Letter of Intent Signed
11 September 2003 - 5:03PM
UK Regulatory
RNS Number:6408P
Galen Holdings PLC
11 September 2003
Barr and Galen Sign Letters of Intent for Barr to Acquire Exclusive Rights to
Galen's Loestrin(R) Oral Contraceptive Product
Parties Resolve Outstanding Patent Challenges on Estrostep(R) and femhrt; Galen
to Receive Option to License Barr's Generic Ovcon(R) Oral Contraceptive
Woodcliff Lake, NJ and Craigavon, Northern Ireland - September 11, 2003- Barr
Laboratories, Inc. (NYSE-BRL) and Galen Holdings PLC (LSE: GAL.L, NASDAQ-GALN)
today announced that they have 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 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.
These transactions are subject to negotiation of definitive agreements,
completion of due diligence and other conditions, including Hart-Scott-Rodino
antitrust review and final approval by the Boards of Directors of both Barr and
Galen. Barr and Galen expect to close the transaction by December 31, 2003.
"These agreements would add a significant new product to Barr's growing
portfolio of oral contraceptive products," said Bruce L. Downey, Barr's Chairman
and Chief Executive Officer. "It also would allow both parties to resolve
pending patent litigation in a way that will ensure Barr can bring alternative
femhrt(R) and Estrostep(R) products to market prior to patent expiration, which
will benefit our female healthcare products consumers."
Commenting on the announcement, Roger Boissonneault, Galen's Chief Executive
Officer said, "This is a good deal for both companies. We would exchange a
non-core asset for significant value and for a fair resolution of outstanding
patent issues. While we remain confident in the strength of the Estrostep(R)
and femhrt(R) patents, this transaction would allow us to remove the
uncertainties inherent in any litigation. In addition, the acquisition of a
generic Ovcon(R), along with introduction of our Ovcon(R) line extension, will
enable us to continue to grow this important asset."
Loestrin(R) Product Rights and Patent Challenge Settlement
Under the terms of the letter of intent, Barr would acquire from Galen the
exclusive rights to manufacture and market Loestrin(R) products in the United
States and Canada. Also under the letter of intent, Galen would grant Barr a
non-exclusive license to launch a generic version of femhrt(R), six months prior
to the expiration of the patent on femhrt(R). Galen would also grant Barr a
non-exclusive license to launch a generic version of Estrostep(R), six months
prior to the expiration of the patent on Estrostep(R). Finally, Barr would
receive an exclusive royalty bearing license to develop certain oral
contraceptives under a patent owned by Galen. In consideration of these rights
and assets, Barr would make a one-time payment to Galen of approximately $45
million.
Option Agreement Related to Ovcon(R) Oral Contraceptive
Under the terms of the exclusive option agreement, Barr would grant Galen an
option to acquire an exclusive license under Barr's ANDA for Ovcon(R) 35, which
is currently pending at the U.S. Food & Drug Administration (FDA). Within 30
days of FDA approval of Barr's ANDA for Ovcon(R), Galen would have the right to
exercise its option. If Galen chooses to exercise the option, it would be
granted a five-year exclusive license under Barr's ANDA to sell the product. At
the end of the five-year term, Barr would grant Galen a non-exclusive license to
continue selling the product. In consideration of this transaction, Galen would
make a $1 million payment to Barr at the time of the grant of the option and a
$19 million payment to Barr at the time the exclusive license agreement is
signed.
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.
CONTACTS:
Barr Laboratories, Inc.
Carol A. Cox Tel: 201-930-3720
email: ccox@barrlabs.com
Galen Holdings PLC
David Kelly Tel: 44 (0) 283 833 4974 ext. 3449
Sr. Vice President, Finance and Planning
Financial Dynamics Tel: 44 (0) 207 831 3113
Jonathan Birt / Francetta Carr
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. 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 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
for their products; 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. Neither Barr nor Galen
undertakes any obligation to publicly update any forward-looking statements,
whether as a result of new information, future events or otherwise.
(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.)
# # #
This information is provided by RNS
The company news service from the London Stock Exchange
END
LOIIIFSRARILLIV