Pfizer Tells FDA Panel Its Drug Can Treat Atrial Fibrillation
Bloomberg News
January 28, 1999, 2:02 p.m. ET
Bethesda, Maryland, Jan. 28 (Bloomberg) -- Pfizer Inc.
representatives told members of a U.S. government panel that the
company's Tikosyn drug can fight a potentially deadly heart
irregularity known as atrial fibrillation.
The backing of the U.S. Food and Drug Administration
advisory panel is crucial for Pfizer, the fourth largest U.S.
drugmaker, in its bid to win U.S. approval of Tikosyn. The panel
later will answer a series of detailed questions about the drug's
potential safety risks and whether it's better or worse than
older drugs used to treat the condition.
Pfizer representatives told the panel that the drug doesn't
pose any more risks than currently available therapies, such as
the generic drug quinidine. Tikosyn, also known as dofetilide,
can help patients retain normal heart rhythms, improving their
quality of life, they said.
''Our current therapeutic options are limited and all of
them are associated with measurable risk,'' said Jeremy Ruskin, a
researcher from Massachusetts General Hospital. Tikosyn ''would
provide a useful addition.''
Still, Tikosyn probably won't be a blockbuster if it's
approved and therefore won't have a major effect on Pfizer, which
reported revenue of $3.87 billion in the fourth quarter, they
said.
Analysts estimate Tikosyn could have peak annual sales of
between $300 million and $750 million if approved. More important
for Pfizer are sales of drugs such as its Viagra anti-impotence
pill and marketing agreements such as the one it has with
Monsanto Co. for the new painkiller Celebrex, analysts said.
''Commercially, and from an earnings standpoint, the co-
marketing of Celebrex is much more important for Pfizer,'' said
Richard Stover, an analyst with Arnhold & S. Bleichroeder.
Shares of New York-based Pfizer rose 1 3/4 to 123 11/16 in
midafternoon trading. Earlier, Pfizer announced plans to hold a
vote in April on splitting its stock 3-for-1.
Limited Options
Pfizer will be helped in its bid to win approval of Tikosyn
by the fact that there are limited options available for the
estimated 2.2 million Americans with atrial fibrillation,
analysts said. The company could face questions on safety,
however, because studies have suggested the drug can in some
cases actually cause a dangerous type of irregular heart rhythm.
During an open public hearing, Larry Sasich of the watchdog
group Public Citizen urged the panel to recommend against
approval of the drug.
Potential Risks
Sasich said his group is worried about the potential risks
of Tikosyn, especially given the history of anti-arrhythmic heart
drugs which have the potential to actually harm patients if not
used correctly. ''We do have serious concerns,'' he said.
Pfizer representatives showed the panel results of two major
studies involving about 1,100 atrial fibrillation patients with
varying analyses.
Under the best case scenario, Tikosyn brought about 30
percent of patients back into a normal heart rhythm compared to
only about 1 percent of patients given a placebo. This
''conversion'' is one use the panel will consider today.
The other use the panel will consider is ''maintenance,'' or
reducing the recurrence of the irregular rhythms. In its best-
case analyses, Pfizer found Tikosyn was able to keep between 58
and 66 percent of patients free of atrial fibrillation or so-
called atrial flutter for a year. That's compared to between 21
percent and 25 percent of patients given a placebo.
While Pfizer is considered a marketing powerhouse and has a
host of profitable drugs, it also has had two significant
setbacks at the FDA in recent years. Last year, the company
failed to win an expected approval for its Zeldox schizophrenia
drug. And in 1996, Pfizer stopped development of its tenidap drug
for rheumatoid arthritis after an FDA advisory panel rejected it.
If it wins final FDA approval for Tikosyn, Pfizer will face
competition from Cincinnati-based Procter & Gamble Co., the
largest U.S. marker of household products. The company, which is
trying to increase its presence in the pharmaceutical market,
filed for FDA approval of its azimilide drug in December.
P&G shares rose 1 9/16 to 87 7/8 in recent trading.
--Kristin Jensen in Bethesda, Maryland with reporting from
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