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Ensuring Remoxy success
1. “Make
the
World
a
Be/er
Place”
Ensuring
REMOXY
Success
Timothy R. Roe!
82 Sherry Lane
Kensington, CT 06037
(860) 829-6688 Home
(860) 518-5571 Cell
t.roe@m2details.com Email
www.m2details.com Web Confiden'al
2. Contents
Page
3
Objec3ves
and
Limita3ons
6
About
the
Launch
9
Background
Informa3on
23
Compe33ve
Look
33
REMOXY
In
Vivo
44
Market
Development
and
Projec3ons
47
Strategic
Approach
61
Research
and
Backup
Slides
2
Confiden'al
4. ObjecCves
of
PresentaCon
• Thorough
understanding
of
the
marketplace,
REMOXY
and
the
commercial
environment
• Depict
ability
to
think
strategically
4
Confiden'al
5. LimitaCons
• Only
publically
available
informa3on
was
u3lized
• Some
data
could
not
be
adequately
referenced,
thus
valida3on
maybe
suspect.
• Some
public
informa3on
maybe
dated
or
inaccurate.
• Conclusions
or
plans
based
on
this
work
represents
only
one
strategic
direc3on
and
is
without
the
benefit
of
team
input
(Marke3ng,
Managed
Markets,
Tech
Ops,
Finance,
Medical,
Legal,
Regulatory
and
Compliance,
to
name
a
few).
• Time
–
The
deck
is
long.
I
will
breeze
through
some
parts
that
are
well-‐
understood.
Some
slides
are
incomplete
but
the
thought
process
is
present.
5
Confiden'al
7. One
Shot
To
Get
It
Right!!
• The
World
is
Watching…Wai3ng
• King
absolutely
needs
this
success
• Tireless
pre-‐launch
effort
• Address
Unmet
Needs
in
Opioid-‐
based
Pain
Management
• Not
an
incremental
step
toward
abuse-‐resistance
–
Must
ensure
percep3ons
are
managed
consistently
across
all
channels
and
targeted
segments
7
Confiden'al
8. REMOXY
“Making
the
World
a
Be1er
Place”
I'm Gonna Make A Change,!
For Once In My Life!
It's Gonna Feel Real Good,!
Gonna Make A Difference!
Gonna Make It Right . . .!
…I'm Starting With The Man
In!
The Mirror!
I'm Asking Him To Change!
His Ways!
And No Message Could
Have!
Been Any Clearer!
If You Wanna Make The
World!
A Better Place!
(If You Wanna Make The!
World A Better Place)!
Take A Look At Yourself,
And!
Then Make A Change!
8
Confiden'al
10. /
(The
Deal)
• Ini6al
Terms
– Big
upfront
–
$150
million
– Significant
milestones
–
up
to
$150
million
– Royal'es
15-‐20%
– King
to
fund,
but
PTI
to
control
development
through
Phase
II,
joint
control
through
Phase
III
• Complica6ons
– PTI
license
to
Durect
Technology
• King
to
meet
all
PTI
obliga'ons
to
Durect
(due
diligence,
etc.)
– Ini'al
Legal
Hurdles
• Limited
to
Durect
technology
applied
to
certain
opioids
• Possible
compe''on
from
other
Pain
(non-‐Durect)
products
• Considered
limited
“Right
of
First
Offer”
• CommercializaCon
Due
Diligence
– Agreed
on
detailed
ini3al
budget
for
King
– Couldn’t
agree
on
detailed
full
budget
at
3me
of
signing,
so
agreed
on
minimum
and
maximum
level
of
spending
over
several
years
with
JDC
to
determine
specifics
Source:
Wilson
Sonsini
Goodrich
&
Rosa3
Post-‐Contract
Presenta3on
10
Confiden'al
11. Chronic
Pain
Prevalence
• Up
to
56
million
American
adults
(28%
of
the
adult
popula3on)
experience
chronic
pain.
