and, other risks detailed from time-to-time in our
filings with the Securities and Exchange Commission,
or SEC. Forward looking statements can be identified
by the use of words such as "expects," "plans,"
"will," "may," "anticipates," "believes," "should,"
"intends," "estimates," and other words of similar
meaning. These statements are subject to risks and
uncertainties that cannot be predicted or quantified
and, consequently, actual results may differ
materially from those expressed or implied by such
forward-looking statements. The Company undertakes no
obligation to publicly update any forward-looking
statements.
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"The development of our SEASONALE product underscores Barr's
commitment to women's health care, especially in the area of
oral contraception. It is the first of what we believe will be
several additional new drug applications for women's
healthcare products over the next several years." SEASONALE
was developed by Barr under an agreement with Eastern Virginia
Medical School (EVMS)."With today's approval of SEASONALE,
women have a new choice when deciding on oral contraception,"
said Carole S. Ben-Maimon, M.D., President and COO of Barr
Research. "For those women who prefer the convenience of fewer
periods, SEASONALE offers a safe and effective alternative to
the traditional 28-day oral contraceptive regimen."
TOP
The Company's 250-person Duramed
Pharmaceuticals, Inc. women's healthcare sales force will
promote the SEASONALE oral contraceptive directly to
physicians and healthcare providers. Duramed is a wholly owned
subsidiary of Barr Laboratories, Inc., resulting from the 2001
merger of Barr and Duramed. The Duramed sales force currently
promotes Cenestin(R) (Synthetic Conjugated Estrogens, A).
Clinical Data
The clinical data supporting FDA approval of the SEASONALE(R)
(levonorgestrel and ethinyl estradiol) 0.15 mg/0.03 mg tablets
product resulted from a randomized, open-label, multi-center
trial that ended in March 2002 and an extension to that trial.
In the trials, SEASONALE was found to prevent pregnancy and
had a comparable safety profile to a more traditional oral
contraceptive.
In the trial, the most reported adverse events were
nasopharyngitis, headache and intermenstrual bleeding or
spotting.
SEASONALE has been formulated using well-established
components, long recognized as safe and effective when used in
a 28-day regimen. SEASONALE offers 4 periods per year as
compared to 13 per year with traditional oral contraceptives.
When prescribing SEASONALE, the convenience of fewer planned
menses (4 per year instead of 13 per year) should be weighed
against the inconvenience of increased intermenstrual bleeding
and/or spotting. A recently published Roper study found that
when given the choice, nearly two-thirds of women would be
interested in reducing their number of periods to 4 times per
year (1). TOP
Important Information About Oral
Contraceptives
It is estimated that more than 16 million
women currently take oral contraceptives in the United States.
Oral contraceptives are not for every woman. Serious risks
associated with birth control pills that can be life
threatening include blood clots, stroke and heart attack.
These risks are increased in women who smoke cigarettes,
especially women over 35. Women who use oral contraceptives
should not smoke. Some women should not use birth control
pills, including women who have had a heart attack, stroke,
blood clots, certain cancers or liver diseases, unexplained
vaginal bleeding, and those who are or may be pregnant. Birth
control pills do not protect against HIV infection (AIDS) or
other sexually transmitted diseases. Use of SEASONALE provides
women with more hormonal exposure on a yearly basis than
conventional monthly oral contraceptives containing similar
strength synthetic estrogens and progestins (an additional 9
weeks per year). While this added exposure may pose an
additional risk of thrombotic and thromboembolic disease,
studies to date with SEASONALE have not suggested an increased
risk of these disorders. Barr Laboratories, Inc. is engaged in
the development, manufacture and marketing of generic and
proprietary pharmaceuticals.
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