WOODCLIFF LAKE, N.J., Sept. 7 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today announced that it has exercised its
option to make a one-time royalty payment of $19 million to Eastern Virginia
Medical School (EVMS) related to Barr's exclusive research and license
agreement for the SEASONALE(R) extended-cycle oral contraceptive. Under terms
of the licensing agreement, Barr had the option of paying a perpetual royalty
based on a percentage of net profits, or exercising its right to make the one-
time payment prior to the first anniversary of the approval date of the
SEASONALE product by FDA.
"Since the launch, more than 260,000 prescriptions have been filled for
SEASONALE, and we anticipate continued strong growth for this exciting
contraceptive option. We also continue to work on other extended-cycle oral
contraceptives that will broaden this product franchise," said Bruce L.
Downey, Chairman and Chief Executive Officer. "By exercising our option to
make this one-time royalty payment, we have satisfied all future royalty
obligations to EVMS and provided them with a substantial return on the
research conducted at their outstanding institution."
The $19 million one-time royalty payment will initially be capitalized,
and ultimately expensed over the estimated lives of the products marketed by
Barr under the license agreement.
Barr launched the SEASONALE extended-cycle oral contraceptive in November
2003 to healthcare providers following FDA approval of the product for the
prevention of pregnancy. SEASONALE was developed under a research and license
agreement with EVMS. At the time of FDA approval, SEASONALE was granted a
three-year New Product Exclusivity that expires on September 5, 2006. The
patent covering SEASONALE expires in 2017.
SEASONALE, the first and only FDA-approved extended-cycle oral
contraceptive indicated for the prevention of pregnancy, 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 and is designed to reduce
the number of periods from 13 to 4 per year.
Barr currently details the product to physicians and other healthcare
providers with its 250-person Duramed Pharmaceuticals, Inc. Women's Healthcare
Sales Force. Duramed is a subsidiary of Barr Pharmaceuticals, Inc.
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 as well as minor side effects have been reported with the use
of hormonal contraceptives. Serious risks include blood clots, stroke, and
heart attack. Cigarette smoking increases the risk of serious cardiovascular
side effects, especially in women over 35 years. Oral contraceptives do not
protect against HIV infection (AIDS) and 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. The convenience of fewer menses (4 vs. 13
per year) should be weighed against the inconvenience of increased
intermenstrual bleeding/spotting.
Eastern Virginia Medical School is located in Norfolk, Virginia. Founded
in 1973, its Department of Obstetrics and Gynecology includes the Jones
Institute for Reproductive Medicine, which was responsible for the birth of
America's first baby conceived through in-vitro fertilization and the creation
of SEASONALE technology.
Barr Pharmaceuticals, Inc., a holding company that operates through its
principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals,
Inc., is engaged in the development, manufacture and marketing of generic and
proprietary pharmaceuticals.
Forward-Looking Statements
This press release contains a number of forward-looking statements. To the
extent that any statements made in this press release contain information that
is not historical, these statements are essentially forward-looking. Forward-
looking statements can be identified by their 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. Such risks and uncertainties
include: the difficulty in predicting the timing and outcome of legal
proceedings, including patent-related matters such as 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 for their products; the success of our product development
activities; market and customer acceptance and demand for our pharmaceutical
products; our dependence on revenues from significant customers; reimbursement
policies of third party payors; our dependence on revenues from significant
products; 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; the
availability of any product we purchase and sell as a distributor; our mix of
product sales between manufactured products, which typically have higher
margins, and distributed products, which typically have lower margins, during
any given period; the regulatory environment; our exposure to product
liability and other lawsuits and contingencies; the increasing cost of
insurance and the availability of product liability insurance coverage; our
timely and successful completion of strategic initiatives, including
integrating companies and products we acquire and implementing new enterprise
resource planning systems; fluctuations in operating results, including the
effects on such results from spending for research and development, sales and
marketing activities and patent challenge activities; and other risks detailed
from time-to-time in our filings with the Securities and Exchange Commission.
SOURCE Barr Pharmaceuticals, Inc.
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Related links:
http://www.barrlabs.com
Company News On-Call:
http://www.prnewswire.com/comp/089750.html
CONTACT:
Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com
NOTE TO EDITORS: Barr news releases and corporate information are
also available on Barr's website (http://www.barrlabs.com). For
complete indications, warnings and contraindications, contact
Barr Laboratories' Professional Services Department at 1-800-Barr
Lab. Barr Laboratories, Inc. is the exclusive licensee of
SEASONALE(R), a registered trademark.
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