FTC Request for Information

RNS Number:6399T
Galen Holdings PLC
23 December 2003

Barr Laboratories, Inc.
Carol A. Cox                                  Tel: [phone]
                                              email: [e-mail]

Galen Holdings PLC
David Kelly                                  Tel:  [phone] ext. 3634
Sr. Vice President, Finance and Planning


Financial Dynamics                           Tel:  [phone]
Francetta Carr



Barr and Galen Receive FTC Request for Information Related to Proposed
Transactions



Woodcliff Lake, NJ and Craigavon, Northern Ireland - December 23, 2003- Barr
Laboratories, Inc. (NYSE-BRL) ("Barr") and Galen Holdings PLC (LSE: GAL.L,
NASDAQ-GALN) ("Galen") today announced that they have recently received a letter
from the Federal Trade Commission's (FTC) Bureau of Competition requesting that
they voluntarily provide certain information concerning Barr's proposed
acquisition of the U.S. and Canadian rights to Galen's Loestrin(R) and Loestrin
(R) FE oral contraceptive products and the proposed settlement of pending patent
litigation between Barr and Galen.  The letter also requests information
concerning the proposed option for Galen to acquire an exclusive license to
Barr's generic version of Galen's Ovcon(R) 35 oral contraceptive.



The FTC's Bureau of Competition previously reviewed the proposed transactions
under the Hart-Scott-Rodino Act.  On October 24, 2003, the Hart-Scott-Rodino
waiting period expired, permitting the parties to close the transactions.
However, on December 16, 2003, Barr and Galen received letters from another
group in the FTC's Bureau of Competition announcing that group's intention to
review the proposed transactions.



The FTC specifically stated that its letter should not viewed as an accusation
by the Commission or its staff of any wrongdoing. Barr and Galen believe that
the proposed transactions are lawful and proper and intend to cooperate fully
with the request. Barr and Galen are currently unable to determine the impact,
if any, that the FTC's request would have on the closing of the proposed
transactions, which is currently scheduled to occur by February 1, 2004.



Background

In September 2003, Barr and Galen announced that they had signed a letter of
intent for Barr to acquire from Galen the exclusive rights in the United States
and Canada for Loestrin(R) and Loestrin(R) FE oral contraceptive products.  The
proposed transaction also would include a settlement of pending patent
litigation between Barr and Galen regarding Galen's femhrt(R) hormone therapy
and Estrostep(R) oral contraceptive products that would allow Barr to launch
generic versions of those products six months prior to patent expiry.



Under the terms of a separate letter of intent, Barr would grant Galen an option
to acquire an exclusive license for Barr's generic version of Galen's Ovcon(R)
35 oral contraceptive. Barr has a pending Abbreviated New Drug Application
(ANDA) for the 0.4 mg norethindrone/35 mg ethinyl estradiol 21-day and 28-day
generic Ovcon(R) products.



Barr Laboratories, Inc. is engaged in the development, manufacture and marketing
of generic and proprietary pharmaceuticals.



Galen is an international pharmaceutical company based in Craigavon, Northern
Ireland and Rockaway, New Jersey, US.  The Galen group of companies develops,
acquires and manufactures branded prescription pharmaceutical products, which
are promoted by the group's sales and marketing divisions in the UK, Ireland and
the US.



Forward-Looking Statements

The following sections contain a number of forward-looking statements. To the
extent that any statements made in this press release contain information that
is not historical, these statements are essentially forward-looking.
Forward-looking statements can be identified by their 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 statements. Such risks and uncertainties
include: 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 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 for their products; the success of our product development
activities; 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; the ability to develop and
launch new products on a timely basis; the availability of raw materials; the
availability of any product we purchase and sell as a distributor; our mix of
product sales between manufactured products, which typically have higher
margins, and distributed products; 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 new enterprise resource
planning systems; fluctuations in operating results, including the effects on
such results from spending for research and development, sales and marketing
activities and patent challenge activities; and other risks detailed from time
to time in our filings with the Securities and Exchange Commission.



(EDITOR'S ADVISORY: Barr Laboratories, Inc. news releases are available free of
charge through PR Newswire's News On-Call fax service.  For a menu of Barr's
previous releases, or to receive a specific release via fax call: 800-758-5804
-- ext. 089750.  Barr news releases and corporate information are also available
on Barr's website (www.barrlabs.com).  For further information on Galen, please
visit www.galenplc.com.  Loestrin(R), Loestrin(R) FE, femhrt(R), Estrostep(R)
and Ovcon(R) are registered trademarks of Galen (Chemicals) Limited.)



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