1. SCIENT’X SAS DECEMBER 31, 2013
Vice President
EMEA
Raoul Bernhardt
Supply Chain Director
Jean-Luc Ranson
Human Resources
Director
Béatrice Machu
Demand & Planning Mgr
Etienne Herbet
Supplier Relations Mgr
Blaindine Bouvet
Customer Service Mgr
Gwénaëlle Target
Quality & Regulatory
Affairs Director
Arnaud Destainville
Process Validation Mgr
Sebastien Guette
Quality Systems Mgr
Cathy Bocahut
Vice President Finance
EMEA
Jean Yves Henry
Group Account Director
Anouk Pointier
Cost Control Manager
Stephanie Petit
Legal Manager
Franck Fasquel
Business Support Sr Mgr
Patricia Taillefer
Custumer Service
Coordinator
Annick Maldat
IT Manager
Yannick Philippe
COO and President
International,
Alphatec Holdings
W. Patrick Ryan
Market Mgr France & UK
Julie Plano
Coordinator,
Clinical Studies
Sabina Champain
Specialist, International
Products
Loic Leleu
Area Sales Manager
North of France
Christophe Besnard
Manager,
Marketing Support
Marie-Laure Deleplanque
Vice President Sales and
Marketing France & UK
Edouard Goetgheluck
Manager,
Group Products
Sophie Molinier
2. SUPPLY CHAIN
Vice President
EMEA
Raoul Bernhardt
Supply Chain Director
Jean-Luc Ranson
Executive Assistant GM
Sandrine
Boussemart
Demand & Planning Mgr
Etienne Herbet
Continuous Improvement
Coord.
Dorine Kochalski
Procurement Agent
Elisabeth Wintrebert
Finisher
Dominique Courtin
Finishing Operator
Clément Delboe
CNC Screw Machinist
Bruno Plouviez
CNC screw machinist
Rémy Vincent
CNC Screw Machinist
Olivier Orru
CNC screw machinist
Clément Thon
Distribution & Set
Admin Supervisor
Ludovic Payen
Maintenance technician
Raynold Cliquet
Team Leader
Rémy Nicoulaud
Procurement Agent
Pauline Bouhourdin
Procurement Agent
Stéphanie Pascual
Picking Agent
Cyril Desavis
Set Admin Supervisor
Stéphanie Nicoulaud
Picking Agent
Anthony Lebas
Receptionist Logistic
Agent
Cédric Cornee
Expedition Logistic
Assistant
Fabien Lefebvre
Set Processor
William Demoulin
Set administrator
Jérôme Sudol
Set Processor
Isabelle Boulet
5. Lotronex’s Market Share
5
All patients with
severe IBS
Patients taking
Lotronex
Most of the
prescriptions for
Lotronex come
from a small
number of
physicians
Option 1
6. Lotronex Has Failed to Meet Sales Expectation
6 Source: Boghigian Rep. ¶ 57-¶ 59
$0
$50
$100
$150
$200
$250
$300
$350
2007 2008 2009 2010 2011 2012 2013 2014
Actual Sales Expected Sales Downside Management Upside
Dollars in Millions
7. What Is a Royalty?
House Landlord Rent
Patent Licensor License Royalty
Renter
Licensee
Intellectual Property
Lease
Agreement
Agreement
Real Property
7
11. $0.00
$0.50
$1.00
$1.50
$2.00
How To Bridge the Gap Between the Parties
11
Royalties
Without any overlap
in the parties’
bargaining positions,
no deal can be reached
THE
GAP
Plaintiffs can
accept no less than
$1.80 in royalties
Defendants can pay
no more than
$1.27 in royalties
13. Updating Plaintiff’s Sales Forecasts
13
500
550
600
650
700
750
800
850
2008 2008 2009 2009 2010 2010
Plaintiff’s Expert’s Projection:
2.1654 Billion
500
550
600
650
700
750
800
850
2008 2009 2010
Difference:
132.5 Million
Keep this general
layout but change the
scale and the data
while keeping similar
lines. Change years.
