BC43 Inter-amer 30

     
BW20021107002583  20021108T071938Z UTC


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

    Business Editors
    UK REGULATORY NEWS

    BARCELONA, Spain----(BUSINESS WIRE)--Nov. 8, 2002--

The issuer advises that the following replaces the
(ELI-LILLY-&-CO)(BC43) Eli Lilly and Company: Postmenopausal Women
Taking Lilly's Evista Show Strong Results Despite Prior HRT Use --
announcement released yesterday at 18:07 GMT under BW20021107002438.

The full amended text appears below: 

-0-
*T 

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

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 an 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 postmenopausal 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 postive 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.

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 postmenopausal women with osteoporosis without prevalent
(prior or existing) 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 was 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 and Rheumatology, Cedars-Sinai Medical Center, Los Angeles.
"These study results illustrate that postmenopausal women with
osteoporosis are also at risk for cardiovascular and breast cancer
events. This information will be useful for physicians in formulating
decisions with regards to therapies for osteoporosis prevention, based
on both skeletal and nonskeletal effects."

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
postmenopausal women with low bone mineral density (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.

*T 

   Short Name: LILLY (Eli) & Co.
   Category Code: MSC
   Sequence Number: 00001173
   Time of Receipt (offset from UTC): 20021107T174750+0000

    --30--eb/ny* 

    CONTACT: Lilly
             Sondra McQueary, 317/985-4045
             or +34 93 318 5200 ext. 621
             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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