Bloomberg: Pfizer's Viagra Wins European Union Approval (Update1)
Bloomberg News
September 15, 1998, 6:51 a.m. ET
Pfizer's Viagra Wins European Union Approval (Update1)
(Adds analyst's comment in 4th paragraph, background
throughout, updates share price reaction in last paragraph.)
Zurich, Sept. 15 (Bloomberg) -- Pfizer Inc.'s Viagra
received approval for sale in the 15-nation European Union, a
step toward reviving the impotence drug's flagging sales growth
after a record-breaking U.S. launch in April.
Individual EU governments will determine when Viagra will
be available and whether the costs will be reimbursed under
national health-care plans, Jochen Kubosch, spokesman for EU
Industry Commissioner Martin Bangemann, said yesterday.
Pfizer has said it plans to start selling the drug in some
EU countries next month, after Switzerland cleared Viagra in
June. The value of European sales will depend on whether
national health services agree to meet the costs, analysts said.
''The key in Europe is going to be reimbursement,'' said
independent analyst Hemant Shah, before the announcement.
The EU approval comes after U.S. prescriptions for the drug
fell to about 168,000 a week after topping 250,000 in June,
according to IMS Health Inc. Viagra's U.S. introduction was the
most lucrative for any drug, generating $411 million in sales in
its first three months.
''The approval again confirms the safety and efficacy of
the treatment,'' Pfizer AG said in a statement. Pfizer is the
world's sixth-biggest pharmaceuticals company.
Who Pays?
In the U.S., insurance companies finance their customers'
use of Viagra, though some limit their payments for the
impotence treatment, which can cost about $10 a pill. In Europe,
that may be different. U.K. Health Secretary Frank Dobson
yesterday temporarily barred doctors from prescribing Viagra as
a National Health Service-funded treatment, saying subsidizing
the drug ''could prove a serious drain on the funds of the
NHS.''
Dobson said the interim U.K. ban will be in effect until
ministers consult further with advisers and the manufacturer. In
the meantime, doctors will be allowed to prescribe the drug to
patients paying with their own funds.
In Switzerland, Pfizer has asked the Social Security office
to add the drug to a list of treatments covered by health
insurance, though the government has yet to rule on the request.
Interior and Health Minister Ruth Dreifuss has already said
she'd oppose such a move.
Still, Pfizer sold 15,000 pills in the first month since
Viagra's introduction in Switzerland, the most successful drug
launch in the country's history.
The EU's committee on medicines recommended in August that
the European Commission, the EU's final screening body for
pharmaceutical products, approve Viagra.
The EU comprises Austria, Belgium, Denmark, Finland,
France, Germany, Greece, Italy, Ireland, Luxembourg, the
Netherlands, Portugal, Spain, the U.K. and Sweden. The union has
a population of over 373 million.
Potential Users
Researchers have found that as many as 50 percent of men
between 40 and 70 years of age may suffer from erectile
dysfunction, and up to 10 percent may be completely impotent.
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 a treatment that must be delivered through the
urethra. Zonagen Inc. and TAP Holdings Inc., a venture of Abbott
Laboratories and Takeda Chemical Industries Ltd., are also
developing oral medications to treat impotence.
Pfizer's shares traded in Switzerland today rose 1.25
francs to 145 Swiss francs ($101.5)
--Rudy Ruitenberg in the Amsterdam bureau (31-20) 589 8507 and |
