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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 Marketing would would be be an an partner understatement, understatement, Purdue but but Pharma the the tramadol tramadol plans saga saga to with with launch the the U.S. U.S. in FDA FDA Q2 is is 2009. 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 "This
its its is
once-daily once-daily a great
formulation formulation milestone
of of for
painkiller painkiller the company
tramadol, tramadol, named named and
Ryzolt. Ryzolt. fantastic
Labopharm, Labopharm, news for
which which
has
has
been investors, been
public
public
for
for but 12
12
years, this years, approval went
went
through
through has hoops
hoops been to
to
get
get a the long the
drug
drug time approved,
approved, coming," having
having said to
to
redo
redo a
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
disputedisputeresolutionresolution
biotech process. process. observer familiar with the company. "I can't help but believe
It
It
expects
expects the opportunity marketing
marketing
partner
partner today Purdue
Purdue is much Pharma
Pharma smaller to
to
launch
launch than the
the
product it product was in
in a the
the few second
second years quarter.
quarter. ago.
"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 The
been
been results
a
a
long
long
time
time will
coming,"
coming," be apparent
said
said
a
a
biotech
biotech enough
observer
observer once
familiar
familiar the company
with
with
the
the
company.
company. launches
"I
"I the
can't can't drug." 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. Ryzolt investors. will In
In
2007, face 2007,
Biovail's
Biovail's competition revenue
revenue from from
Ultram
Ultram Biovail ER
ER
was Corp.'s was
$86.7
$86.7 Ultram million;
million;
through
through ER, which the
the
third
third has
quarter quarter of of 2008, 2008, revenue revenue was was $ $ 64.1 64.1 million. million.
14
To say Labopharm Inc.'s (DDSS) first U.S. drug approval followed a
long and winding road would be an understatement…Ryzolt, a QD
tramadol ER for moderately severe chronic pain, first received an
approvable letter from the FDA in 2006 – not data related. Since
then, Labopharm has filed a formal dispute resolution with the FDA.
a three-year head start and is backed by marketing juggernaut
Johnson & Johnson.
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Pain Insight Briefing