Lilly Announces Review of Data on Long-Term Raloxifene Treatment for Postmenopausal Osteoporosis Published in Current Medical Research & Opinion

INDIANAPOLIS, Aug. 9, 2011 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY)
today announced that data on EVISTA® (raloxifene HCl tablets) therapy for more
than three years was published online in Current Medical Research & Opinion. The
review includes summaries of previously published information; new, previously
unpublished observations; and new data on EVISTA use. EVISTA is indicated for
the treatment of osteoporosis in postmenopausal women and reduction in risk of
invasive breast cancer in postmenopausal women with osteoporosis.

The majority of available data came from the Multiple Outcomes of Raloxifene
Evaluation (MORE) trial and the Continued Outcomes of Raloxifene Evaluation
(CORE) trial. In these trials, patients were evaluated for up to eight years.
While available information is supportive of EVISTA use for more than three
years, the optimum duration of EVISTA therapy is not known.

“Because of the chronic nature of postmenopausal osteoporosis and the risk of
invasive breast cancer associated with the disease in postmenopausal women with
osteoporosis, it is critical to evaluate medications that treat these conditions
that require therapy over a prolonged period of time,” said lead author Robert
Recker, M.D., professor of medicine, chief, division of endocrinology, director,
Osteoporosis Research Center, Creighton University School of Medicine.

Use of EVISTA was evaluated by changes in vertebral fracture risk reduction,
bone mineral density (BMD), markers of bone turnover, iliac crest bone biopsies,
and invasive breast cancer risk reduction:

— Vertebral fracture risk reduction: In the MORE trial, the relative risk
reduction during the fourth year of the study was similar to the
relative risk reduction during years zero to three.
— BMD: Patients who stopped EVISTA therapy in the one-year period between
the end of the MORE trial and the beginning of the CORE trial
experienced a significant decrease in BMD. Once treatment resumed in the
CORE trial, lumbar spine and femoral neck BMD increased in the EVISTA
group.
— Bone turnover:In a previously unpublished analysis of data from the MORE
study, patients who received EVISTA for three continuous years had lower
bone resorption as measured by c-terminal telopeptide (CTX) values, with
the average being similar to that found in premenopausal women. EVISTA
is not for use in premenopausal women.
— Iliac crest bone biopsies: Newly reported data from a subset of patients
in the CORE trial included results of iliac crest biopsies in three
patients treated with EVISTA for eight years. These iliac crest biopsies
showed normal bone and bone cells and double label in all specimens.
— Invasive breast cancer risk reduction: In a subset of postmenopausal
women followed for up to eight years from randomization of the MORE
trial to the end CORE, a reduction in the incidence of invasive breast
cancer was observed in the EVISTA versus placebo group. The long term
effects and the recommended length of therapy are not known.

Study safety findings included:

— In clinical trials, patients in the EVISTA versus placebo group had
higher incidence of venous thromboembolic events (blood clots in the
legs, lungs or eyes), including deep vein thrombosis and pulmonary
embolism, compared with patients who received placebo. EVISTA is
contraindicated in women with active or past history of venous
thromboembolism (VTE), including deep vein thrombosis, pulmonary
embolism and retinal vein thrombosis.
— The safety profile of EVISTA after four years of treatment was similar
to that of EVISTA following three years of therapy.
— Additional adverse events (>2% and more common with EVISTA than with
placebo) included hot flashes, leg cramps, swelling, flu-like symptoms,
joint pain and sweating.

“Lilly is committed to providing information regarding our therapies to help
healthcare professionals and their patients engage in more informed discussions
about available treatment options for postmenopausal osteoporosis,” said
co-author John Krege, M.D., medical fellow, Eli Lilly and Company.

About the Review

“Long-term Raloxifene for Postmenopausal Osteoporosis” is a literature review of
available information concerning EVISTA use for greater than three years for the
treatment of postmenopausal osteoporosis and invasive breast cancer risk
reduction in postmenopausal women with osteoporosis. Two reviewed studies were
the Multiple Outcomes of Raloxifene Evaluation (MORE) trial and the Continued
Outcomes of Raloxifene Evaluation (CORE) trial. The review includes summaries of
previously published information, as well as a number of previously unpublished
observations from analyses of the clinical study databases. In addition, new
data from three patients who underwent iliac crest bone biopsies after eight
years of EVISTA therapy were reported.