14. What Problems Does the ’598 Patent Address?
14
• Not all POIs are equally important:
• For example, the Grand Opera House might be of interest to a regional
audience.
• But local businesses like “Quiznos Sandwich” and “Brew Haha!”
might be of interest to a more local audience.
15. ’598 Patent
Distributed Network of Data
Storage Devices
How Does The ’598 Patent Address
These Problems?
15
Centralized Data Storage
?
?
??
? ? ? ? ? ?i
i
ii
i i i i i i ?
?
??
? ? ? ? ? ?i
i
ii
i i i i i i
16. Distributed Network of Data Storage Devices
16Source: ’598 Patent
Distributed Network
• The ’598 Patent is directed at the storage and retrieval of location-based
information in a distributed network of data storage devices
Data Storage Devices
17. Claim 1 – Accessible Simultaneously
17
…accessible simultaneously from a plurality of remote user terminals…
Distributed Network of Data Storage Devices
i
i
ii i i i i i i?
?
?? ? ? ? ? ? ?
18. Google Maps Divides the World into
Map Tiles at Various Zoom Levels
18
…data defining a plurality of first localities in relation to which information
storage is accessible;
• Each map tile at every zoom level corresponds to a first locality.
• Google Maps defines map tiles at each zoom level with Cartesian
coordinates.
Tiles in Google Maps are numbered from the same
origin as that for pixels, so that the origin tile is
always at the northwest corner of the map. Tiles are
indexed using x,y coordinates from that origin. For
example, at zoom level 2, when the earth is divided
up into 16 tiles, each tile can be referenced by a
unique x,y pair:
19. 19
…data defining a plurality of first localities in relation to which information
storage is accessible;
Google Maps Divides the World into
Map Tiles at Various Zoom Levels
Zoom Level
3
Zoom
Level
1
Zoom
Level
0
• Each zoom level contains tiles representing the entire World.
Zoom
Level
2
1 Tile
4 Tiles
16 Tiles
64 Tiles
0,0
0,0 1,0
1,10,1
0,0 1,0
1,10,1
2,0 3,0
3,12,1
0,2 1,2
1,30,3
2,2 3,2
3,32,3
0,0 1,0
1,10,1
2,0 3,0
3,12,1
0,2 1,2
1,30,3
2,2 3,2
3,32,3
0,4 1,4
1,50,5
2,4 3,4
3,52,5
0,6 1,6
1,70,7
2,6 3,6
3,72,7
4,0 5,0
5,14,1
6,0 7,0
7,16,1
4,2 5,2
5,34,3
6,2 7,2
7,36,3
4,4 5,4
5,54,5
6,4 7,4
7,56,5
4,6 5,6
5,74,7
6,6 7,6
7,76,7
24. Approved Treatments for PAH
24
BID, twice daily; ERA, endothelin receptor antagonist; ET, endothelin; IV, intravenous; LFT, liver function test; PAH, pulmonary artery hypertension; PDE-5i, phosphodiesterase-5
inhibitor; QD, once daily; SC, subcutaneous; TID, three times daily. Hoeper MM et al. J Am Coll Cardiol. 2009;54:S85-S96; Simonneau G et al. J Am Coll Cardiol. 2009;54:S43-S54.
Drug Dosing Launch yr NotesProstacyclinanalogs
Flolan (epoprostenol) IV: 2ng/kg/mL, titrated to max 1995 “Gold standard”; Ice packs; headache
Remodulin (treprostinil) SC/IV 2002/04 Site pain, diarrhea, headache
Ventavis (iloprost) Inhaled: 6-9×/day 2005
Bayer/Actelion; chest pain, nausea
Time/inhalation
Tyvaso (treprostinil) Inhaled: 4×/day 2009 + delivery syst; headache
Veletri (epoprostenol) IV: 2ng/kg/mL, titrated to max 2010 Room temperature stable
ERA
Tracleer (bosentan) Oral BID: 62.5, 125mg 2001
Diarrhea, liver tox,
monthly LFT
Letairis (ambrisentan) Oral QD: 5, 10mg 2007 Selective ETA ; liver tox
PDE-5i
Revatio (sildenafil) Oral TID: 20mg (also IV) 2005/09 3 doses/day; headaches
Adcirca (tadalafil) Oral QD: 40mg 2009 1 dose/day; headaches, myalgia
For internal use only. Not to be copy or distributed.
