Warner-Lambert May Seek OTC Clearance for Lipitor (Update1)
Bloomberg News
July 13, 1999, 4 p.m. ET
Warner-Lambert May Seek OTC Clearance for Lipitor (Update1)
(Adds closing share price.)
Morris Plains, New Jersey , July 13 (Bloomberg) -- Warner-
Lambert Co. said it is may pursue government approval to sell
Lipitor -- the most popular cholesterol-lowering drug in the U.S.
-- without a prescription.
A switch to over-the-counter status is ''something we are
looking at,'' although no decisions have been made, said Carol
Goodrich, a spokeswoman for Warner-Lambert. There is no timeline
for a potential move to OTC, said Goodrich, who declined to offer
further details.
Lipitor had worldwide sales of $2.2 billion in 1998, and
helped transform Warner-Lambert -- the maker of Listerine
mouthwash and Trident chewing gum -- into one of the world's most
successful drugmakers. Lipitor sales are expected to increase 50
percent to $3.3 billion in 1999.
Still, to move to an over-the-counter classification a
prescription drug needs the support of the U.S. Food and Drug
Administration. The agency hasn't yet shown an inclination to do
that for similar drugs, analysts said.
''The FDA has so far been very hostile to cholesterol-
lowering drugs,'' said Alex Zisson, an analyst with Hambrecht &
Quist.
The news was previously reported by the Newark Star-Ledger
following an interview with Warner-Lambert Chief Executive
Lodewijk de Vink.
Shares in Warner-Lambert rose 1 7/16 to 68 1/8.
In deciding switches to OTC, the FDA looks to see whether a
drug can be considered safe for use without a doctor's
supervision, and whether the condition being treated can be
managed without a doctor's consultation.
That may be the main hurdle for any company seeking to sell
a cholesterol drug over-the-counter. In 1997, a panel of FDA
advisers in a split vote declined to back an over-the-counter
transition for Questran, an older cholesterol drug made by
Bristol-Myers Squibb Co., because they were uncomfortable with
self-treatment for high cholesterol.
''Basically the FDA's advisers on this topic have been very
united on the view that cholesterol-reducing drugs require a
physician oversight,'' said Ira Loss, senior vice president of
Washington Analysis, an equities research firm that follows
regulatory actions. ''I remain highly skeptical that this is an
area where the FDA will allow products over-the-counter.''
Still, Warner-Lambert isn't the only company eyeing non-
prescription sales of a cholesterol drug. Merck & Co. said
earlier this year that it may seek OTC approval for a version of
its Mevacor cholesterol drug.
An OTC switch is one way for drugmakers to squeeze more
sales out of a drug, particularly those nearing the end of patent
protection, or medicines that treat conditions which may not
motivate people to visit a doctor, as was the case with Pharmacia
& Upjohn Inc.'s Rogaine solution for preventing hair loss.
In most cases, the drug is sold at a lower strength and
treats less serious conditions than when it's in full form.
With Lipitor's patent expiration date still far off in the
future, and with sales of the potent drug expected to reach $4
billion in 2000, it may seem premature to consider a move to over-
the-counter. However, if the FDA remains hesitant about
cholesterol drugs, Warner-Lambert may be wise to start now on
what could be a long road, Zisson said.
''You definitely have to start early,'' Zisson said.
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