About EVISTA® (raloxifene HCl tablets)

EVISTA is an estrogen agonist/antagonist, commonly referred to as a selective
estrogen receptor modulator (SERM), which appears to act like estrogen in bone
and to block the effects of estrogen in some tissues. It is an osteoporosis
therapy for postmenopausal women that also reduces the risk of invasive breast
cancer in postmenopausal women with osteoporosis.

EVISTA is approved by the U.S. Food and Drug Administration (FDA) for the
treatment and prevention of osteoporosis in postmenopausal women. EVISTA is also
indicated for the reduction in risk of invasive breast cancer in postmenopausal
women with osteoporosis. There are Important Limitations of Use for breast
cancer risk reduction:

— There are no data available regarding the effect of EVISTA on invasive
breast cancer incidence in women with inherited mutations (BRCA1, BRCA2)
to be able to make specific recommendations on the effectiveness of
EVISTA.
— EVISTA is not indicated for the treatment of invasive breast cancer or
reduction of the risk of recurrence.
— EVISTA is not indicated for the reduction in the risk of noninvasive
breast cancer.

EVISTA 60 mg tablets are taken once daily and can be taken with calcium and
vitamin D supplements, with or without food.

Important Safety Information about EVISTA® (raloxifene HCl tablets)

What is the most important information patients should know about EVISTA?

Patients should not take EVISTA if they have had or are at risk for
getting blood clots in the legs, lungs or eyes, as it may increase
the risk of blood clots. Patients should stop taking EVISTA and call
their doctor if they have leg pain or warmth, swelling of the legs,
hands or feet, chest pain, shortness of breath or a sudden vision
change, as these may be signs of a blood clot. Being unable to move
around for long periods may increase this risk. If patients will
need to be still for a long time, they should talk to their doctor
about ways to reduce the risk of blood clots.

EVISTA does not increase the risk of a heart attack or stroke in
women who have had or are at risk for a heart attack; however,
EVISTA increases the likelihood of dying from stroke in these women,
should one occur. Before taking EVISTA patients should tell their
doctor if they have had a stroke, a mini-stroke, irregular
heartbeat, high blood pressure, heart attack, history of smoking, or
believe they have other risk factors for stroke or a heart attack.
———————————————————————

EVISTA is not right for everyone. Patients should not take EVISTA if they:

— have had blood clots in their legs, lungs or eyes.
— are pregnant, nursing or may become pregnant, as EVISTA may cause fetal
harm.

What should patients tell their doctor before taking EVISTA?

Patients should talk to their doctor about all their medical conditions
including:

— If they have had blood clots in their legs, lungs or eyes.
— If they have had a stroke, mini-stroke, irregular heartbeat, high blood
pressure, heart attack, history of smoking, or think they have other
risk factors for stroke or heart attack.
— EVISTA should not be used for prevention of heart disease.
— If they are premenopausal. Patients should only take prescription EVISTA
if they are past menopause.
— If they have liver or kidney disease. Women with liver or kidney disease
should use EVISTA with caution.
— EVISTA should not be taken with estrogens in the form of pills, patches
or injections.
— If they have taken estrogen in the past and had a high increase of
triglycerides (a kind of fat in the blood).

What are the possible side effects of EVISTA?

— Side effects may include hot flashes, leg cramps, swelling, flu-like
symptoms, joint pain, and sweating. Patients are encouraged to report
negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.

What are the possible drug interactions with EVISTA?

— If patients take warfarin (Coumadin®, Jantoven®) or other coumarin blood
thinners, they may need to do a blood test (prothrombin time, pro-time
or INR) when they first start or if they need to stop taking EVISTA.
Their doctor may need to adjust the dose of their warfarin or other
coumarin blood thinners.
— EVISTA should not be taken with cholestyramine or estrogens.

For more information about EVISTA, please see the Full Prescribing Information
(http://pi.lilly.com/us/evista-pi.pdf) including Boxed Warning, and Medication
Guide (http://pi.lilly.com/us/evista-ppi.pdf).

RA Media ISI 01AUG2011

About Eli Lilly and Company

Eli Lilly and Company, a leading innovation-driven company, is developing a
growing portfolio of pharmaceutical products by applying the latest research
from its own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers — through medicines and information — for some of the world’s most
urgent medical needs. Information about Lilly is available at www.lilly.com.
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SOURCE Eli Lilly and Company