4.1
25. Distribution of PAH Therapy Utilization
25
0
20
40
60
80
100
Initial Therapy Therapy Adjustment at 1st Follow-up*
ERA PDE-5i ERA PA PDE-5i CCB
PatientsonPAHOralTherapies(%)
* Total is greater than
100% since some
patients are on
multiple agents.
n=251
n=455
n=306
n=56
n=533
n=147
CCB, calcium channel blocker; ERA, endothelin receptor antagonist; PA, prostacyclin analog; PAH, pulmonary arterial hypertension; PDE-5i, phosphodiesterase-5 inhibitor.
Angalakuditi M et al. J Med Econ. 2010;13:393-402.
Patients(%)
Retrospective claims database analysis of 706 patients with PAH enrolled in a large,
geographically diverse US managed-care organization
For internal use only. Not to be copy or distributed.
0
20
40
60
80
100
4.1
26. Substantial Gains With Treatment:
Median Survival Times Have Lengthened
0%
20%
40%
60%
80%
100%
0 1 2 3 4 5 6 7
Survival
Years of follow-up
NIH registry (1981-1985)
REVEAL registry (2001-2009)
26
Median survival
2.8 years
Median survival
expected to be
>7 years
NIH, US National Institutes of Health; REVEAL, Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management. D’Alonzo GE et
al. Ann Intern Med. 1991;115:343-349. Benza RL et al. CHEST. 2012;142:448-456.
For internal use only. Not to be copy or distributed.
4.1
27. ESC/ERS Guidelines: Assessment
and Monitoring Recommendations
• Suggested assessments and timing for follow-up of PAH patients,
ESC/ERS guidelines
For internal use only. Not to be copy or distributed.27
At baseline
(prior to
therapy)
Every 3-6
months*
3-6 months after
initiation or changes
in therapy
In case of clinical
worsening
Clinical assessment WHO-
FC ECG
6MWD†
Cardiopulmonary
exercise testing†
BNP/NT-proBNP
Echocardiography
Right heart catheterization ‡ § §
6MWD, 6-minute walk distance; BNP/NT-proBNP, brain natriuretic peptide/N-terminal prohormone of BNP; ECG, electrocardiograph; ERS, European Respiratory Society;
ESC, European Society of Cardiology; FC, functional class; PAH, pulmonary arterial hypertension; WHO, World Health Organization. Eur Resp J. 2009;34:1219-63.
4.1
Include footnote to
explain superscripts
28. Diuretics
• Diuretics are used to treat fluid retention
(edema) due to PH because duiresis will
diminsh hepatic congestion and
peripheral edema
• Should be used with caution to avoid
decreased cardiac output (due to
decreased right and/or left ventricular
preload), arrythmias produced by
hypokalemia, and metabolic alkalosis
Galie. Eur Heart J. 2009;30:2493-537.
4.2
29. Anti-coagulation
• Patients with PH are at increased risk
for intrapulmonary thrombosis and
thromboembolism due to
• Sluggish pulmonary blood flow
• Dilated right heart chambers
• Venous stasis
• Sedentary lifestyle
• Even a small thrombus can produce
hemodynamic deterioration in a
patient with a compromised vascular
bed that is ubable to dilate or recruit
unused vasculature
Barst. JACC. 2009;54:S78-84. Galie. EHJ. 2009;20:2493.
4.2
30. Inhalation with Iloprost: Case Report
CO
SaO2
PAP
CO(l/min)
SaO2(%)
PAP(mmHg)
5
100
90
9060300
40
75
3
Iloprost Inhalation
Minutes
Olschewski. Ann Int Med. 1996;124:820-4.
