WOODCLIFF LAKE, N.J., Jan 21, 2005 /PRNewswire-FirstCall via COMTEX/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that the U.S. Food and Drug
Administration (FDA) has informed the Company that it is unable to complete
its review of the Company's Supplemental New Drug Application (sNDA) to market
the Plan B(R) (levonorgestrel) emergency contraceptive Over-The-Counter (OTC)
by the January 21st Prescription Drug User Fee Act (PDUFA) date. The FDA also
indicated to the Company that it is committed to completing its review of the
application in the near future. The Company remains optimistic that the
agency will approve Plan B for OTC sale. Plan B continues to be available to
American consumers by prescription.
The Company's sNDA, if approved, would permit the OTC sale of Plan B
without a prescription for women 16 years of age and older. It would maintain
the prescription status for women age 15 years of age and younger.
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. Effectiveness declines as the interval between intercourse and the start
of treatment increases. Plan B is more effective when taken in the first 24
hours after intercourse. The decline in efficacy from a delay in treatment is
why a broad range of health professionals believe that barriers to more timely
access to Plan B should be removed, including making the product broadly
available without prescription.
Emergency contraception is currently available in 101 countries, 33 of
which do not require a prescription. Emergency contraception is currently
available in some pharmacies without an advance prescription from a physician
or healthcare provider in six U.S. states (Alaska, California, Hawaii, Maine,
New Mexico and Washington).
Plan B was approved by the FDA in 1999 as a safe and effective
prescription only emergency contraceptive for women. Plan B is the first
progestin-only emergency contraceptive. The application seeking over-the-
counter status for Plan B was filed with FDA in 2003. In May 2004 the FDA
issued a Not Approvable Letter offering Barr the option of seeking dual status
that would make the product available over-the-counter for women 16 years of
age and older, and by prescription only for women under the age 15.
Contraindications for Plan B(R)
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. and its subsidiaries are engaged in the
development, manufacture and marketing of generic and proprietary
pharmaceuticals.
Forward-Looking Statements
Except for the historical information contained herein, the statements
made in this press release constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements can be identified
by their use of words such as "expects," "plans," "projects," "will," "may,"
"anticipates," "believes," "should," "intends," "estimates" and other words of
similar meaning. Because such statements inherently involve risks and
uncertainties that cannot be predicted or quantified, actual results may
differ materially from those expressed or implied by such forward-looking
statements depending upon a number of factors affecting the Company's
business. These factors include, among others: 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
outcome of litigation arising from challenging the validity or non-
infringement of patents covering our products; the difficulty of predicting
the timing of FDA approvals; court and FDA decisions on exclusivity periods;
the ability of competitors to extend exclusivity periods for their products;
our ability to complete product development activities in the timeframes and
for the costs we expect; 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 on
products, including the launch of authorized generics; the ability to launch
new products in the timeframes we expect; the availability of raw materials;
the availability of any product we purchase and sell as a distributor; 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 our new enterprise resource planning system; fluctuations in
operating results, including the effects on such results from spending for
research and development, sales and marketing activities and patent challenge
activities; the inherent uncertainty associated with financial projections;
changes in generally accepted accounting principles; and other risks detailed
from time-to-time in our filings with the Securities and Exchange Commission,
including in our Annual Report on Form 10-K for the fiscal year ended June 30,
2004.
The forward-looking statements contained in this press release speak only
as of the date the statement was made. The Company undertakes no obligation
(nor does it intend) to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise, except to the extent required under applicable law.
Carol A. Cox
Barr Pharmaceuticals, Inc.
201-930-3720, ccox@barrlabs.com
