Femring(TM) - FDA Approval

RNS Number:0330J
Galen Holdings PLC
21 March 2003


                               GALEN HOLDINGS PLC

                       FEMRING(TM) RECEIVES FDA APPROVAL


Craigavon, Northern Ireland, UK / Rockaway, New Jersey, US, 21st March 2003 -
Galen Holdings PLC (LSE: GAL, Nasdaq: GALN), the international pharmaceutical
company, today announced the U.S. Food and Drug Administration (FDA) approval of
Femring(TM) (estradiol acetate vaginal ring).


Femring(TM) is the first vaginal estrogen product indicated to treat both the
hot flushes and vaginal symptoms associated with menopause.  It will offer women
effective, convenient and easy-to-use symptom control, with a steady three-month
supply of estradiol in just one dose.  Galen plans to introduce Femring(TM) into
the US market in June 2003.


Femring(TM), a flexible, self-inserted ring, is an innovative response to the
needs of today's menopausal women.  It is documented that 75 percent of
post-menopausal women experience vasomotor symptoms (e.g. hot flushes, night
sweats) and up to three quarters report vaginal symptoms (e.g. dryness, painful
intercourse).  Many women receiving estrogen tablets or patches still experience
vaginal symptoms.  Femring(TM) is the only vaginal estrogen product proven
effective in the treatment of hot flushes and vaginal symptoms.  In addition, a
single Femring(TM) delivers estrogen at a steady and consistent rate during the
three-month dosing period, offering women both dual symptom relief and
convenient dosing.  Femring(TM) will be available in two strengths, 0.05 mg/day
or 0.1 mg/day.


"Currently, there is no other vaginal product on the market that is indicated to
deliver both systemic and vaginal symptom relief, and none of the available
products provide a three-month dose of estrogen.  The unique ability of Femring
(TM) to effectively control hot flushes and night sweats, as well as improve
vaginal atrophy over a three-month period, makes this product an excellent
treatment solution for today's busy, active women," said Arthur Haney, Director
of the Department of Reproductive Endocrinology & Infertility in the Department
of Obstetrics and Gynecology at Duke University Medical Center.


Participants in Femring(TM) clinical trials reported high rates of patient
satisfaction with the product's effectiveness, comfort and ease-of-use.  Data
from a study of nearly 6,000 women in the US using a placebo ring demonstrated
that women using the vaginal ring technology now available with Femring(TM) find
the delivery system to be highly acceptable, comfortable and easy-to-use.  Women
had few problems inserting or removing the ring, and the majority of women
reported they were not aware of wearing the ring.  Eighty-five percent of
subjects expressed the desire that healthcare professionals offer the ring when
discussing hormone therapy options with their patients.


Menopause, a natural biological process associated with hormonal, physical and
emotional changes in a woman's life that mark the end of her childbearing years
begins at an average age of 51.  It is estimated that in the next decade, more
women than ever before - as many as 52 million in the US - will be age 50 or
older.  "As the baby boomer generation ages and an increasing number of women
enter menopause, addressing the symptoms of menopause is a major health concern.
We are pleased to offer women a cutting-edge solution that gives them
effective and reliable control over their symptoms with the added benefit of
being a discrete option with convenient four-times-a-year dosing," said Roger
Boissonneault, Chief Executive Officer, Galen Holdings.


Estrogens with or without progestins should not be used for the prevention of
cardiovascular disease.  Estrogens have been reported to increase the risk of
endometrial carcinoma.  The most frequently reported adverse events in clinical
trials for Femring(TM) were headache, intermenstrual bleeding, vaginal
candidiasis and breast tenderness.  These events are commonly observed with all
estrogen products.  Estrogens should not be used in individuals with any of the
following conditions: undiagnosed abnormal genital bleeding; known, suspected or
history of cancer of the breast; known or suspected estrogen-dependent
neoplasia; active deep vein thrombosis, pulmonary embolism or a history of these
conditions; active or recent arterial thromboembolic disease.  Femring(TM)
should not be used in patients with known hypersensitivity to any of its
compounds.


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:


Galen Holdings PLC
David Kelly, Sr. Vice President, Finance and Planning      Tel: [phone]
                                                             44 (0) 283 833 4974


Financial enquiries:
Financial Dynamics
Sophie Pender-Cudlip / Francetta Carr                   Tel: [phone]


Product enquiries:
Biosector 2
Brynn Thomas                                               Tel: [phone]


For further information on Galen, please visit www.galenplc.com


Note:


Forward looking statements in this report, including, without limitation,
statements relating to Galen's plans, strategies, objectives, expectations,
intentions and adequacy of resources, are made pursuant to the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of 1995.  These
forward looking statements involve known and unknown risks, uncertainties and
other factors that may cause the actual results, performance or achievements of
Galen to be materially different from any future results, performance or
achievements expressed or implied by such forward looking statements.  These
factors include, among others, the following:  Galen's ability to manage its
growth, government regulation affecting the development, manufacture, marketing
and sale of pharmaceutical products, customer acceptance of new products,
competitive factors in the industries in which Galen operates, the loss of key
senior management or scientific staff, exchange rate fluctuations, general
economic and business conditions, and other factors described in filings of
Galen with the SEC.  Galen undertakes no obligation to publicly update or revise
any forward looking statement, whether as a result of new information, future
events or otherwise.



                      This information is provided by RNS
            The company news service from the London Stock Exchange
END

MSCDGGZFVMLGFZG