4.3
31. Bosentan 125 mg (n = 74)
-40
-20
0
20
40
60
80
Bosentan 250 mg (n = 70)
Placebo (n = 69)
Baseline Week 4 Week 8 Week 16
62.5 mg/bid 125 or 250 mg/bid
6-MWT(m)
Mean ± SEM
BREATHE-1
Results: Change in 6MWD
Rubin. NEJM. 2002;346:896-203.
54 meters
35 meters
No Dose
Response at
250mg
despite these
6MWD
4.4
33. PDE-5 Inhibition
For internal use only. Not to be copy or distributed.33
GMP
cGMP
Vasorelaxation and antiremodeling
NO
GTP PKG
↑cGMP
PDE-1, 2
PDE-6, 9, 10,
11
PDE-5
sGC
eNOS
4.5
PDE-5
inhibitors
34. STEP-1: Bosentan + Iloprost or Placebo
Change in 6 MWD and Time to Clinical Worsening
-75
-50
-25
0
25
50
75
Baseline Week 4 Week 8 Week 12
Changefrombaselinein6MWD
0
0.2
0.4
0.6
0.8
1
0 14 28 42 56 70 84
Time in days
Proportionfreeofclinicalworsening
McLaughlin V, et al. Am J Respir Crit Care Med 2006;174:1257-1263.
Iloprost
Placebo
6 MWD Clinical worsening
Placebo adjusted difference: + 26 m
(P=0.051)
(P=0.022)
32
32
31
31
31
28
31
27
31
27
21
18
Iloprost, N=
Placebo, N=
35. 35
ABOUT 80% OF THE SPINAL IMPLANT MARKET
IS IN THE UNITED STATES
36. 36
France
D E F E N D A N T
Surgiview
OrthoTec
P L A I N T I F F
39. 39
EUROSURGICAL IS NEAR THE COURT OF ARRAS
PARIS:
Surgiview
BEAURAINS:
Eurosurgical
ARRAS:
Court
F R A N C E
40. 40
July 22, 2004
French Court
appoints Meynet
as Administrator
Aug 6, 2004
Meynet meets
with Bertranou
Sep 16, 2004
Meynet recommends
two-year lease
Sep 29, 2004
French Court
approves two-year
lease to Surgiview
Oct 11, 2004
Surgiview signs
distribution agreement
with Scient’x
July 1, 2005
Scient’x buys 74%
of Surgiview
May 3, 2006
French Court appoints
Meynet as conciliator
Oct 20, 2006
French Court
approves
Surgiview’s
purchase of
Eurosurgical
assets not owned
by OrthoTec
2004 2005 2006
42. 42
ACTH-independent Cushing’s Syndrome
(20% of cases)
ACTH-independent Cushing’s
syndrome (20% of cases)
• Cortisol is overproduced because of
an abnormality on the adrenal
glands
ACTH-dependent Cushing’s
syndrome (80% of cases)
• Ectopic: Extra-pituitary ACTH-
secreting tumor
• Cushing’s disease: ACTH-
secreting pituitary tumor
- High ACTH in turn produces
increased cortisol
- Deregulation of the HPA feedback
loop
Arnaldi G et al. J Clin Endocrinol Metab. 2003 Dec;88(12):5593–602. Review
43. 43
Cushing’s Syndrome
Diagnostic Algorithm
Nieman LK et al. J Clin Endocrinol Metab. 2008 May;93(5):1526–40.
Perform 1 of the following tests
24 hour UFC (≥2 tests)
Overnight 1 mg DST
Late night salivary cortisol (≥2 tests)
48 hour 2 mg DST in certain cases
Patients with suspected Cushing’s syndrome
without exposure to exogenous glucocorticoids
NormalDiscrepant Abnormal
Cushing’s syndromeAdditional evaluation CS unlikely
CS
unlikely
Normal
Abnormal
Exclude physiologic causes of hypercortisolism
Consult endocrinologist
Perfrom 1 or 2 of the studies above (or repeat studies)
Perform Dex-CHR or midnight serum cortisol in certain cases
44. 44
Differential Diagnosis of Cushing’s Disease
Nieman LK et al. J Clin Endocrinol Metab. 2008 May;93(5):1526–40 .
