BC43 Inter-amer 30

     
BW20021107002438  20021107T180746Z UTC


( BW)(ELI-LILLY-&-CO)(BC43) Eli Lilly and Company: Postmenopausal
Women Taking Lilly's Evista Show Strong Results Despite Prior HRT Use

    Business Editors
    UK REGULATORY NEWS

    BARCELONA, Spain--(BUSINESS WIRE)--Nov. 7, 2002--

New Analyses Presented at WHO Scientific Meeting Show Reductions in
Vertebral Fracture and Breast Cancer Risk

Several new analyses from an osteoporosis study of Eli Lilly and
Company's Evista(R) (raloxifene HCl, 60 mg), were presented at the
World Health Organization's (WHO) Symposium on Social and Economic
Aspects of Osteoporosis and Osteoarthritis. Among them was a timely
analysis that demonstrated that Evista produced significant reductions
in vertebral fracture risk and breast cancer risk among postmenopausal
women with osteoporosis, irrespective of women's prior use of hormone
replacement therapy (HRT). Evista is not an estrogen, an estrogen
replacement therapy (ERT) or a hormone replacement therapy (HRT). It
belongs to a separate class of drugs called selective estrogen
receptor modulators (SERMs) and has a unique profile. It is indicated
for the prevention and treatment of osteoporosis in post-menopausal
women.

Data collected from the Multiple Outcomes of Raloxifene Evaluation
(MORE) trial, showed that postmenopausal women who were prior HRT
users and took Evista treatment daily for four years had a 54 percent
reduction in the risk of new vertebral fractures compared to placebo.
In addition, prior HRT users who took Evista treatment daily for four
years had a 77 percent reduction in the risk of invasive breast cancer
compared to those taking placebo. These statistically significant
findings were similar among those women taking Evista who had no prior
HRT use.

"These Evista study results are significant especially given the
termination of two HRT studies recently, WHI in the US and WISDOM in
the UK," said study author Olof Johnell, MD, General Hospital, Malmo,
Sweden. "They confirm for physicians and post-menopausal women the
strength of Evista's bone profile and Evista's ability to reduce the
risk of invasive breast cancer."

The MORE study was a multicenter, placebo-controlled, randomized,
double-blind osteoporosis treatment trial in 25 countries over four
years which included 7,705 postmenopausal women, who were up to 80
years of age and at least two years post-menopause.

Other MORE Analyses

A separate analysis of the placebo population in the MORE study,
designed to compare fracture, cardiovascular and breast cancer event
rates in post-menopausal women with osteoporosis without prevalent
vertebral fractures at three years, was also presented at this
meeting. The study showed, at three years, the likelihood of having a
vertebral fracture was 16 times that of having a hip fracture (4.26
percent of the women on placebo had a new x-ray determined vertebral
fracture, 0.25 percent of placebo treated women had a hip fracture).
The likelihood of a vertebral fracture, any cardiovascular event
(coronary or cerebrovascular) or breast cancer event were similar
(4.26 percent of women on placebo at three years had a vertebral
fracture, while 2.15 percent on placebo had a cardiovascular event and
1.54 percent on placebo were diagnosed with breast cancer events).
Furthermore, the likelihood of a cardiovascular event, invasive breast
cancer, or clinical (painful) vertebral fracture was similar, and each
of these events was approximately five times more likely to occur than
hip fracture(1).

"Osteoporosis is one of the three major health concerns facing
postmenopausal women. Others include cardiovascular events and breast
cancer," explained study author Stuart Silverman, MD, Department of
Medicine, University of California, Los Angeles, US. "These study
results will be useful for physicians in formulating decisions
regarding osteoporosis prevention, particularly vertebral prevention,
particularly vertebral fracture prevention, and treatment strategies
for postmenopausal women."

A third analysis from the MORE study focused on the effect of
prevalent mild vertebral fractures, determined by spinal radiographs,
on the risk of new moderate and severe vertebral fractures in
post-menopausal women with low BMD. The analysis revealed that the
existence of a mild vertebral fracture -- though often not recognized
-- increased the risk of further, more severe vertebral fractures in
postmenopausal women by three-fold compared to the women who did not
have a previous vertebral fracture.

Lead author Pierre Delmas, MD, PhD Hopital Edouard Herriot, Lyon,
France said, "This information reinforces why it is so important to
treat the first fracture, and that fracture is most likely to be a
vertebral fracture rather than the much publicized hip fracture."

Side effect information

No medicine is right for everyone, and Evista is no exception. Evista
use was associated with some side effects, the majority of which were
reported as mild. The most common side effects were an increase in hot
flushes and leg cramps. Venous thromboembolic events or VTE (deep vein
thrombosis, or blood clots in the veins and pulmonary embolism or
blood clots in the lung), is an infrequent but serious side effect.
VTE is observed at a rate similar to that seen with HRT. Women who are
or can become pregnant, women who are breast-feeding or women with
existing endometrial or breast cancer should not take Evista. It
should also not be taken by women with liver disease or those with
unexplained vaginal bleeding.

Lilly background information

Lilly, a leading innovation driven corporation, is developing a
growing portfolio of best-in-class pharmaceutical products by applying
the latest research from its own worldwide laboratories, and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, USA, Lilly provides answers - through medicines and
information - for some of the world's most urgent medical needs.

(1) SL Silverman et al. Comparison of Fracture, Cardiovascular, and
Breast Cancer Event Rates at 3 Years in Placebo-Treated
Post-menopausal Women with Osteoporosis without Prevalent Vertebral
Fractures: Results from the MORE Study. WHO Third Symposium on the
Social and Economic Aspects of Osteoporosis and OsteoArthritis.
November 2002.

   Short Name: LILLY (Eli) & Co.
   Category Code: MSC
   Sequence Number: 00001170
   Time of Receipt (offset from UTC): 20021107T174750+0000

    --30--djl/cl* mh/uk

    CONTACT: Lilly
             Sondra McQueary, 317/985-4045
             Lisa Swingler, +44 1276 484886 

    KEYWORD: INDIANA SPAIN UNITED KINGDOM INTERNATIONAL EUROPE
    INDUSTRY KEYWORD: MEDICAL BIOTECHNOLOGY PHARMACEUTICAL PRODUCT
    SOURCE: Eli Lilly and Company

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