Lilly Commends Surgeon General's Report on Bone Health

Lilly Commends Surgeon General's Report on Bone Health
Medical Director likens bones to architecture, emphasizes prevention 


INDIANAPOLIS, Oct. 14  /PRNewswire-FirstCall/ -- Today the Surgeon General of
the United States of America released the office's first opinion on bone
health, emphasizing the importance of lifestyle choices in maintaining strong
bones.  As a manufacturer of innovative osteoporosis treatments, Eli Lilly and
Company commends the Surgeon General's foresight and dedication to addressing
the importance of maintaining healthy bones.

"Our bones are the fundamental architecture of our bodies.  Like bricks in a
building's foundation, if they crumble or fracture, the entire structure is
weakened and compromised," said K. Shaw Lamberson, MD, Medical Director of
Lilly's Women's Health & Reproductive Medicine Division.

But unlike actual architecture, bones constantly rebuild themselves, which is
why taking care of them is so important -- bones are living tissue, constantly
going through a cycle of regeneration.  By doing regular, weight- bearing
exercise and getting enough calcium and vitamin D, you increase the likelihood
that your bones will remain strong for a lifetime.

More than 50 percent of all women over the age of 75 are estimated to have
osteoporosis, and due to their advanced age, have a high risk for fracture. In
fact, most American women over the age of 50 will experience one or more
osteoporosis related fractures during their lifetime.

"Awareness is one of the key artillery we have to battle osteoporosis. This is
an exciting day for those who have fought to raise awareness and find solutions
to this often silent disease," said Lamberson.  "The Surgeon General has given
the public this great resource, and now it's up to the public to take the steps
necessary to protect their body's structural integrity by focusing on
prevention."

Lilly's osteoporosis unit provides a continuum of care for the disease, the
only pharmaceutical company to manufacture medicines that uniquely treat the
disease in each of its stages.  Lilly manufactures two osteoporosis
medications:

EVISTA(R) (raloxifene HCl), the first SERM (Selective Estrogen Receptor
Modulator) approved for use in preventing and treating osteoporosis in
postmenopausal women, and FORTEO(R) (teriparatide [rDNA origin] injection) the
first and only bone formation agent approved for the treatment of osteoporosis
in postmenopausal women who are at high risk for fracture, and to increase bone
mass in men with primary or hypogonadal osteoporosis who are at high risk for
fracture.  These include men (and postmenopausal women) with a history of
osteoporosis-related fracture, or who have multiple risk factors for fracture,
or who have failed or are intolerant to previous osteoporosis therapy based on
physician assessment.

Important Safety Information about EVISTA

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 should not 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.  The most commonly reported side effects were hot flashes
and leg cramps.  Side effects with EVISTA have usually been mild, and most
women didn't find them serious enough to stop taking it.

You may be at increased risk for osteoporosis if you are Caucasian (white) or
Asian, have a slender build, don't exercise, or have a family history of the
disease.  If you don't get enough calcium and/or vitamin D in your diet, you
should also take these supplements.  For full prescribing information, please
visit http://www.evista.com/

Important Safety Information about FORTEO

In two-year studies in rats, teriparatide caused an increase in the incidence
of osteosarcoma, a malignant bone tumor, which was dependent on dose and
duration of treatment.  Although no case of osteosarcoma has been reported in
the patients who received FORTEO in clinical trials, it is not known if humans
treated with FORTEO are at increased risk for this cancer.

FORTEO should be prescribed only to patients for whom the potential benefits
are considered to outweigh the potential risk.  The drug should not be
prescribed for patients at increased baseline risk for osteosarcoma, including
patients with Paget's disease of bone or unexplained elevations of alkaline
phosphatase, children or growing adults, or those who have had prior external
beam or implant radiation therapy involving the skeleton. Additionally,
patients with bone metastases or a history of skeletal malignancies, and those
with metabolic bone diseases other than osteoporosis, should not receive
FORTEO.  Patients with high levels of calcium in their blood should not receive
FORTEO due to the possibility of increasing their blood levels of calcium.

In clinical trials, the most frequent treatment-related adverse events reported
at the 20-microgram (mcg) dose approved for marketing were mild, similar to
placebo and generally did not require discontinuation of therapy. Reported
adverse events that appeared to be increased by FORTEO treatment were leg
cramps and dizziness (2.6 and 8 percent, respectively), compared with placebo
(1.3 percent and 5.4 percent, respectively).

FORTEO is supplied in a disposable pen device that can be used for up to 28
days to give once-daily self-administered injections.  FORTEO is available in a
20-mcg dose and should be taken for a period of up to 24 months.  Lilly has
implemented a risk management program that includes comprehensive measures
regarding the appropriate use of FORTEO in the target patient population.  A
Medication Guide explaining the details of the drug to the patient also
accompanies the product.  FORTEO also has a black box warning in its package
insert about the osteosarcoma findings in rats during preclinical testing. For
full prescribing information, please visit http://www.forteo.com/ .

About Osteoporosis

More than 50 percent of all women over the age of 75 are estimated to have
osteoporosis, and due to their advanced age, have a high risk of fracture.  In
fact, most American women over the age of 50 will experience one or more
osteoporosis-related fractures during their lifetimes, and women with
osteoporosis who have two or more previous fractures have up to a nine times
greater risk of future fracture compared with women who have not suffered a
previous fracture.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class, 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/ .

  Evista(R) (raloxifene hydrochloride, Lilly)
  Forteo(TM) (teriparatide [rDNA origin] injection, Lilly)

  (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, [phone],

Email:  



Web site:  http://www.lilly.com/ 

Copyright