Cushing’s syndrome
Perform CRH
stimulation test
Measure plasma ACTH
ACTH independent
Cushing‘s syndrome
Perform pituitary
MRI Perform adrenal CT
or MRI
Perform bilateral inferior
petrosal sinus sampling
Cushing’s disease
Search for ectopic
ACTH source
Search for ectopic
ACTH source
Abnormal
Normal/
equivocal
Normal/
equivocal
High
Low
Positive
Negative
Normal/
equivocal
Positive
45. 45
Treatment of Cushing’s Disease
The treatment goals in Cushing’s disease are
Reversal of clinical features
Normalization of biochemical changes with minimal
morbidity
Long-term control without recurrence
Biller BMK et al. J Clin Endocrinol Metab. 2008;93:2454-2462.
46. 46
Symptoms noticed
• Weight gain
• Don’t feel well
• Easily fatigued
• Mood changes
Patient’s Journey: An Overview
Seek medical advice, treated for
HTN, diabetes, osteoporosis,
depression, ADHD, and other
symptoms
PCP
Endo
Other
specialist
Patient most likely
to get to Endo if:
• Has diabetes, especially if hard
to control
• Weight gain questions
• Patient self-refers
Endo conducts tests
• Other testing done
(eg, thyroid) before get
to CD detection
If early testing equivocal:
• May be repeated
• Other tests (eg, salivary cortisol)
may be conducted
• MD may rule out CD
• Patient may seek other MD
ACTH serum
testing
Imaging of
pituitary
TSS 1st choice—potentially “cure”
• If tumor confirmed surgery
within 3-6 months
Normalized
cortisol levels:
• “Cure”
• Monitor over
time
Cortisol levels remain
above normal; patient
continues to have symptoms;
recurrence:
No good options at present
• Meds (toxicity, lack efficacy)
• 2nd pituitary surgery
• Radiotherapy
• BLA
May take 5+ yrs to get to Endo Diagnosis process can take 1+ yrs Treatment
24 hr UFC
Dex
suppression
47. 47
Patient’s Frustrations and Societal Withdrawal Were Poignantly
Illustrated Within Their Journals
HighpointsPainpoints
Pre-diagnosis Diagnosis process Initial treatment Later treatment
Surgery was to = Cure,
feeling as bad or worse
than before surgery
– Fatigue
– Weight gain
– Muscle weakness
– Pain
Fatigue, other pre-
surgery symptoms
may take time to
dissipate
Diagnostics a hassle,
intrusive, must live
with fatigue, other
physical symptoms
It could be
Cushing’s—at
last, possible
answer
Surgery
could be
“Cure”
Gaining weight, fatigued,
pain, restless, but not
sure what is wrong
Bonding with Endo
important during
this time
Potentially return to
more normal social
interactions
“I don’t want to live like
this the rest of my life” –
From patient interview, US
48. 48
Treatment Options Are Limited - No “ideal”
Option, No Clear Protocol After the First TSS
TSS 1st Line Tx Cortisol levels remain
above normal
• Patient continues to have
symptoms
Monitor
over time
Medical Therapy
-Not that effective
- Serious SEs
Bilateral
adrenalectomy
- Drastic
- Patient on meds for life
- Can create other problems
(eg, Nelson’s syndrome)
Radiotherapy
- Takes time to determine effect
- Can cause broader damage
2nd pituitary surgery
-Less effective
- Creates other
hormonal problems
If chemical remission,
lingering patient symptoms
essentially ignored—should
“go away” eventually
Biochemical
remission:
• “Cure”
Tumor recurs
49. 49
At Month 6, the Majority of Patients Had a Reduction From Baseline in
UFC
Patient
mUFC(nmol/24h)
0
500
1000
1500
2000
4000
7000
Pasireotide 600 µg bid Pasireotide 900 µg bid
Baseline mean UFC Month 6 mean UFC Month 6 responder*
Change in UFC at month 6 in the 103 patients with baseline and month 6 UFC measurements
Sorting is by baseline mean UFC value
The reference line is the upper limit of normal, UFC, which is 145 nmol/24 h
