Pfizer's Viagra Impotence Treatment Receives Initial Approval in Japan
Tokyo, Dec. 21 (Bloomberg) -- Viagra, the impotence pill,
could be available in Japan from next month after the Health and
Welfare Ministry said it gave its initial approval, suggesting a
jump in earnings next year for maker Pfizer Inc., the fourth
biggest U.S. drugmaker.
The thumbs-up from a panel of Japan's Ministry of Health and
Welfare means the ministry will almost certainly give Viagra its
full backing, possibly by Thursday, analysts said. Viagra would
become available around a month later, about the end of January,
they said.
In the U.S. Viagra was the most successful drug introduction
ever, with sales of $411 million in the second quarter, or the
three months after it was introduced in April. Sales fell to $141
million in the third quarter as global media hype subsided, but
could still approach $1 billion in its first year.
Viagra probably won't be as successful in Japan, said Kenji
Masuzoe, a pharmaceutical analyst at Deutsche Securities Ltd.
That's because of government restrictions on drug advertising and
because Japanese might be more embarrassed about asking for
medical assistance, he said.
''In American society, (impotence) is recognized as a
disease which interferes with quality of life, but in the
Japanese sense, it's not really a disease,'' he said. ''Doctors
will have to conduct a thorough consultation to prove a patient
is suffering.''
For legal reasons the Japanese subsidiary Pfizer
Pharmaceutical Inc. declined to comment on projected sales in
Japan.
''It's prohibited to advertise unapproved drugs. We are sure
you have details you want to confirm with us, but we can't answer
these questions because it's against the law,'' said Koichi
Hirota, a Pfizer Pharmaceuticals spokesman, in a statement.
Pfizer Pharmaceutical has boosted medical representatives to
more than 1,000 in Japan, Masuzoe said.
Market Growth
The global market for impotence drugs could grow to $4
billion a year as new drugs are introduced, analysts said. Astra
AB, Sweden's no. 1 drugmaker said Friday before last that it won
approval for an impotence treatment called Muse, a pellet that's
inserted into the urethra at the head of the penis. Viagra is
taken orally.
Older treatments include Pharmacia & Upjohn Inc.'s
Caverject, which is injected by syringe into the penis. Other
companies, including Zonagen Inc., PowderJect Pharmaceuticals Plc
and MacroChem Corp. are developing treatments for impotence.
Between 1 million and 5 million men in Japan are thought to
be impotent, said Masuzoe. More than 50 percent of Japanese men
over 56 years old are impotent, according to research presented
at a media briefing organized by the health ministry. 30 percent
of male sterility is caused by erectile dysfunction, the research
showed.
The drug won't be available in Japan over-the-counter
because of concern about side effects, particularly in patients
at risk of a heart attack. The Health Ministry plans to publish a
handbook for doctors and information on side effects for
patients.
As of mid-November, the U.S. Food and Drug Administration
had confirmed at least 130 reports of deaths among U.S. patients
who had taken Viagra, according to Lisa Rarick, director of the
division that oversees reproductive and urological products.
By comparison, about 1.1 million Americans suffer some form
of coronary heart attack every year, and about a third of them
will die, according to the American Heart Association.
In the nine months to November, doctors in the U.S. wrote
more than 6 million prescriptions of Viagra, according to the
Ministry of Health and Welfare.
Pfizer was the 4th largest drugmaker in the U.S. by 1997
sales, according to IMS Health Inc. New York-based Pfizer also
makes the high blood pressure drug Norvasc and the anti-
depressant Zoloft
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