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',lin •11104

ly 20 years of research, making it
an unattractive gamble for large
multinationals, Teva decided to
go for it. Since the patent had ex-
pired, Teva justified its plans by
getting the FDA to grant Copax-
one orphan-drug status.
The FDA grants the status to
companies developing drugs to
treat diseases that affect less than
200,000 people in the U.S. Such
status ensures companies that
the FDA will not issue approval
for another such drug for seven
years and thus encourages drug
makers to invest in costly re-
search.
While the institute's prelimi-
nary studies proved promising,
Teva had to spend the next five
years upscaling the production
process in order to transform it
from a laboratory project to a
product geared for industrial-lev-
el production.
In 1991, the company pro-
ceeded to phase III clinical trials,
the last phase before FDA review.
This phase involved 251 early-
stage MS patients who were split
into two groups. One group of 125
subjects received a placebo, while
the second group received the Co-
paxone treatment. Up until this
point and throughout the phase
III study, researchers at Teva
were "just playing a game," said
Dr. Aaron Schwartz, head of
Teva's Copaxone division. 'There
are just so many different ways
you can fail."
But in July 1994, the Copax-
one game got serious. Upon re-
viewing the findings, Schwartz's
team realized that the drug had
a positive effect on the degree of
disability the patients had suf-
fered and had reduced the relapse
rate by 30 percent, a statistic that
was significant.
"With this drug, the primary
end point is the reduction of re-
lapses," explained Dr. Schwartz.

"But with this drug, the placebo
effect is huge and the drug has to
overcome both the placebo and
real effect."
The company began compiling
the 70,000 pages worth of stud-
ies, research and statistics need-
ed to register with the FDA for
review. In retrospect, company
heads say the process of obtain-
ing the FDA's approval was short
and easy. But Teva, which has in-
vested $100 million in Copaxone's
development, experienced many
ups and downs in the 11 months
before the company received the
FDA green light.
The most serious disappoint-
ment occurred when the FDA un-
expectedly and without
explanation reneged in July on
its decision to let the company by-
pass the peripheral and central
nervous system advisory panel's
review procedure.
Although the FDA's original
decision was exceptional, when it
rescinded, Wall Street got ner-
vous and Teva's Nasdaq-traded
stock dropped 9.25 percent.
"It's frustrating when the mar-
ket doesn't evaluate you right,"
said Dan Suesskind, Teva's CFO.
"The surprising thing was when
the FDA told us we could bypass
the hearing, not when they called
us before the committee."
But investors' faith soon re-
turned. In early September, in-
vestor optimism sent the stock up
30 percent and following the ad-
visory panel's ruling on Sept. 19,
the stock jumped another 8 per-
cent to $47. Since then, the stock
has fallen off slightly, closing re-
cently at $43.
Despite the slight drop, no one
is denying the overwhelmingly
positive impact the FDA's ap-
proval will have on the company's
future.
Although Teva's main bread
and butter will continue to come

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