– 16
million
experience
low-‐back
pain
– 48
million
have
arthri3s—a
disease
associated
with
chronic
pain
– 25
million
have
migraine
pain
– 20
million
have
jaw
and
lower-‐facial
pain
– 4
million
have
neuropathic
pain
• Many
people
have
lived
with
pain
for
>5
years
and
experience
it
almost
six
days/week
• Younger
people
are
as
likely
to
experience
chronic
pain
as
are
older
people
• One-‐third
of
Americans
lose
20
hours
of
sleep
a
month
because
of
pain
Source:
PainBalance.org
(Funded
by
and
data
provided
by
King
Pharmaceu3cals)
11
Confiden'al
12. Burden
of
Moderate-‐Severe
Chronic
Pain
• Total
U.S.
direct
and
indirect
cost
of
chronic
pain
is
between
$50
&
$90
billion
per
year
– $4
billion
of
lost
income
and
produc3vity,
as
well
as
healthcare
costs,
associated
with
arthri3s
pain
– People
with
headache
pain
spend
$4
billion
on
medica3ons
according
to
a
2007
study
• Chronic
pain
is
associated
with
millions
of
days
of
lost
work
– Chronic
pain
brings
a
burden
of
depression,
anxiety,
frustra3on,
fa3gue,
isola3on,
and
lowered
self-‐esteem.
It
shaoers
produc3ve
lives.
– “Presenteeism”:
75%
of
the
lost
Produc3vity
is
due
to
Reduced
performance
while
on
the
job
–
not
work
absences.
– 25%
of
people
in
industrialized
countries
lose
work
because
of
chronic
pain
– People
with
low-‐back
pain
lose
93
million
days
of
work
according
to
a
2007
study
– People
with
headaches
and
migraine
headaches
lose
157
million
days
of
work
according
to
a
2007
study
• The
American
Board
of
Pain
Medicine
has
taken
the
lead
in
educa3ng
and
creden3aling
pain
medicine
specialists.
– So
far,
the
board
has
cer3fied
just
1,700
doctors
as
pain
specialists.
That's
about
one
pain
specialist
for
every
23,500
people
who
need
care.
– With
specialists
so
rare,
many
pa3ents
are
cared
for
by
doctors
who
lack
training
and
experience
in
the
appropriate
use
of
pain
therapies.
Source:
Chronic
Pain
Organiza3on
Web
Site
May
7,
2010
Stewart,
WF
et
al.
JAMA,
2003;290:2443-‐2454
PainBalance.org
(Funded
by
and
data
provided
by
King
Pharmaceu3cals)
12
Confiden'al
13. Under-‐Treatment
• Only
25%
of
those
suffering
from
chronic
pain
receive
appropriate
treatment
– Postopera3ve,
cancer,
and
chronic
pain
are
unlikely
to
be
treated
adequately
– Elderly,
children,
minori3es,
and
substance
abusers
are
unlikely
to
receive
adequate
pain
care
– Doctor
visits
for
pain-‐related
illnesses
were
the
primary
reason
for
66.16
million
visits—7.3%
of
all
visits—in
the
United
States
in
2003
– Drugs
for
the
relief
of
pain
were
prescribed
during
all
pa3ent
visits
more
oten
than
any
other
therapeu3c
class
• Reasons
for
Under-‐treatment
– Failure
of
healthcare
professionals
to
properly
assess
pain
– Pa3ent
factors
such
as
financial
barriers
and
poor
adherence
– Mispercep3ons
among
healthcare
professionals
about
the
consequences
of
opioid
use
– 40%
of
people
with
chronic
non-‐cancer
pain
are
not
currently
under
a
healthcare
professional’s
care
• Many
non-‐unified
pain
assessments
and
treatment
algorithms
Source:
PainBalance.org
(Funded
by
and
data
provided
by
King
Pharmaceu3cals)
13
Confiden'al
14. Major
Barriers
to
NarcoCc
Use
• PaCent
and
Physician
PercepCons
• Supply
Issues
– Ease
of
abuse
– FDA
– Addic3on
poten3al
• Stops
several
manufacturers
from
produc3on
un3l
passing
modern
approval
process
– Concern
of
stereotyping/s3gma
• Under
higher
scru3ny
ater
Cox-‐2
Crisis
–
more
• Physician
Issues
(Opiophobia)
stringent
rules
for
new
and
safer
drug
op3ons
– Rx
matching,
regulatory
scru3ny
– Pharmacy
Boolenecks
• Blame
distribu3on
issues
– Abuse
poten3al
– Distribu3on
System
– Subop3mal
knowledge
of
pain
and
poor
• Security
(Loss
Preven3on
&
Training)
assessment
tools
• Refrigera3on
requirements
– Fear
of
Robbery
• Short-‐dated
product
– PCPs
manage
50%
of
all
pa3ents
with
pain
• Manufacturer
supply
factors
– Pa3ent
non-‐compliance
with
script
• Cost
and
Coverage
– 50%
of
pa3ents
found
it
necessary
to
change
– Manufacturer
Price/Rebate
Structure
physicians,
primarily
because
of
inadequate
pain
management
– Independent
Insurance/Payer
Coverage,
Treatment
Protocols
&
Guidance
and
Tier
– Oten
relegated
for
terminally
ill
pa3ents
Structure
leaving
less
supply
for
others
– Addi3ve
cost
for
abuse
and
dependency
– Overdose
with
lethal
consequences
treatments
• The
number
of
fatal
poisonings
involving
opioid
analgesics
more
than
tripled
from
4,000
in
1999
– Diversion
and
Overseas
Counterfei3ng
to
13,800
in
2006,
according
to
the
Centers
for
Disease
Control
and
Preven3on
ly
Supp
ician
Phys
ns
ep3o
Perc Needs
Treatment
14
Confiden'al
15. FiZh
Vital
Sign
Pain
is
recognized
as
the
“Fith
Vital
Sign”
by
the
Joint
Commission
on
Accredita3on
of
Healthcare
Organiza3ons,
the
American
Pain
Society,
and
the
Veterans
Health
Administra3on.
