Company Changes Application to a Paragraph III
WOODCLIFF LAKE, N.J., June 11 /PRNewswire-FirstCall/ -- Barr
Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL),
today announced the dismissal of litigation related to its challenge of the
patent protecting Eli Lilly and Company's ZYPREXA(R) Zydis(R) (Olanzapine)
Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg. Following the
Federal Circuit's affirmance of a decision by the trial court in favor of
Eli Lilly on this patent in a suit against Zenith Goldline Pharmaceuticals,
Inc., Teva Pharmaceuticals USA, Inc. and Dr. Reddy's Labs, Ltd., the
Company changed the patent certification for its Abbreviated New Drug
Application (ANDA) that is currently pending at the U.S. Food & Drug
Administration (FDA) for Olanzapine Orally Disintegrating Tablets from a
paragraph IV to a paragraph III. The patent litigation dismissal is a
result of the Company's change to a paragraph III certification.
The patent listed in the Orange Book for ZYPREXA Zydis expires on April
23, 2011 and the associated pediatric exclusivity expires on October 23,
2011. The Company anticipates receiving final FDA approval upon expiration
of the patent, and any related exclusivities that may be sought and
granted.
Barr filed its ANDA containing a paragraph IV certification for a
generic ZYPREXA Zydis product with the FDA in August 2004, and received
notification of the application's acceptance for filing in September 2004.
Following receipt of the notice from the FDA, Barr notified Lilly
Industries Limited, the patent owner, and Eli Lilly & Company, the New Drug
Application (NDA) holder. On December 1, 2004, Lilly Industries Limited and
Eli Lilly & Company filed suit in U.S. District Court, Southern District of
Indiana to prevent Barr from proceeding with the commercialization of its
product. The FDA issued a tentative approval for Barr's ANDA for Olanzapine
Orally Disintegrating Tablets in November 2006. The Company notified FDA of
the change in its certification in April 2007 and the litigation between
the Company and Lilly was subsequently dismissed.
ZYPREXA (olanzapine) is indicated for the treatment of schizophrenia
and for the short-term treatment of acute manic episodes associated with
Bipolar I disorder. The product had annual sales of approximately $252
million for the twelve months ended March 2007, based on IMS sales data.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company
that operates in more than 30 countries worldwide and is engaged in the
development, manufacture and marketing of generic and proprietary
pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.
A holding company, Barr operates through its principal subsidiaries: Barr
Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its
subsidiaries. The Barr Group of companies markets more than 115 generic and
25 proprietary products in the U.S. and more than 1,200 products globally
outside of the U.S.
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 in the markets where we operate;
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 (such as PLIVA d.d.) and
products we acquire and implementing our new SAP 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; our expansion into
international markets through our PLIVA acquisition, and the resulting
currency, governmental, regulatory and other risks involved with
international operations; our ability to service our significantly
increased debt obligations as a result of the PLIVA acquisition; changes in
generally accepted accounting principles; and other risks detailed in our
SEC filings, including in our Transition Report on Form 10-K/T for the six
months ended December 31, 2006.
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.
SOURCE Barr Pharmaceuticals, Inc.
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Related links:
http://www.barrlabs.com
http://www.prnewswire.com/comp/089750.html/
CONTACT:
Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com
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