Lilly Statement on STAR
18 April 2006 - 5:15AM
PR Newswire (US)
INDIANAPOLIS, April 17 /PRNewswire-FirstCall/ -- Eli Lilly and
Company today issued the following statement in response to the
release of high-level results of the Study of Tamoxifen and
Raloxifene (STAR) trial, announced by the National Surgical
Adjuvant Breast and Bowel Project (NSABP). The trial was funded by
the National Cancer Institute (NCI) and conducted by researchers
with the NSABP. "The NSABP's STAR study represents an important
milestone in cancer research," said Steven Paul, M.D., executive
vice president of science and technology, Lilly. "We are pleased
with the STAR results, which add to the growing body of scientific
knowledge about the potential for therapies to reduce breast cancer
risk." The STAR data, coupled with data from the Raloxifene Use for
the Heart (RUTH) trial, represent important information, which
Lilly plans to use for a submission to the U.S. Food and Drug
Administration (FDA) in support of an indication for Evista(R)
(raloxifene HCl) for the reduction of invasive breast cancer risk
in postmenopausal women. Importantly, Evista is currently marketed
in the U.S. for the prevention and treatment of osteoporosis in
postmenopausal women. Raloxifene is not approved by the FDA for
preventing or reducing the risk of cardiovascular disease or
invasive breast cancer. RUTH is a multi-national, double-blind,
placebo-controlled study with primary endpoints of invasive breast
cancer risk and cardiovascular risk reduction. Lilly recently has
announced preliminary results from RUTH. Final results from that
study are being analyzed and will be presented later this year.
RUTH and STAR, combined with data from Multiple Outcomes of
Raloxifene Evaluation (MORE) and Continuing Outcomes Relevant to
Evista (CORE) would be included in a potential supplemental new
drug application filing package. Important Safety Information
EVISTA is not for everyone. If you are or still can become
pregnant, are nursing, have severe liver problems, 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), or a type of irregular heartbeat
(atrial fibrillation), you should discuss with your doctor or
healthcare professional the risks versus benefits of taking EVISTA.
The most commonly reported side effects are hot flashes and leg
cramps. Side effects with EVISTA are usually mild, and most women
don't find them serious enough to stop taking it. 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 http://www.lilly.com/. For
more information about Evista, log onto http://www.evista.com/. For
a copy of the NSABP's press materials, log onto
http://www.nsabp.pitt.edu/ For more information on Lilly's oncology
portfolio, log onto http://www.lillyoncology.com/ 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 research and commercialization.
There is no guarantee that Evista will be approved for the
reduction of breast cancer risk or that it 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. P-LLY (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Keri S. McGrath of Eli Lilly and
Company, +1-317-651-6001, Cell: +1-317-554-7928, Email:
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