Market research plan supporting the commercialization of Northera for NOH (neurogenic orthostatic hypotension).

1. By
Will
Roettger
Principal
Consultant
20/20
Market
Insights,
LLC
November
8,
2010

2. Will
Roettger
is
an
established
career
professional
in
the
pharmaceutical
and
biotech
industry.
Having
worked
for
Novartis,
AstraZeneca,
Merck,
Alexion,
and
Dendreon
he
has
developed
expertise
across
the
therapeutic
areas
of
oncology,
hematology,
and
immunology
for
pipeline
and
launch
products.
He
has
been
instrumental
in
establishing
marketing
intelligence
as
a
core
capability
in
support
of
clinical
and
commercial
new
product
development,
solving
the
many
commercial
challenges
that
high-­‐priced
specialty
products
face
from
a
patient,
provider,
and
investor
perspective.
Additionally
he
has
supported
two
specialty
product
launches,
providing
actionable
insights
and
recommendations
by
integrating
market
research
findings
with
competitive
intelligence.
As
a
principal
for
20/20
Market
Insights,
LLC,
he
is
dedicated
to
providing
clients
with
clear
vision
into
competitor
landscapes,
strategies,
and
product
assessments
that
drive
strategic
business
decisions
in
new
drug
development.
Contact
Information:
Will
Roettger
Principal
Consultant
20/20
Market
Insights,
LLC
908-­‐391-­‐4362
will.roettger@gmail.com
2

4. 4

5. 5

6. 6

7. 1. Chelsea
Therapeutics.com
7

8. 8

9. 9

10. 1. FDA.gov.
10

11. 1. FDA.gov.
11

12. 1. FDA.gov.
12

13. 1. FDA.gov.
2. Shire.com,
August
17,
2010
press
release
13

14. 1. Clinical
Trials.gov
14

15. 1. Clinical
Trials.gov
15

16. 16

17. 17

18. 18

19. Pre
Launch
19

20. Pre
Launch
20

21. Pre
Launch
21

22. Post
Launch
22

23. Post
Launch
23

24. 24

25. 1. CAR,
Update
on
NOH,
Kaufamm,
March
2008,
vol.18,
suppl.
125

26. 1. Merck
Manual
2009-­‐2010,
Ch
86,
Section
11.
2. Rutan,
GH,
Hermanson,
B,
Bild,
DE,
et
al.
Orthostatic
hypotension
in
older
adults:
The
Cardiovascular
Health
Study
CHS
Collaborative
Research
Group.
Hypertension
1992;
19:508.
3. J
Gerontol
A
Biol
Sci
Med
Sci
(2000)
55
(8):
M458-­‐M462.
Diagnostic
Yield
and
Development
of
a
Neurocardiovascular
Investigation
Unit
for
Older
Adults
in
Hospital.
Liesl
Allcock
4.
Allcock
LM,
Ullyart
K,
Kenny
RA,
Burn
DJ
(2004)
Frequency
of
orthostatic
hypotension
in
a
community
based
cohort
of
patients
with
26
Parkinson’s
disease.
J
Neurol
Neurosurg
Psychiatry
75:1470–1471

27. 27

28. 28

29. Secondary
Data
Market
Insight
Study
TPP
Testing
ATU
Tracker
Segmentation
Positioning
Messaging
29

30. Physician
Insights
Patient
Insights
Concept
Testing
Detail
Aid
Testing
Pricing
Research
30

31. Medical
Claims/
EMR
Data
Rx
Data
ATU
Tracking
Analytics
Message
Recall
Analytics
31

32. Northera™
NOH
Global
Market
Research
Plan
(2010-­‐2012)
2
0
1
0
G5
G5
June
May
Apr
Mar
US
Jan
US
2
0
1
1
2
0
1
2
Forecast
ATU
Market
Product
Form
Detail
Aid
Tracker
–
Model
I
Insight
&
&
Packaging
Development
pre
launch
Segmentatio
Research
(Qual)
TPP
Testing
n
Concept
Patient/
Positioning
(Quant)
Patient
Ed
Branding
Developmen
Support
Group
Ideation
Developmen
TPP
Testing
Detail
Aid
t
(Qual)
Insight
Study
(Qual)
t
(Qual)
Development
Positioning
Concept
(Qual)
(Quant)
Evaluation
Developmen
(Quant)
t
(Quant)
PEST
Evaluation
Strategy
Development
Launch
G5
Dec
Aug
US
Jul
Jun
May
Apr
US
Mar
Feb
Jan
US
Dec
Nov
Oct
US
G5
Nov
G5
Oct
G5
DDMAC
NDA
Feb
Phase
III
Trial
Data
(306)
Sep
Phase
III
Trial
Data
(301)
Forecast
Model
II
ATU
Tracker
(baseline
)
EU
Market
Insight
&
Segmentatio
n
Messag
e
Recall
ATU
Tracker
(Wave
1)
Product
Persistency
/
Complianc
e
Study
Ongoing
Performance
Analytics/SFE
Tactics
32
evelopment
D
Performance
Assessment

33. SCOPE
US
US
US
US
US
US
US
US
US
US
US
US
US
US
US
US
US
2011 - 2012
Positioning - Ideation (Qual)
Positioning - Evaluation (Quant)
Branding
TPP Testing (Qual)
TPP Testing (Quant)
Patient Support Group Insight Study (Qual)
ATU Tracker - Pre Launch
Concept Development (Qual)
Concept Test (Quant)
Detail Aid Development (Qual)
Detail Aid Test (Quant)
Product Packaging Research
Patient Ed Development
ATU Tracker - Baseline
ATU Tracker – Wave 1
Message Recall
Product Persistency/Compliance Study
COST
40,000
75,000
60,000
40,000
75,000
30,000
65,000
30,000
70,000
40,000
75,000
60,000
30,000
60,000
60,000
60,000
65,000
$ 935,000
Sub Total
1. Does
not
include
data
purchases
such
as
IMS,
SDI,
Datamonitor,
Decision
Resources,
etc.
33

34. %
Time
%
Time
35%
50%
30%
40%
25%
10%
8%
Primary
Secondary
CI
2%
SFE
Primary
34
Secondary
CI
SFE

35. 35

36. 1. Manhattan
Research’s
–
e-­‐Pharma
Physician
Report.
2. SK
&
A
Research
Survey
36

37. 1. Manhattan
Research’s
–
e-­‐Pharma
Physician
Report.
2. SK
&
A
Research
Survey
37

38. 1. Manhattan
Research’s
–
e-­‐Pharma
Physician
38

39. 39

40. 40

41. 41

42. 42

43. 43

44. 44

45. 1. JAMIA
2010;17:403-­‐410
doi:10.1136/jamia.2010.005660,
Cornelia
M
Ruland,
Effects
of
a
computer-­‐supported
interactive
tailored
patient
assessment
tool
on
patient
care,
symptom
distress,
and
patients'
need
for
symptom
management
support:
a
45
randomized
clinical
trial

46. 1. Online
Depression
Assessment
Tool
Validated,
Preferred
by
Patients
Friday,
July
30,
2010
-­‐
Elsevier
Global
Medical
News
By
Damian
McNamara.
http://www.medconnect.com.au//tabid/84/s25/Pain-­‐Anaesthesia/ct1/c337854/Online-­‐Depression-­‐
46
Assessment-­‐Tool-­‐Validated-­‐Preferred-­‐by-­‐Patients

47. 47

48. 48

49. Will
Roettger
Principal
Consultant
20/20
Market
Insights,
LLC
908-­‐391-­‐4362
will.roettger@gmail.com
49