Research
shows
that
when
pa3ent’s
acute
pain
is
managed
around
the
clock
and
the
pain
level
is
kept
from
becoming
severe,
the
total
amount
of
opioid
needed
is
reduced.
1.
Body
temperature
2.
Pulse
rate
(or
heart
rate)
3.
Blood
pressure
4.
Respiratory
rate
5.
Pain
15
Confiden'al
16. Failure
to
Adequately
Treat
and
Manage
Chronic
Pain
Tradi3onal
Approach:
Most
Chronic
Pain
PT
with
Unmanaged
cannot
be
treated
like
Chronic
Pain
acute
pain.
It
cannot
be
cured,
it
must
be
Healthcare
Costs
Rise,
managed.
Seen
by
PCP
or
MCO’s
Restrict
Access
Specialists
Further
In
a
2008
APS
study,
nearly
50%
of
PT
has
difficulty
pa3ents
found
it
necessary
to
change
func3oning
produc3vely,
Majority
Treated
Under
physicians
at
least
twice,
primarily
misses
work,
develops
Acute
Pain
Algorithms
because
of
inadequate
pain
secondary
depression
management.
70%
who
received
treatment
Seen
by
PCP
#2,
3…
Due
con3nued
to
report
pain.
To
Non-‐Relief
Modern
Approach:
Neurobehavioral
Model
Chronic
Pain
PCP/ • Assessed
Pain
Under
Control
PT
• Ini3al
Treatment
PT
Presenta3on
Spec
• Managed
for
Long-‐Term
Gallagher,
RM,
Med
Clin
Noth
Amer,
1999,
83
555-‐583;
Gallagher,
RM,
AmJ
Phys
Med
Rehab
2005,
B4
(Suppl)
s64-‐s76
16
Confiden'al
17. Opioids: Advantages and Disadvantages
• Advantages
– Effec3ve
against
moderate
to
severe
pain,
par3cularly
nocicep3ve
pain
– No
dose
ceiling
– No
end-‐organ
toxicity
• Disadvantages
– Poten3ally
addic3ve
Class
II
controlled
substances
• Pose
risk
of
abuse,
misuse,
and
diversion
– Dosage
limita3ons
due
to
side
effects—especially
cons3pa3on,
nausea,
and
somnolence—may
be
necessary
– Can
cause
respiratory
depression
and
should
be
used
with
cau3on
in
pa3ents
with
impaired
ven3la3on
Source:
PainBalance.org
(Funded
by
and
data
provided
by
King
Pharmaceu3cals)
17
Confiden'al
18. Side-‐Effects
of
Oxycodone
IM
Side
Bar
Worldwide
Produc3on
Growth
11.5
tons
in
1998
75.2
tons
in
2007
(U.S.
accounts
for
82%
or
51.6
tons
in
2007)
That’s
3
trucks
or
1
C-‐5
Galaxy
American
Society
of
Health-‐System
Pharmacists
(2009-‐03-‐23).
"Oxycodone".
U.S.
Na3onal
Library
of
Medicine,
MedlinePlus.
hop://www.nlm.nih.gov/medlineplus/druginfo/meds/a682132.html.
Retrieved
2009-‐03-‐27.
