CHICAGO (Reuters) -
Eli Lilly & Co (LLY.N) said on Friday
that it had won approval to market its blockbuster osteoporosis
drug to post-menopausal women who are at high risk for invasive
breast cancer.

The company also said U.S. health regulators had extended
the use of the drug, known as Evista, to help reduce the risk
of the aggressive form of breast cancer in post-menopausal
women who have the bone-thinning disease.

However, the drug will also contain a stronger warning of
side effects that can include death by stroke.

Evista, known generically as raloxifene, is already
approved for the prevention and treatment of osteoporosis, or
bone thinning, in post-menopausal women.

Lilly said Evista, like the hormone estrogen, helps to
fight osteoporosis. But Evista also blocks estrogen in breast
tissue, the drug maker said.

Sales of Evista, a selective estrogen receptor modulator,
topped $1 billion in 2006.

SERMs are drugs used to treat osteoporosis that also appear
to prevent breast cancer by reducing estrogen in breast tissue.
Estrogen in breast tissue can drive some types of breast
cancer.

“This data's been unfolding for the last few years, so it's
not as if physicians are not aware of this, but now Lilly will
be able to market it,” said Deutsche Bank analyst Barbara Ryan.

In 2007, Evista sales were flat with the prior year, she
noted. “Our view is that this (approval) may begin to deliver
some growth of maybe 10 to 20 percent,” she said.

That would equate to roughly $100 million to $200 million
in tadalafil alternative revenues annually. “But it doesn't brand tadalafil

move the needle at Lilly,” Ryan said. “So it's not momentous,
but we'll watch the scripts like everyone else, and maybe we'll
be surprised.”

Lilly, whose other products include tadalafil soft
Prozac
and erectile dysfunction drug Cialis, reported second-quarter
revenue of $4.63 billion.

Earlier this year, Lilly updated the label for Evista to
include safety information from a clinical trial that evaluated
post-menopausal women, some of whom were suffering from
coronary artery disease and some who were at increased risk for
coronary disease.

The trial found no increase in the incidence of stroke but
an increase in the incidence of death because of stroke.

Since the new label for Evista will include new uses and an
expanded patient population, Lilly has worked with the FDA to
revise the package insert. The insert will now emphasize that
women with an active or past history of venous generic tadalafil softtabs

– buy tadalafil cialis
deadly blood clots — should not take Evista and
that women at risk for stroke should receive the drug only
after careful evaluation.

A company spokeswoman said the so-called black-box warning
did not preclude the company from conducting direct-to-consumer
advertising.

The company presented studies of 37,000 women that compared
Evista with a placebo or tamoxifen, which has been used about
25 years to treat patients with advanced breast cancer.

Competing osteoporosis drugs include Merck & Co Inc's
(MRK.N) Fosamax, and Roche Holding AG's (ROG.VX) and
GlaxoSmithKline Plc's (GSK.L) Boniva.

Shares of Eli Lilly were down 33 cents at $56.85 in morning
New York Stock Exchange trade. Their price has ranged from
$51.13 to $60.63 during the past 52 weeks.

(Reporting by Debra Sherman)