Pfizer's Impotence Drug Viagra Wins Japanese Approval (Update6)
Bloomberg News
January 25, 1999, 6:54 a.m. ET
Pfizer's Impotence Drug Viagra Wins Japanese Approval (Update6)
(Adds analyst's comment in 4th paragraph.)
Tokyo, Jan. 25 (Bloomberg) -- Pfizer Inc. said Viagra, its
impotence drug, won approval in Japan, paving the way for the
world's sixth-biggest drugmaker to sell the blockbuster treatment
in the world's second-largest economy.
Viagra, which generated $788 million in 1998 sales, could
get a substantial boost with the addition of Japan, which is also
the world's second-biggest pharmaceuticals market, analysts said.
They added that the drug's success may depend on marketing,
government reimbursement levels and social factors.
Viagra became the fastest-growing prescription drug in the
world after it was introduced last year in the U.S., Europe and
elsewhere to a wave of publicity not seen for any prescription
drug since Eli Lilly & Co.'s blockbuster depression drug Prozac.
''Theoretically it could be a $500 million-a-year drug in
Japan, but to some extent it will depend on whether Japanese men
will admit to needing any sort of help,'' said Paul Diggle, an
analyst with SG Securities in London.
Diggle said the drug's likely Japanese sales are ''hard to
call,'' since they also depend on reimbursement levels by
Japanese health authorities and the progress of health-care
reform there. For now, he said SG forecasts $250 million to $300
million in peak sales in Japan.
Leslie Patterson, president and chief executive of Pfizer's
Japanese division, said the company will ''invest heavily'' to
promote Viagra in Japan, the 54th nation to approve the drug.
''We are committed to an extensive education program in
Japan,'' said Patterson at a news conference. One key message
will be that impotence can indicate more serious problems, such
as diabetes and hypertension.
Japanese Market
Annual drug sales in Japan, at about $38 billion, represent
about 20 percent of total drug sales in major world markets and
make the country the world's second-biggest consumer of
pharmaceuticals, behind the U.S.
Viagra is the first medicine to be approved in Japan to
treat impotence, said Patterson.
Pfizer said it will start shipping Viagra to Japanese drug
wholesalers in one to two months. Patterson said some 7 million
prescriptions have been filled in the U.S. alone for Viagra after
it was approved early last year.
Alex Zisson, an analyst with Hambrecht & Quist, said
Viagra's sales in Japan will depend to some extent on social
factors.
''Viagra's ultimate potential still isn't clear in the U.S.
and Japan's social customs are different enough'' to make it
difficult to estimate sales there based on those in the U.S.,
Zisson said.
Potential Users
Kenji Masuzoe, an analyst with Deutsche Securities in Japan,
estimated that as many as 5 million Japanese men suffer from
impotence. More than 50 percent of Japanese men over 56 years old
are impotent, according to the Japanese health ministry.
However, Masuzoe said government restrictions on drug
advertising will probably keep Viagra from being as successful in
Japan as in the U.S. Japanese men also may be more embarrassed
about asking for medical assistance, he said last month when the
drug won preliminary approval in Japan.
''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.''
Pfizer said it will probably announce a Japanese Viagra
sales target next time it reports earnings. The company has
applied to Japan's health ministry for the cost of using the drug
to be reimbursed under the national health insurance program. In
the U.S., health insurance pays for 50 percent of the cost of
taking the drug.
The company hasn't yet set a price for Viagra in Japan.
Viagra More Convenient
The global market for impotence drugs could grow to $4
billion a year as new drugs are introduced to replace less
convenient treatments, analysts said.
Pharmacia & Upjohn Inc.'s Caverject, for example, is
injected by syringe into the penis. Other drugmakers such as Eli
Lilly & Co. intend to follow Pfizer and develop their own
impotence pills.
While Viagra has, by most accounts, been a huge success,
providing some benefit in about 70 percent of patients, it has
been plagued by reports of serious side effects.
According to the U.S. Food and Drug Administration, 130
people have died using the drug, although the agency maintains
the drug is safe when used according to prescribing rules. The
company particularly warns users of nitrate-based heart drugs
never to use Viagra.
Pfizer Pharmaceutical has increased the number of its
medical representatives in Japan to more than 1,000, Masuzoe
said.
--Kae Inoue in the Tokyo newsroom (813) 3201-8362 and Dane
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