18
Confiden'al
19. Common
Opiate
Methods
of
Abuse
by
Brand
Source:
Budman
et
al.
Harm
Reduc3on
Journal
2009
6:8
19
Confiden'al
20. REMOXY
ADF
Crushed
REMOXY
Crushed
OxyCon3n
No
Rapid
Release
Euphoria
of
Oxycodone
20
Confiden'al
21. REMOXY
Design
• ORADUR
Technology
(SABER)
– Gel
cap
sustained
release
– Novel,
long-‐ac3ng
formula3on
– U3lizes
a
high-‐viscosity
base
for
controlled
release
of
ac3ve
over
12
to
24
hour
period
– Less
prone
to
abuse
– Manufactured
by
a
simple
process
using
conven3onal,
scalable
methods
– Lower
CoGS
than
most
compe33on
yields
higher
profit
margins
21
Confiden'al
22. REMOXY
as
a
Recognized
Name
“Pre-‐CommercializaCon”
22
Confiden'al
24. CompeCCon/OxyConCn
Approval
• The
new
formula3on
will
most
likely
result
in
less
abuse
by
inhaling
or
injec3on,
but
it
s3ll
can
be
“Hillbilly
Heroin”
abused
or
misused
by
inges3ng
larger
doses
than
are
recommended,
the
F.D.A.
said.
• With
the
previous
formula3on,
those
intent
on
abusing
the
drug
could
release
high
levels
of
oxycodone
all
at
once
by
tampering
with
the
pills.
• “Although
this
new
formula3on
of
OxyCon3n
may
provide
only
an
incremental
advantage
over
the
current
version
of
the
drug,
it
is
s3ll
a
step
in
the
right
direc3on,”
Bob
Rappaport,
the
F.D.A.’s
director
of
the
Division
of
Anesthesia
and
Analgesia
Products,
said
in
a
statement.
Approved:
April
5,
2010
24
Confiden'al
25. REMOXY
Needs
a
Respectable
Piece
of
The
Pie
50M
US
Chronic
Pain
Sufferers
25
Confiden'al
26. CompeCCve
Oxycodone
ERs
in
Development
Morphine
in
Phase
II,
Oxycodone
in
Phase
I
26
Confiden'al
30. CompeCCve
Oxycodone
ERs
in
Development
Resists
Typical
Methods
of
Abuse:
• When
crushed
or
ground
and
taken
orally,
releases
drug
comparably
to
INTELLITAB's
delivery
mechanisms
maintain
the
controlled-‐release
an
intact
tablet,
and
significantly
less
than
compe3ng
technologies
proper3es
of
a
drug
even
if
the
tablet
is
broken,
crushed
or
consumed
with
• When
crushed
or
ground
and
snorted,
releases
significantly
less
drug
alcohol.
Addi3onally
if
crushed
and
added
to
water,
alcohol
or
other
than
an
intact
tablet,
and
significantly
less
than
compe3ng
technologies
solvents,
form
a
solid
matrix
that
will
prevent
intravenous
injec3on
or
• When
crushed
or
ground,
cannot
be
injected
insuffla3on
(snor3ng).
• When
placed
in
alcohol,
will
not
dose
dump
30
Confiden'al
31. Other
ADFs
• OxyCon3n
–
oxycodone
CR
(Purdue)
– Not
permioed
to
market
the
tablet
as
tamper
resistant.
– New
tablet
will
be
marketed
as
a
switch-‐out
for
the
old
tablet
"so
both
will
not
be
sold,”
there
are
no
labeling
changes.
– Is
marginal
improvement
so
granted
approval.
• Acurox
–
oxycodone
IR
(Acura/King)
– “Among
the
weakest
and
most
fundamentally
flawed
of
the
ADF
formula3ons
currently
in
development.”
– ADF
defeated
with
325mg
Aspirin.
Niacin
flushing
will
simply
drive
pa3ents
to
other
physicians
the
Rx
of
a
non
ADF
IR
agent.
– Could
get
“ Tamper
Resistant”
label
resul3ng
in
a
marginal
improvement
and
be
approved
– Will
add
several
years
to
development
3meline.
Company
only
has
$33
million
cash.
31
Confiden'al
33. Watch
for
Transdermal
Opioids
• Delay
in
onset
of
plasma
levels
• Appears
to
be
efficient
route
for
chronic
pain
condi3ons
(Small
Compound
Molecule)
• Examples
• Fentanyl
(Duragesic,
IonSys)
• Sufentanil
(Endo,
In
Development)
• Buprenorphine
(Europe,
Australia)
• Hydromorphone
(Altea,
In
development)
Source:
Pamela
P.
