Company Proposes Dual Marketing Status
WOODCLIFF LAKE, N.J., July 22 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today announced that its wholly-owned
subsidiary, Duramed Pharmaceuticals, Inc., has submitted a formal response in
support of its Supplemental New Drug Application (sNDA) for an
Over-the-Counter (OTC) Plan B(R) emergency contraceptive product. The
Company's submission is in response to the Not Approvable Letter that it
received for its application from the U.S. Food and Drug Administration (FDA)
on May 6, 2004. In its formal response to the Not Approvable letter, the
Company has submitted to the FDA information supporting the marketing of Plan
B as a prescription-only product for women 15 years of age and younger and a
nonprescription product for women 16 years of age and older. Duramed currently
markets Plan B as a prescription only product.
"We are pleased to be responding to the FDA with a submission that we
believe will lead to approval of use of Plan B emergency contraceptive as an
over-the-counter product for women 16 and older will maintain the availability
of Plan B as a prescription-only product for women age 15 years and younger,"
said Dr. Carole Ben-Maimon, President and COO of Barr Research. "Under the
regulations, the FDA will have six months to review our application and make a
determination. In the meantime, we remain committed to providing Plan B as a
prescription only product. We are also working to increase awareness among
women and healthcare providers as to the availability of Plan B product and
continue to work to increase the number of states where Plan B is available in
pharmacies without an advance prescription."
Taken within 72 hours of unprotected intercourse, Plan B has been shown to
reduce the risk of pregnancy by 89 percent after a single act of unprotected
sex. Plan B is most effective when taken in the first 24 hours after
intercourse. Effectiveness declines as the interval between intercourse and
the start of treatment increases. The major side effect associated with Plan B
is nausea.
Emergency contraception is currently available in 101 countries, 33 of
which do not require a prescription. Emergency contraception is currently
available in a limited number of pharmacies without an advance prescription
from a physician or healthcare provider in six U.S. states (Alaska,
California, Hawaii, Maine, New Mexico and Washington).
Contraindications for Plan B
Progestin-only contraceptive pills (POPs) are used as a routine method of
birth control over longer periods of time, and are contraindicated in some
conditions. It is not known whether these same conditions apply to the Plan B
regimen consisting of the emergency use of two progestin pills. POPs are not
recommended for use in the following conditions: known or suspected pregnancy;
hypersensitivity to any component of the product; and, undiagnosed abnormal
genital bleeding.
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.
NOTE TO EDITORS: News releases for Barr Pharmaceuticals, Inc. and its
subsidiaries are available free of charge through PR Newswire's News On-Call
site at http://www.prnewswire.com/comp/089750.html. Barr news releases and
corporate information are also available on Barr's website
(http://www.barrlabs.com). Plan B(R) is a registered trademark of Women's
Capital Corporation.
CONTACT:
Carol A. Cox
Barr Pharmaceuticals, Inc.
201-930-3720
ccox@barrlabs.com
