FDA Approves Lilly's Osteoporosis Drug EVISTA(R) To Reduce The Risk Of Invasive Breast Cancer In Two Populations Of Postmenopausal Women

Eli Lilly and
Company (NYSE: LLY) announced that the U.S. Food and Drug Administration
(FDA) has approved its osteoporosis drug EVISTA(R) (raloxifene HCl) for a
new use to reduce the risk of invasive breast cancer in two populations:
postmenopausal women with osteoporosis and postmenopausal women at high
risk for invasive breast cancer.



"The FDA's decision marks a major milestone. For the first time,
postmenopausal women with osteoporosis will have one treatment option that
can help address two leading health concerns -- osteoporosis and invasive
breast cancer," said Gwen Krivi, Ph.D., vice president of Lilly Research
Laboratories. "Further, postmenopausal women at high risk for invasive
breast cancer will have an alternative therapy for invasive breast cancer
risk reduction."



EVISTA, a selective estrogen receptor modulator or SERM (recently
classified by the FDA as an estrogen agonist/antagonist), is already
approved for the prevention and treatment of osteoporosis in postmenopausal
women. In July, the Oncologic Drugs Advisory Committee (ODAC) to the FDA
voted to recommend approval for the new uses. Today's decision and the
positive recommendation from ODAC were based on data submitted in November
2006 in a new drug application (NDA), evaluating clinical results from
approximately 37,000 postmenopausal women that spanned nearly 10 years.




Earlier this year, the osteoporosis label for EVISTA was updated to
include safety information from the Raloxifene Use for The Heart (RUTH)
trial, which evaluated postmenopausal women with known or at increased risk
for coronary disease taking EVISTA. This trial found no increase in the
incidence of stroke, but an increase in the incidence of death due to
stroke.



Since the new label for EVISTA(R) (raloxifene HCl) includes new uses
and an expanded patient population, Lilly worked with the FDA to revise the
package insert, which will now include a boxed warning. The warning
highlights information already included in the Contraindications and
Warnings & Precautions sections of the prior label. It emphasizes that
women with an active or past history of venous thromboembolism should not
take EVISTA and that women at risk for stroke should receive EVISTA only
after evaluating the risk-benefit balance with their healthcare providers.



"Thousands of women each year are diagnosed with invasive breast
cancer," said Dr. Lawrence Wickerham, M.D., associate chairman of the
National Surgical Adjuvant Breast and Bowel Project (NSABP), and associate
professor of human oncology at Drexel University School of Medicine.
"Today's approval of EVISTA for these new uses gives postmenopausal women
at risk for this disease an important new treatment option that allows them
to take a proactive approach to reducing their risk."
















While the exact causes of breast cancer are unknown, certain risk
factors are linked to the disease, including age, family history, personal
history of breast cancer, genetics and lifestyle factors(1). The increased
incidence of breast cancer as women age is notable, as nearly eight out of
10 breast cancers are found in women age 50 and older(2). The American
Cancer Society estimates that approximately 180,000 women are diagnosed
with invasive breast cancer each year(3).



In addition, age is an important risk factor associated with
osteoporosis. According to the National Osteoporosis Foundation,
approximately 55 percent of people affected by osteoporosis are age 50 and
over(4).



"As women age and enter the postmenopausal phase of their lives, the
incidence of certain diseases, such as invasive breast cancer and
osteoporosis, increases dramatically," said Steven Cummings, M.D., emeritus
professor of medicine and epidemiology and biostatistics at the University
of California San Francisco. "Therefore, it's important for postmenopausal
women to be aware of these serious risks and have treatment choices to
address them."



The FDA evaluated a data package that included multiple trials
assessing three different populations of postmenopausal women:



-- The Study of Tamoxifen and Raloxifene (STAR) trial, sponsored by the
National Cancer Institute (NCI) and coordinated by the National Surgical
Adjuvant Breast and Bowel Project (NSABP), involved postmenopausal women at
increased risk for invasive breast cancer. The observed incidence rates of
invasive breast cancer were EVISTA 4.4 and tamoxifen 4.3, per 1000 women
per year.



-- The Raloxifene Use for The Heart (RUTH) trial looked at
postmenopausal women with known or at increased risk for coronary disease.
The study demonstrated that EVISTA significantly reduced the risk of
invasive breast cancer in postmenopausal women by 44 percent with an
absolute risk reduction of 0.6 percent.



-- The Multiple Outcomes of Raloxifene Evaluation (MORE) and Continuing
Outcomes Relevant to Evista (CORE) trials evaluated postmenopausal women
with osteoporosis. Both four-year trials showed that EVISTA reduced the
risk of invasive breast cancer in women by 71 percent with an absolute risk
reduction of 1.1 percent, and 56 percent with an absolute risk reduction of
1.0 percent, respectively.



Important Safety Information About EVISTA(R)



EVISTA is not for everyone. If you are or still can become pregnant,
are nursing, or have had blood clots that required a doctor's treatment,
you cannot take EVISTA. An infrequent but serious side effect of EVISTA is
blood clots in the veins - being immobile for a long time may add to the
risk.



EVISTA does not increase or decrease the incidence of heart attack,
stroke, cardiovascular death, or overall death. In a study of
postmenopausal women at high risk for cardiovascular disease taking EVISTA,
there was no increase in the incidence of stroke; however, there was an
increase in the incidence of death due to stroke. If you have had a stroke
or have a history of other significant risk factors for stroke, such as a
mini-stroke (TIA/transient ischemic attack), hypertension, history of
cigarette smoking or a type of irregular heartbeat (atrial fibrillation),
you should discuss with your healthcare professional the risks versus
benefits of taking EVISTA.



If you have kidney or liver problems, you should discuss these
conditions with your healthcare professional before taking EVISTA.



The most commonly reported side effects are hot flashes, leg cramps,
peripheral edema, arthralgia, flu syndrome and sweating. Side effects with
EVISTA are usually mild, and most women don't find them serious enough to
stop taking it.



Important Limitations of Use for Breast Cancer Risk Reduction



EVISTA is indicated to reduce the risk of invasive breast cancer in
postmenopausal women with osteoporosis and postmenopausal women at high
risk for invasive breast cancer. The American Cancer Society estimates that
approximately 180,000 women are diagnosed with invasive breast cancer each
year(3).



EVISTA does not treat existing breast cancer, reduce the risk of
getting breast cancer again or reduce the risk of all forms of breast
cancer. For more information about EVISTA including prescribing information
and boxed warning, log on to evista



About Lilly



Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and 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, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs.
Additional information about Lilly is available at lilly.



P-LLY



Forward Looking Statement



This press release contains forward-looking statements about the safety
and efficacy of EVISTA and reflects Lilly's current beliefs. However, as
with any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization. There is
no guarantee that EVISTA will continue to be commercially successful. For
further discussion of these and other risks and uncertainties, see Lilly's
filings with the United States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.


References



1. American Cancer Society. What causes breast cancer? Accessed at
cancer/docroot/CRI/content/CRI_2_2_2X_What_causes_breast_cancer _5.asp?sitearea= on September 11, 2007.



2. American Cancer Society. Breast Cancer Facts & Figures 2005-2006.



3. American Cancer Society. How many women get breast cancer?



4. National Osteoporosis Foundation. Fast Fasts of Osteoporosis.
Accessed at nof/osteoporosis/diseasefacts.htm on September
11, 2007.


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