Palmer,
MD
Professor
and
Director,
UCSF
PainCARE
Chief
Medical
Officer,
AcelRx
Pharmaceu3cals,
Inc.
33
Confiden'al
35. REMOXY
IN
VIVO
RESULTS
Summary
Four
robust
in
vivo
studies
have
shown
that
under
certain
physical
and
chemical
challenges
the
controlled-‐release
formula'on
of
REMOXY
is
not
defeated
and
that
these
challenges
do
not
result
in
a
rapid
release
or
dose
dumping
of
oxycodone.
Moreover,
a[er
mechanical
and/or
chemical
manipula'on,
the
rate
of
rise
of
oxycodone
plasma
concentra'ons
from
REMOXY
is
less
and
the
Tmax
is
longer
than
a[er
an
oral
oxycodone
solu'on
or
OxyCon'n.
The
a]rac'on
of
drugs
such
as
oxycodone
for
abuse
purposes
requires
an
effect
that
is
both
rapid
and
intense.
The
Abuse
Quo'ent
(AQ),
a
measure
of
a]rac'veness
of
a
formula'on
for
abuse,
for
REMOXY
a[er
physical
and/or
mechanical
manipula'on
remained
far
below
that
of
OxyCon'n
when
manipulated
in
a
similar
manner,
or
a[er
an
immediate
release
oral
solu'on
of
oxycodone.
The5
4
3
2
1
0REMOXY
+4%
EtOH
:
REMOXY
+
Water
REMOXY
+
20%
EtOH
:
REMOXY
+
Water
REMOXY
+
40%
EtOH
:
REMOXY
+
Water0
10
20
30
Subject57
of
60Cmax
Ra'oNDA
22-‐324
-‐
REMOXY®
Advisory
Commi]ee
BriefingAvailable
for
Public
Releasecombined
data
from
these
studies
suggest
that
REMOXY
a[er
certain
physical
and
chemical
challenges
may
offer
less
appeal
for
abuse
than
its
comparators.
(Detailed
Slides
in
Backup
Sec3on)
35
Confiden'al
40. REMOXY
In
Vivo
Results
1
• PTI-‐821-‐CZ
– The
controlled-‐release
mechanism
of
the
formula3on
was
not
defeated
ater
crushing
and
extrac3ng
with
40%
ethanol.
– Tmax
for
REMOXY
ater
tamper
was
significantly
greater
than
and
twice
as
long
as
that
of
OxyCon3n.
Cmax
– Although
the
rate
of
absorp3on
was
increased
ater
tamper,
it
remained
well
below
that
of
OxyCon3n
and
for
the
comparator
immediate
release
solu3on.
40
Confiden'al
41. REMOXY
In
Vivo
Results
2
• PTI-‐821-‐C04
– Early
Exposure
(AUC)
to
oxycodone
ater
chewing
REMOXY
was
much
lower
than
ater
an
oral
solu3on,
suppor3ng
the
premise
that
the
controlled
release
formula3on
was
maintained.
– A
decrease
in
Tmax
and
an
increase
in
Cmax
were
observed
ater
rigorous
chewing
of
REMOXY.
However,
the
data
indicated
that
the
controlled-‐release
mechanism
of
the
REMOXY
formula3on
was
not
defeated,
as
was
evident
from
the
lack
of
dose
dumping
and
plasma
concentra3on
profiles
which
retained
a
broad
plateau,
from
a
Tmax
which
remained
approximately
2.5-‐fold
longer
than
ater
an
oral
oxycodone
solu3on,
and
a
Cmax
which
was
lower
than
ater
an
oral
solu3on.
– The
data
taken
together
demonstrate
that
although
mas3ca3on
of
REMOXY
does
increase
the
rate
of
absorp3on
of
oxycodone
and
peak
exposure
compared
to
REMOXY
swallowed
whole,
it
does
not
approach
that
observed
with
an
immediate
release
oxycodone
oral
solu3on.
41
Confiden'al
42. REMOXY
In
Vivo
Results
3
• PTI-‐821-‐CU
– Results
from
this
study
show
that
buccal
administra3on
of
REMOXY
resulted
in
an
increase
in
the
rate
of
oxycodone
exposure,
but
one
that
was
much
lower
than
ater
an
oxycodone
oral
solu3on.
