Company Will Launch Product Under Claravis(TM) Trademark
POMONA, N.Y., April 11 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc.
(NYSE: BRL) today announced that the U.S. Food & Drug Administration (FDA) has
approved its application to manufacture and market a generic version of Roche
Pharmaceutical's Accutane(R) Capsules, 10 mg, 20 mg and 40 mg.
The Company plans to market the product as a generic under the trademark
name Claravis(TM). The Company plans to launch the product in May.
"With the approval of Claravis, the Company demonstrates our ability to
successfully develop complex generic products," said Bruce L. Downey, Barr's
Chairman and CEO. "We also have established an extensive educational program,
including dissemination of educational materials to physicians and
pharmacists, a patient and physician education and registry program and
establishment of a toll free number and website for both physicians and
patients who may have questions regarding use of the product."
The Company plans to promote the product to dermatologists using its sales
force that currently markets Trexall(TM) (Methotrexate Tablets, USP). Barr
has implemented a comprehensive education, risk assessment and management
program for patients, pharmacists and physicians that includes, but is not
limited to, a toll free registration program for prescriber registration and
education, a website for healthcare professionals and patients, patient
education materials designed to inform patients about the risks associated
with use of Claravis, and a pregnancy prevention program. The risk management
aspects of the program include pregnancy testing and avoidance, patient
awareness and consent to avoid pregnancy, and aware ness of psychoactive
disorders prior to and during therapy.
Claravis is indicated for the treatment of severe recalcitrant nodular
acne. Because of the significant adverse effects associated with its use,
Claravis should be reserved for patients with severe nodular acne who are
unresponsive to conventional therapy, including systemic antibiotics. In
addition, for female patients of childbearing potential, Claravis is indicated
only for those females who are not pregnant and will not become pregnant.
Claravis will compete in the Accutane marketplace that had total annual
sales of approximately $523 million for the most recent twelve months ending
January 2003.
Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in
the development, manufacture and marketing of generic and proprietary
pharmaceuticals.
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; 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 statement. The Company undertakes no
obligation to publicly update any forward-looking statements.
SOURCE Barr Laboratories, 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 Laboratories, Inc.,
+1-845-348-6808, ccox@barrlabs.com
NOTE TO EDITORS: Barr Laboratories, Inc. news releases are
available free of charge through PR Newswire's News On-Call site
at http://www.prnewswire.com/corp/089750.html. Barr news
releases and corporate information are also available on Barr's
home page (www.barrlabs.com). For complete indications, warnings
and contraindications, contact Barr Laboratories' Professional
Services Department at 1-800-Barr Lab. Claravis(TM) is a
trademark of Barr Laboratories, Inc. Accutane(R) is a registered
trademark of Roche Pharmaceuticals.
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