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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product

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To: vestor who wrote (1271)6/3/1999 7:02:00 AM
From: harkenman  Read Replies (1) of 1837
 
Japan oral contraceptives market $1 Billion year open to oral contraceptives. Huge opportunity!

Japan's Health Ministry Clears the Way
For the Approval of Birth-Control Pills

By YUMIKO ONO and ELYSE TANOUYE
Staff Reporters of THE WALL STREET JOURNAL

TOKYO -- The Japanese government, ending nine years of debate, cleared
the way for approval of the use of birth-control pills in Japan. A Health and
Welfare Ministry advisory panel said it would submit a recommendation to
allow the contraceptive.

The formal approval, expected later this month, will set off one of the biggest
drug-marketing battles ever as nine companies simultaneously launch their
oral-contraceptive products in Japan later this summer.

"It's like the Oklahoma land rush," said Mark Larsen, president of American
Home Products Corp.'s Asia-Pacific and Latin American Wyeth-Ayerst drug
business.

The companies will race to grab a piece of a potentially huge market,
variously estimated by analysts at $800 million to $1 billion a year. That
would breathe new life into a moribund product category with sluggish sales
growth of between 2% and 5% a year, said Hemant Shah, an independent
analyst. U.S. sales of oral contraceptives total about $1.2 billion a year, he
added.

Scramble by Drug Makers

The opportunity to open up one of the world's most lucrative markets for
birth-control pills is the reason nine companies -- including American Home,
Johnson & Johnson, Monsanto Co., and Akzo Nobel NV -- pushed to start the
debate to allow oral contraceptives in Japan when they applied to make oral
contraceptives nine years ago. The long debate covered everything from
concern the pill would encourage promiscuity to fear it would help spread
AIDS.

Criticism of the government reached a crescendo when the Health Ministry
approved the sexual-dysfunction drug Viagra in an unusually speedy six
months, while continuing to ponder its position on the birth-control pill.
Usually action is taken on a new-drug application within 18 months.

Japan's Minister of Health and Welfare is expected to formally approve the
advisory panel's decision by the end of this month and the drug may be
available to Japanese women before year end, said Toshiki Hirai, a ministry
spokesman. Prescriptions for the pill probably won't be covered by Japan's
national health-insurance plan, although the issue hasn't been decided, Mr.
Hirai said.

Market Size Unclear

Just how large the market for birth-control pills is in Japan is unclear. A
survey last year by the newspaper Mainichi Shimbun found just 7.2% of
women said they would use the pill if they could. That compares with 54.2%
who said they wouldn't want to use it. Those who shunned the pill cited
concerns such as the possible side effects, which can include nausea and
bleeding. Condoms are the most commonly used contraceptive in Japan.

Kenji Masuzoe, a Deutsche Securities analyst, said he expects the market to
"have a slow start," in part because of concerns over side effects. But
education programs by drug makers eventually could see the market grow to
about 100 billion yen ($830 million) in annual sales, he said.

One factor that could spur sales of the pill is that the rate of unplanned births
in Japan is twice that of the U.S. and about the same as Botswana, said a
spokeswoman at the Alan Guttmacher Institute, a reproductive research and
policy organization in New York. In fact, many women simply don't use
contraception in Japan: about 64% use some form of contraception compared
with 90% in the U.S. About half of Japanese couples use condoms or
withdrawal methods, she said. Abortion rates are said to be high in Japan, but
statistics are incomplete.

But American Home Products' Mr. Larsen said he thinks the sales growth of
oral contraceptives will be "evolutionary," because of the conservative nature
of Japan. "It will take some time to build this market," he predicted, adding
that total annual sales of contraceptives in Japan are likely to be about $400
million, much lower than some analysts' projections.
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