WOODCLIFF LAKE, N.J., June 4 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr
Laboratories, Inc. ("Barr"), and Eli Lilly & Company ("Lilly") voluntarily
stipulated that all claims asserted by Lilly against Barr and all
counterclaims asserted by Barr against Lilly in the patent litigation
between the two parties related to Lilly's Prozac(R) Weekly(TM) (Fluoxetine
Hydrochloride) Capsules, USP 90 mg have been dismissed. The patent
litigation had been initiated in May 2006 when Lilly sued Barr seeking to
protect its Prozac Weekly product from generic competition. Barr indicated
it believes it is the first to file an Abbreviated New Drug Application
(ANDA) with the U.S. Food & Drug Administration (FDA) for the 90 mg capsule
product and, consequently, will be entitled to 180 days exclusivity when
its ANDA receives FDA approval.
Barr filed an ANDA for Fluoxetine Hydrochloride Capsules, USP 90 mg
with the FDA in September 2001, and received notification of the
application's acceptance for filing in November 2001. Barr's ANDA contained
a Paragraph IV certification to the patents listed in the Orange Book for
this product. Following receipt of notice from FDA, Barr notified Lilly of
its ANDA filing. Lilly did not sue Barr within 45 days of receiving this
notice. On March 21, 2006, Lilly obtained a reissue patent, U.S. Patent
RE39,030, and subsequently listed that patent in the Orange Book. Barr
amended its ANDA to include a Paragraph IV certification to that patent. On
May 10, 2006, after receiving notice from Barr, Lilly filed suit against
Barr on the reissue patent in the U.S. District Court, Southern District of
Indiana, to prevent Barr from proceeding with the commercialization of this
product. On June 1, 2007, Barr and Lilly voluntarily dismissed all claims
and counterclaims in the patent litigation.
Prozac Weekly is indicated for the continuation treatment phase of
major depressive disorder. Prozac Weekly Capsules, USP 90 mg has current
annual sales of approximately $30 million, based on IMS sales data for the
twelve months ended March 2007.
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. 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.
 back to top
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
|
