Barr
Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr
Laboratories, Inc. has received tentative approval from the U.S. Food and
Drug Administration (FDA) for its generic version of Eli Lilly and
Company's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets,
5mg, 10mg, 15mg and 20mg. The Company anticipates receiving final approval
following the expiration of the 30-month stay in April 2007.
The patent listed in the Orange Book for ZYPREXA Zydis expires on April
23, 2011. Barr's Abbreviated New Drug Application (ANDA) alleges that the
Orange Book listed patent is invalid, unenforceable and/or would not be
infringed by Barr's product.
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, formally initiating the patent challenge process under the
Hatch-Waxman Act.
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 $246
million for the twelve months ended September 2006, based on IMS sales
data.
A tentative approval reflects FDA's preliminary determination that a
generic product satisfies the substantive requirements for approval,
subject to the expiration of all statutorily imposed non-approval periods.
A tentative approval does not allow the applicant to market the generic
drug product.
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 Company markets more than 120 generic and 25 proprietary
products in the U.S. and more than 550 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; 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 (including PLIVA d.d.) 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;
our expansion into international markets through the completion of the
PLIVA acquisition, and the resulting currency, governmental, regulatory and
other risks involved with international operations; our ability to service
our increased debt obligations as a result of the PLIVA acquisition;
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, 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.
Barr Pharmaceuticals, Inc.
barrlabs
View drug information on Zyprexa.