Galen Holdings PLC
16 June 2003
INNOVATIVE ESTROGEN THERAPY, FEMRINGTM, LAUNCHES IN U.S. MARKET
Only vaginal estrogen product indicated to relieve both vaginal symptoms and hot
flushes in menopausal women in the U.S.
Craigavon, Northern Ireland, UK/Rockaway, New Jersey, US, 16 June 2003 - Galen
Holdings PLC ('Galen') (LSE: GAL.L, Nasdaq: GALN), today announced the
availability of FemringTM in the United States, the only vaginally delivered
estrogen therapy to provide dual symptom control, treating both the vaginal and
vasomotor (hot flushes, night sweats) symptoms of menopause. FemringTM offers
today's active, youthful woman an easy-to-use, effective choice in hormone
Approved by the U.S. Food and Drug Administration (FDA) in March 2003, FemringTM
is a flexible, self-inserted ring which delivers estrogen at a steady and
consistent rate during the three-month dosing period. It offers women an
innovative, convenient solution they only need to think about four times a year,
as opposed to once-daily pill dosing and weekly applications of patch therapies.
'FemringTM's effectiveness in treating both hot flushes and vaginal symptoms is
a novel advancement in the estrogen therapy market,' said Dr. Susan Ballagh,
Assistant Professor of the Department of Obstetrics and Gynecology at Eastern
Virginia Medical School. 'As women get older, they want to remain physically
and sexually active, and they don't want to be slowed down by hot flushes and
vaginal dryness.' The physical and sexual effects of menopause are an important
public health consideration, as more women than ever before approach menopause.
It is estimated that in the next decade, as many as 52 million women in the U.S.
will be age 50 or older.
Dr. Ballagh also was a lead investigator in the RING Trial, the largest-ever
study looking at symptoms of menopause and patient acceptability of vaginal ring
technology. The study, which was commissioned by Warner Chilcott, Inc. and will
be released this month, involved more than 6,000 women. Data collected from
almost 5,000 women between the ages of 45-60 (a sub-set of study participants)
showed that 50 percent of menopausal women suffering from hot flushes also
reported experiencing vaginal dryness and/or painful intercourse. These results
reinforce the importance of providing relief from both hot flushes and vaginal
symptoms and validate the use of ring technology to deliver estrogen.
Marketed by Warner Chilcott, the FemringTM brand will be supported by a
national DTC advertising campaign to be launched in Q3/Q4 2003.
Roger Boissonneault, Chief Executive Officer, Galen, said: 'Galen is committed
to being a partner for women at all stages of life. We are pleased to announce
the availability of FemringTM to help improve the lives of the millions of
women entering menopause.'
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
# # #
Galen Holdings PLC
David Kelly, Sr. Vice President, Finance and Planning Tel: 44 (0) 283 833 4974
Sophie Pender-Cudlip / Francetta Carr Tel: 44 (0) 207 831 3113
Heidi Lorman Tel: 001 212 414 5639
For further information on Galen, please visit www.galenplc.com
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.
Notes to Editors
For full prescribing information, please contact Heidi Lorman at +001 212 414
5639 and request a fax and/or e-mail version of the product insert (PI).
Menopause is a natural biological process associated with hormonal, physical and
emotional changes in a woman's life that mark the end of her childbearing years.
Menopause is clinically defined as the point at which a woman has not had a
menstrual period for 12 months and has not been ill, pregnant, breastfeeding or
using a medication that might cause menstruation to cease unnaturally. The
majority of women enter menopause between the ages of 45 and 54, with most women
entering menopause between the ages of 50 and 51. Some women, however,
experience menopause much earlier or even later. Menopause also may be induced
as a result of surgery that removes both ovaries, with or without a hysterectomy
(removal of the uterus), as well as by chemotherapy or pelvic radiation therapy
Women experience menopause in highly individual ways. Although about 75 percent
of women report some troublesome symptoms during menopause, the severity and
frequency of symptoms varies widely from woman to woman. Some women experience
few symptoms (or none at all), while others experience persistent symptoms that
may be uncomfortable, disruptive and difficult to manage. There are a number of
treatment options available to address the symptoms of menopause.
FemringTM, a flexible, self-inserted ring, is the only vaginal estrogen product
proven effective in the treatment of hot flushes and vaginal symptoms. A single
FemringTM delivers estrogen at a steady and consistent rate during the
three-month dosing period, offering women both dual symptom relief and
convenient dosing. FemringTM is available in two prescription strengths, 0.05
mg/day and 0.1 mg/day. FemringTM does not contain progestin.
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 FemringTM were headache, intermenstrual bleeding, vaginal
candidiasis, breast tenderness, back pain and abdominal distension. 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. FemringTM should not be used in
patients with known hypersensitivity to any of its compounds or known or
FemringTM therapy is indicated in the treatment of moderate to severe vasomotor
symptoms and vulvar and vaginal atrophy associated with menopause. When
prescribing solely for the treatment of vulvar and vaginal atrophy, other
vaginal products should be considered.
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