42
Confiden'al
43. REMOXY
In
Vivo
Results
4
• PTI-‐821-‐CS
– Ater
co-‐inges3on
of
REMOXY
with
ethanol
from
4-‐40%
the
plasma
concentra3on
profiles
were
similar
to
those
ater
inges3on
with
water
and
con3nued
to
display
typical
controlled
release
proper3es,
consistent
with
maintenance
of
the
controlled-‐release
characteris3cs
of
the
formula3on
and
without
any
evidence
of
dose
dumping.
– There
were
no
significant
effects
on
the
rate
or
extent
of
absorp3on
of
oxycodone
ater
administra3on
of
REMOXY
with
4%
or
20%
ethanol
and
overall
exposure
was
not
affected.
– There
was
a
minor
increase
in
Cmax
(10%)
and
exposure
ater
co-‐inges3on
with
40%
ethanol.
Tmax
was
not
affected
by
co-‐inges3on
of
REMOXY
with
ethanol
from
4-‐40%
43
Confiden'al
48. Strategy
Under
My
Tutelage:
Strategic Optimization Model PEQ322 Input Customer Data Here
The
strategic
plan
must
be
• Op3mized
• From
the
customer’s
perspec3ve
• Include
Posi3oning
Analysis
from
“R”
to
“2B”
• Non-‐issues
based
• Allow
for
tac3cal
curve-‐fi}ng
• Fully-‐developed
and
approved
48
Confiden'al
49. OpCmizaCon
An
op3mized
strategic
plan
is...
• Simply
a
roadmap.
It
tells
us
where
we
“R”
today
and
where
we
need
“2B”
in
the
minds
of
our
customers
in
order
to
meet
internal
objec3ves.
It
is
always
an
external
view,
never
internally
focused.
• Based
on
customer
(both
Rx’er
and
end-‐user)
percep3ons
at
3me
points
“R”
and
“2B”
• Customer
percep3ons
should
be
measured
across
several
meaningful
aoributes
rela3ve
to
product
profile,
customer
expecta3ons,
and
compe33ve
profiles
–
it
is
that
easy!
• Percep3ons
are
80%
reality
(Peter
Drucker
-‐
modified
Pareto’s
Principle)
• Remember
the
marke3ng
adage
form
product
launches
“You
are
not
actually
launched
unless
your
customers
can
recognize
and
tell
you
that
you
are”
• Never
issues-‐based!
An
issues-‐based
plan
is
never
op3mized.
In
an
op3mized
plan,
issues
are
nothing
more
than
a
bump
in
the
road.
Planning
for
issues
that
may
or
may
never
occur
waste
planning
3me
and
resources.
If
an
issue
is
large-‐enough
to
be
included
in
the
plan,
then
it
is
not
an
issue,
rather
a
cri3cal
success
factor
to
overcome
• Simple
to
understand
and
communicate
49
Confiden'al
50. Sample
PercepCon
Analysis…
Example:
Along
2
Aoributes:
Sa3sfac3on
and
Loyalty
Example:
Along
5
Geographic
Aoributes
50
Confiden'al
51. Mapping
Stakeholders
Interests
vs.
REMOXY
Pain
PosiCon
REMOXY
Has
Each
Stakeholder
Covered
Stakeholders
• Pa3ents
– BID
Pain
Coverage
with
no
breakthrough
pain
– Less
side-‐effects
(no
dose
dumping)
• Physicians
– Safety
(no
dose
dumping)
– Avoid
diversion
• FDA
– Promotes
general
safety
to
the
popula3on
• Payers
– Stops
PT
doc-‐seeking
cycle
thus
reducing
total
medical
costs
– Avoid
fraud
and
diversion
51
Confiden'al
52. P.E.S.T.
(PoliCcal,
Economic,
Social,
and
Technological
Analysis)
• Should
be
Included
as
part
of
planning
• Helps
define
cri3cal
success
pathways
The
PEST
factors
can
be
classified
as
opportuni3es
and
threats
in
the
S.W.O.T.
