Pfizer's Viagra Moves Closer to EU Sales in October (Update4)
(Adds shareholder comment in 4th and 6th paragraphs, details
on reimbursement in 7th paragraph, updates share price.)
Bloomberg News
August 25, 1998, 12:13 p.m. ET
Pfizer's Viagra Moves Closer to EU Sales in October (Update4)
Brussels, Aug. 25 (Bloomberg) -- Pfizer Inc. moved a step
closer to the expected October introduction of its impotence
pill, Viagra, in the 15-nation European Union by winning the
support of a key medical committee.
Pfizer could get the final approval needed from the European
Commission in mid-September. The European Union's committee on
medicines has recommended the commission approve the drug.
With $411 million in sales in its first three months on the
market, Viagra has had the most-successful introduction ever for
a new drug. Analysts have found it difficult to estimate what
Viagra's annual sales will be. Although some of the pills sold in
the U.S. have wound up on the black market around the world,
European approval is expected to boost Viagra sales.
''The takeoff of this drug was much faster than people
expected,'' said Erik Anderson, portfolio manager with Sit
Investment Advisors, which holds about 630,400 Pfizer shares.
''People are still trying to figure out the market size.''
Pfizer rose 2 3/4 to 108 1/8 in midday trading. New York-
based Pfizer has risen 94 percent in the past year, spurred by
prospects for Viagra.
New Markets
Adding new markets will help because Viagra sales have
slowed from their early spectacular start, Anderson said. The
drug's success also likely will bring competition as rivals seek
out smaller biotechnology companies focused on impotence
research, such as Icos Corp., he said.
It's unclear whether Viagra sales in Europe will equal those
in the U.S., analysts said. Europe is the third-largest market
for Pfizer, behind the U.S. and Japan.
In the U.S., insurance companies pay for Viagra, although
some have set limits on the impotence treatment, which can cost
about $10 a pill.
In the European Union, each nation will set its own policy
on whether users are entitled to have the cost of Viagra met or
subsidized by the state, said Rolf Bass, who heads the European
Medicines Evaluation Agency's human drugs unit.
Pfizer intends to start Viagra sales while it asks
regulators to set reimbursement policies, said Andrew McCormick,
a company spokesman. It is too early to say whether the drug's
cost will be reimbursed, he said.
The European Union includes Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Italy, Ireland, Luxembourg, the
Netherlands, Portugal, Spain, Sweden and the U.K.
The EU panel asked for a clear label warning of the drug's
''undesirable side effects.''
Side Effects
Clinical studies showed patients using Viagra reported
impaired vision and headaches in greater frequency than could be
expected by people not using the drug.
The U.S. Food and Drug Administration also estimates that
the drug was taken by 69 patients in the U.S. who later died.
Many of those men, though, were taking heart drugs that are known
to produce dangerous effects when they interact with Viagra,
which are highlighted on the drug's label.
The FDA has said it hasn't found Viagra to be the direct
cause of death and both the agency and the company have
repeatedly said the drug is safe when used properly.
Some groups are asking for further studies on the drug.
Public Citizen, a Washington-based consumer watchdog group, last
week petitioned the FDA to convene an expert advisory panel to
review the drug, saying its dangers aren't fully understood.
Unlike most other new therapies, Viagra didn't pass before an FDA
panel before approval.
In Europe, there also were some concerns over Viagra's
safety, analysts said, since members of such panels usually
address their recommendations to the commission by mail.
Viagra received the backing of the European Medicines
Evaluation Agency, an expert panel that advises European
regulators on drug approvals, on May 29.
Part of Viagra's success stems from the fact that it's
easier to use than other impotence remedies on the market. Vivus
Inc. sells an impotence treatment that must be delivered through
the urethra. Zonagen Inc. and TAP Holdings Inc., a joint venture
of Abbott Laboratories and Takeda Chemical Industries Ltd., are
also developing oral medications to treat impotence.
--Marthe Fourcade in the Paris newsroom (331) 5365 5065 and Kerry
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