Andy, AP is carrying a story on anti-estrogens for osteoporosis. Most advanced is LLY's raloxifene (Evista) which has been widely covered (CNBC, WSJ).
PFE's Droloxifene is mentioned (LGND gets royalties for ALL indications if its approved for more that breast cancer) as id AHP's Premarin (LGND has major women's health program with AHP for many indications, including tissue selective estrogens and progestins for osteoporosis):
.c The Associated Press
NEW YORK (AP) - Barbara Zimmerman stumbled off a New Jersey curb and into a
race between drug makers dashing to be the first to replace the most widely
prescribed drug in the nation: estrogen.
While nursing her broken ankle, the retired jewelry designer discovered she
had osteoporosis. But she balked at taking estrogen - the conventional
treatment for the bone-thinning disease - when her doctor warned it could
raise her risk of breast cancer.
``We have a lot of cancer in our family and I was afraid to take estrogen,''
said Mrs. Zimmerman, 70, of Tenafly, N.J. ``It was just scary to me.''
Instead, two years after her fall, Mrs. Zimmerman is wrapping up her stint as
a research subject in a blind test of Eli Lilly's drug, raloxifene, willing
to take the risk that she's in the control group that gets plain calcium
supplements. Researchers expect the drug to be the first estrogen replacement
on the market. It would be given instead of estrogen for women who have gone
through menopause.
If these new drugs work, women would be able to protect their bones and
hearts without increasing their chances of breast cancer. With women living
longer and baby boomers just starting to take post-menopausal drugs, the
potential market is immense.
``For any drug which shows itself to be effective for treatment of
osteoporosis, the market is billions of dollars,'' said Hemant Shah, a
pharmaceutical industry analyst in Warren, N.J.
Lilly's version, trade-named Evista, could be approved by the end of the year
for osteoporosis. But competitors are following close behind. Pfizer Inc.'s
droloxifene is being tested against osteoporosis. British companies Glaxo
Wellcome PLC, SmithKline Beecham PLC and Zeneca PLC all have their own
compounds in the works.
Estrogen is a natural reproductive hormone that helps keep women's hearts and
bones strong, but the body stops making it at menopause. So women take
estrogen supplements to avoid hot flashes during menopause. And after
menopause, many women take estrogen to prevent heart disease and
osteoporosis. New studies suggest estrogen may also help prevent Alzheimer's
disease.
Wyeth-Ayerst Laboratories' estrogen drug Premarin, made from horse urine, is
the most widely prescribed drug in the nation, with sales of nearly $1
billion last year.
The new drugs don't quite make Premarin obsolete, Shah said.
``Premarin is going to be indispensable for women with hot flashes, and most
women have hot flashes with post-menopausal symptoms,'' he said. ``These
drugs don't treat that.''
Doctors usually combine estrogen with progestin, which researchers say
reduces the breast cancer risk and virtually eliminates the increased risk of
uterine cancer. But only about 20 percent of post-menopausal women who could
benefit from estrogen's heart and bone protection take the hormone, in part
because many fear the link to breast cancer.
The new class of drugs may even prevent breast and uterine cancer by blocking
estrogen from acting on those tissues. A study published in the June issue of
the New England Journal of Medicine suggested that for women with a high risk
of heart disease, long-term use of estrogen may be worthwhile, but for women
with an elevated risk of breast cancer, the benefits are less clear.
Women who take estrogen after menopause significantly cut their risk of death
for about a decade, but then the benefits diminish because the risk of breast
cancer gradually increases by nearly 50 percent after 10 years of estrogen
use, the study found.
The anti-estrogens were designed to block estrogen, but later studies showed
they also mimic the hormone in bones and other tissues. That has researchers
trying to make the estrogen blockers into estrogen replacements.
Lilly and Glaxo say studies suggest anti-estrogens are effective at
increasing bone mass and preventing heart disease. But many researchers
remain skeptical, saying the information the companies have released is
limited and covers only a short period of time.
``The data on raloxifene, hopefully, is there, but most of us have not seen
the data,'' said Dr. Roger Blumenthal, director of preventive cardiology at
Johns Hopkins Hospital in Baltimore.
And Dr. Trudy Bush, an epidemiologist at the University of Maryland Medical
Center in Baltimore, noted that the new anti-estrogens are related to the
cancer-fighting drug tamoxifen. That drug combats breast tumors, but
longer-term studies showed it can also cause uterine cancer.
Lilly clinical research director Dr. Willard H. Dere said that raloxifene is
a different compound and that the company will closely follow the women once
the drug is approved.
Mrs. Zimmerman, said the trial at New York's Columbia-Presbyterian Medical
Center has apparently helped.
``I can't say that I'm on it, but the first year there was a 5 percent
increase in the bone density,'' she said. ``I think it's a great
alternative.''
AP-NY-09-25-97 2002EDT |