52
Confiden'al
53. S.W.O.T.
-‐
IniCal
Look
Internal
Factors
• Controlled
release
mechanism
intact
ater
40%
Ethanol
Weaknesses
Strengths
• Tmax
Significantly
greater
and
2X
• Slight
rate
of
absorp3on
increase
as
long
as
OxyCon3n
• Small
increase
in
Cmax
ater
co-‐
• Rate
of
absorp3on
with
40%
inges3on
with
ethanol
ethanol
id
similar
to
that
of
water
• High
bioavailability
External
Factors
Opportuni3es
• First
true
XRT
oxycodone
to
market
• FDA
–
stability
issues
Threats
• Physicians
will
feel
more
• Unmo3vated
or
uninterested
comfortable
prescribing
sales
force
• Managed
Markets
should
provide
coverage
immediately
53
Confiden'al
54. One
Last
Word
On
Strategy
Development
Most
organiza3ons,
independent
of
industry,
spend
very
liole
resources
on
strategy
development
• Brand
Engineers
es3mates
that
less
than
1%
of
budget
dollars
go
toward
strategy
and
posi3oning.
“ The
irony
in
this
is
that
these
are
the
marke3ng
aspects
that
ul3mately
drive
the
vast
majority
of
your
spend.
Even
if
you
allocated
2%
or
3%
to
ensuring
appropriate
strategic
and
posi3oning
insight,
would
that
s3ll
be
enough?”
Ill-‐Strategic
planning
leads
to
poorly
op3mized
tac3cal
plans
and
can
actually
do
more
harm
over
the
log-‐term
• Example:
Quiznos
Creatures
Campaign
Bad
Tac3cal
Ideas*:
The
Quiznos
creatures
Superimposed
over
a
Quiznos
sub
shop
were
two
disturbing,
singing
rat-‐like
creatures.
No
one
wanted
to
eat
in
a
place
associated
with
disease-‐ridden
rats.
Fortunately,
the
shop
got
wise
and
ditched
them
ater
public
outcry.
But
it’s
an
image
that
stays
with
you.
Quiznos
is
s3ll
recovering.
Go
ahead,
look
them
up
on
YouTube–but
don’t
say
you
weren’t
warned.
They
are
all
too
reminiscent
of
the
sort
of
guys
who
hang
outside
a
Quiznos
and
ask
for
your
change!
*Entrepreneur
Magazine,
Ten
Best
and
Worst
Campaigns
Ever,
January
29,
2009
54
Confiden'al
55. “TACDEVEX”
• TAC3cal
DEVelopmental
EXercises
are
not
new
concepts
• There
are
countless
exercises
to
prepare
a
team
for
posi3ve,
crea3ve
and
enjoyable
tac3cal
planning.
55
Confiden'al
56. TacCcal
Curve-‐Fikng
• Will
fast,
inexpensive
“buses”,
or
large,
preoy-‐
to-‐look-‐at,
slow-‐moving
“yachts”
to
take
you
where
you
need
to
go
on
3me?
• Not
all
tac3cal
ideas
are
appropriate
just
because
• everyone
is
doing
it
• it
has
been
done
this
way
for
years
• it
is
easy
• it
is
proven
to
work
• This
is
where
team
crea3vity
comes
in...
56
Confiden'al
57. Aktude
of
Team
Before
Exercises
• Kioen
vs.
Baby
Monkey
A}tude*
• Kioen
in
Danger
or
Confused
-‐
meows
and
waits
for
mother
• Baby
Monkey
-‐
runs
to
mother,
jumps
on
her
back
and
hangs
on
for
itself.
• These
exercises
are
for
monkeys!
• Control
Your
“FUDs”
• Nothing
is
more
harmful
to
posi3ve
crea3ve
a}tude
than
fears,
uncertain3es
and
doubt
(FUDs).
When
you
are
depressed,
your
thoughts
are
quite
different
from
when
you
are
happy.
When
you
feel
rich
and
successful,
your
thoughts
are
different
from
when
you
feel
poor
and
inhibited.*
*
Michael
Michalko,
Thinkertoys,
10-‐Speed
Press,
1991
57
Confiden'al
58. Human
Need
for
Consistency
• If
thoughts
are
inconsistent
with
other,
stronger
ideas,
then
the
mind
will
reject
them.
• Example:
Most
people
immediately
see
only
one
way
to
cut
“13”
in
half.
*
Michael
Michalko,
Cracking
Crea3vity,p2,
10-‐Speed
Press,
1991
58
Confiden'al
59. Need
a
Partner
in
Sales!!
Find
a
way
to
mo3vate
the
troops
while
op3mizing
the
por‚olio.
It
may
translate
into
changes
for
the
beoer.
