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It’s Getting Tougher
Labopharm LabopharmGets Gets FDA FDA Okay Okay For For Once-Daily Tramadol (Ryzolt) --Finally Finally
December
December
31,
31,
2008:
2008:
12:03
12:03
PM
PM
ET
ET
To
To
say
say
Labopharm
Labopharm
Inc.'s
Inc.'s
(DDSS)
(DDSS)
first
first
U.S.
U.S.
drug
drug
approval
approval
followed
followed
a
a
long
long
and
and
winding
winding
road
road
would
would
be
be
an
an
understatement,
understatement,
but
but
the
the
tramadol
tramadol
saga
saga
with
with
the
the
U.S.
U.S.
FDA
FDA
is
is
finally
finally
over
over
and
and
investors
investors
aren't
aren't
dwelling
dwelling
on
on
the
the
past.
past.
Earlier
Earlier
Wednesday,
Wednesday,
the
the
Canadian
Canadian
specialty-pharma
specialty-pharma
company
company
announced
announced
that
that
the
the
FDA
FDA
approved
approved
its
its
once-daily
once-daily
formulation
formulation
of
of
painkiller
painkiller
tramadol,
tramadol,
named
named
Ryzolt.
Ryzolt.
Labopharm,
Labopharm,
which
which
has
has
been
been
public
public
for
for
12
12
years,
years,
went
went
through
through
hoops
hoops
to
to
get
get
the
the
drug
drug
approved,
approved,
having
having
to
to
redo
redo
trials,
trials,
construct
construct
new
new
statistical
statistical
analyses,
analyses,
and
and
even
even
engage
engage
the
the
U.S.
U.S.
regulator's
regulator's
formal
formal
dispute-resolution
dispute-resolution
process.
process.
It
It
expects
expects
marketing
marketing
partner
partner
Purdue
Purdue
Pharma
Pharma
to
to
launch
launch
the
the
product
product
in
in
the
the
second
second
quarter.
quarter.
"This
"This
is
is
a
a
great
great
milestone
milestone
for
for
the
the
company
company
and
and
fantastic
fantastic
news
news
for
for
investors,
investors,
but
but
this
this
approval
approval
has
has
been
been
a
a
long
long
time
time
coming,"
coming,"
said
said
a
a
biotech
biotech
observer
observer
familiar
familiar
with
with
the
the
company.
company.
"I
"I
can't
can't
help
help
but
but
believe
believe
the
the
opportunity
opportunity
today
today
is
is
much
much
smaller
smaller
than
than
it
it
was
was
a
a
few
few
years
years
ago.
ago.
The
The
results
results
will
will
be
be
apparent
apparent
enough
enough
once
once
the
the
company
company
launches
launches
the
the
drug."
drug."
…
In
In
the
the
U.S.,
U.S.,
Ryzolt
Ryzolt
will
will
face
face
competition
competition
from
from
Biovail
Biovail
Corp.'s
Corp.'s
Ultram
Ultram
ER,
ER,
which
which
has
has
a
a
three-year
three-year
head
head
start
start
and
and
is
is
backed
backed
by
by
marketing
marketing
juggernaut
juggernaut
Johnson
Johnson
&
Johnson.
Johnson.
Despite
Despite
the
the
lead
lead
and
and
having
having
the
the
market
market
to
to
itself,
itself,
the
the
drug's
drug's
sales
sales
have
have
been
been
a
a
disappointment
disappointment
to
to
investors.
investors.
In
In
2007,
2007,
Biovail's
Biovail's
revenue
revenue
from
from
Ultram
Ultram
ER
ER
was
was
$86.7
$86.7
million;
million;
through
through
the
the
third
third
quarter
quarter
of
of
2008,
2008,
revenue
revenue
was
was
$
$
64.1
64.1
million.
million.
13
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© Defined Health, 2009
Pain Insight Briefing