Zeneca Seeks Approval of Drug for Preventing Cancer
April 30, 1998, 10:28 a.m. PT
Washington, April 30 (Bloomberg) -- Zeneca Group Plc
submitted an application for U.S. regulatory approval of its
Nolvadex drug to prevent breast cancer.
Analysts and investors have been watching for the
application since a massive study released earlier this month
found the drug could prevent tumors in healthy women at high risk
for breast cancer.
The U.S. Food and Drug Administration has already said it
will give a quick review to the Zeneca drug, currently approved
for the treatment of breast cancer.
''The proposed use of Nolvadex to prevent the occurrence of
breast cancer represents a new frontier in women's health,'' said
Gerard Kennealey, vice president of medical affairs at Zeneca
Pharmaceuticals, a U.S. unit of the U.K.-based company.
Zeneca's American depositary receipts rose 1 3/4 to 43 1/2
in recent trading.
Earlier this month, researchers said they found the drug,
known generically as tamoxifen, could reduce the rate of breast
cancer in women prone to the disease by 45 percent compared with
high-risk women who took no drug.
The study was the first report that anything -- including
diet, lifestyle changes, or drugs -- has been proven to reduce
odds a woman will develop breast cancer. Unlike lung cancer,
where quitting smoking greatly changes the risk of later having
the disease, the causes of breast cancer remain largely unknown.
Analysts said approval for prevention of breast cancer could
boost Zeneca's $500 million annual sales for Nolvadex.
Risk of Uterine Cancer
Still, scientists aren't ready to give the drug a blanket
recommendation. There are some risks.
Overall, women taking tamoxifen in the NIH study had about
double the chance of developing cancer of the uterine lining and
about three times the risk of developing potentially life
threatening blood clots.
Barr Laboratories Inc. sells a generic version of tamoxifen,
which it ranks as its biggest selling drug. Shares of Pomona, New
York-based Barr fell 3/8 to 40 3/8 in recent trading.
Meanwhile, Eli Lilly & Co., Pfizer Inc., Novo Nordisk A/S
and SmithKline Beecham Plc are studying new drugs similar to
tamoxifen for their ability to prevent breast cancer. Preliminary
results for Lilly's Evista, currently approved for prevention of
osteoporosis, suggest the drug may prevent breast cancer without
increasing the risk of uterine cancer.
A full study of Lilly's Evista drug will be presented at an
American Society of Clinical Oncology meeting next month.
--Kristin Jensen in the Washington newsroom (202) 624-1843 with |