Do
we
have
enough
SOV?
59
Confiden'al
60. Timothy R. Roe!
82 Sherry Lane
Kensington, CT 06037
(860) 829-6688 Home
(860) 518-5571 Cell
t.roe@m2details.com Email
www.m2details.com Web
Together,
we
can
make
the
“World
a
Beoer
Place”
THANK
YOU!
60
Confiden'al
62. SEVERE
PAIN
HAS
A
MAJOR
NEGATIVE
IMPACT
ON
EMOTIONAL
WELL-‐BEING
WHETHER
OR
NOT
PAIN
IS
UNDER
CONTROL
Husband
describes
wife’s
pain
as
“almost
being
a
third
person
in
our
marriage”.
Source:
American
Society
Web
Site
May
7,
2010
62
Confiden'al
63. SEVERE
PAIN
HAS
A
MAJOR
NEGATIVE
IMPACT
ON
QUALITY
OF
LIFE
WHETHER
OR
NOT
PAIN
IS
UNDER
CONTROL
Source:
American
Society
Web
Site
May
7,
2010
63
Confiden'al
64. Quality
of
Life
Improvement
on
NarcoCc
Pain
Reliever
THE
QUALITY
OF
LIFE
HAS
IMPROVED
SIGNIFICANTLY
AMONG
THOSE
WHO
HAVE
THEIR
PAIN
UNDER
CONTROL.
Source:
American
Society
Web
Site
May
7,
2010
64
Confiden'al
65. EMPLOYERS
ARE
NOT
AS
SUPPORTIVE
AS
CLOSE
FAMILY
AND
FRIENDS
OR
DOCTORS
Source:
American
Society
Web
Site
May
7,
2010
65
Confiden'al
66. PercepCon
of
Pain
Relief
by
Drug
Type
ALMOST
75%
OF
CHRONIC
PAIN
SUFFERERS
PERCEIVE
OTCs
AS
BEING
EFFECTIVE
IN
RELIEVING
MODERATE
TO
SEVERE
PAIN
A
MAJORITY
ALSO
BELIEVE
NARCOTIC
PAIN
RELIEVERS
AND
Rx
NSAIDS
WOULD
PROVIDE
EFFECTIVE
RELIEF
Source:
American
Society
Web
Site
May
7,
2010
66
Confiden'al
67. Current
Pain
Relief
MedicaCon
Usage
THOSE
WITH
VERY
SEVERE
PAIN
ARE
MORE
LIKELY
TO
USE
ANTI-‐DEPRESSANTS
AND
ANTI-‐SEIZURE
DRUGS
Source:
American
Society
Web
Site
May
7,
2010
67
Confiden'al
68. OPINION
IS
SPLIT
AMONG
CHRONIC
PAIN
SUFFERERS
BETWEEN
WANTING
TO
TAKE
PILLS
ONLY
WHEN
NEEDED
AND
BEING
ON
A
REGULAR
SCHEDULE
ALMOST
ALL
CHRONIC
PAIN
SUFFERERS
TAKE
THEIR
MEDICINE
IN
PILL
FORM;
IT
IS
ALSO
THE
PREFERRED
WAY.
A
SMALL,
BUT
SIGNIFICANT
NUMBER
OF
CHRONIC
PAIN
SUFFERERS
HAVE
AT
ONE
TIME
OR
ANOTHER
TURNED
TO
ALCOHOL
FOR
RELIEF
Source:
American
Society
Web
Site
May
7,
2010
68
Confiden'al
69. Severity
of
Pain
for
NarcoCc
Users
Source:
American
Society
Web
Site
May
7,
2010
69
Confiden'al
70. NarcoCc
User
-‐
SCgma
Measurement
AMONG
THOSE
WHO
HEAR
CONCERNS
FROM
OTHERS
IT
IS
LIKELY
TO
BE
A
FAMILY
MEMBER
OR
THEIR
DOCTOR
Source:
American
Society
Web
Site
May
7,
2010
70
Confiden'al
71. Risk
EvaluaCon
and
MiCgaCon
Strategy
Risk
evalua3on
and
mi3ga3on
strategies
(REMS)
formerly
known
as
Risk
Minimiza3on
Ac3on
Plans
(RiskMAPs)
are
a
regulatory
technique
for
dealing
with
an3cipated
risks
of
medica3ons
and
are
especially
important
for
new
drugs
with
abuse
poten3al.
71
Confiden'al