52. 52
Signifor Vision
To be the backbone of therapy for the treatment of pituitary and gastroenteropancreatic
neuroendocrine tumors, the definitive agent to show total disease control of tumor AND
symptoms
Signifor Positioned for Superior Disease Control
Signifor Positioning*
Clearly Define the
“Signifor”
Patient
• Surg/Rx failure
• When tumor is not
localized
• While waiting for
surgery
SI1
Clearly Articulate
the Benefits of
Signifor Tx
• Biochemical control
• Tumor control
• “Pituitary-directed”
• “Pituitary-sparing”
SI2
Differentiate From
Somatostatin
Analogs & Other Tx
• MOA, rational design
• Clinical efficacy
• Value proposition
• Broad range of
pituitary tumors
SI3
Increase Clinical
Experience
• Expanded GMA
program
• Expanded
development
program
• Rapid completion of
all registration
studies
Implement Life
Cycle
Management to
Maximize Brand
Value
• LAR studies
• New indications
• Explore other
formulations
SI5
For pituitary-treating endocrinologists, Signifor is the
first multi receptor targeted somatostatin analogue
that offers superior disease control in multiple
pituitary tumors
SI14
Vision and Positioning statements are aspirational and are not necessarily reflective of current labels – often will include developing clinical data
* Placeholder, MR on final positioning ongoing
53. 53
Cushing’s Disease: Market Overview and Trends
Positive growth drivers
• High unmet medical need
• % of patients without
localized tumors
Key negative growth factors
• Ketoconazole:
low price, oral
• Dopamine agonists:
low price, oral
Treatment of Cushing’s Disease–2009
Shares are approximate based on estimates from market research regarding 1st line treatments
Adrenalectomy 1%
Radiation
4%
Medical Therapy
25%
Successful Surgery
70%
Mitotane/
Metyrapone 7%
Ketoconazole
18%
54. 54 54
2010 2011
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
RegistrationMarketReadiness
BrandStrategyand
CPOReadiness
Countdown to Cushing’s Disease Launch
Global Activities At-a-Glance
CPO Education Kits
Cushing’s disease slide
kits
Strategic planning
SDP Sep
FIR 12m: May
CDBL May
LPLV
Mar
Cushing’s Disease Ph III
Oct EU
Submission
May US
Submission
Early Access Pgm
Promotional Support (Unbranded, Web, Convention, PASPORT) Launch Materials (Vis Aid, Branding Guidelines, Convention)
CPO Planning Kits
Launch planning
Forecast model
and training
Cushing’s Disease Ph III – LAR
PR Materials
Packaging
Value
Dossier Approved
Price CD
Launch
Scientific Communications – Clinical, Economic, MA – Pubs, Abstr, Symposia
Health Economics
Burden of illness
Cost of sub-optimal therapy
Cushing’s QoL validation
Investigator Mtgs,
Ad Bd
Patient
Roundtable
CPO Launch Readiness
Market Research
Rx drivers
Forecast model
KOL mapping
Positioning & messaging
Branding
Global brand strategy
Global launch plan
Trade name
Branding elements
EU Go-To-
Launch
Mtg
PRE Go-
To-Launch
Mtg (1)
PRE Go-
To-Launch
Mtg (2)
55. 55
Cushing’s Regulatory Strategy Is Moving Forward
Global Submission Strategy Based on 12 Months Data From B2305
EU
•Submission: Oct 2010 / submit results from 2nd TQT study with day 120 LoQ
•Approval: Dec 2011
US
•Submission: May 2011 (FDA unlikely to consider 2nd TQT study during review)
•Approval: Nov 2011 (assuming Priority Review)
Switzerland
• Submission: Dec 2010 / Submission of 2nd TQT during review accepted by HA
• Approval: Jun 2011 (assuming Fast Track)
ROW
• Submissions planned with exception of Japan (Japan participates in Cushing’s
LAR program)
• Prioritization and roll out in discussion with CPOs
56. 56
Market Research Timelines: Positioning Research Has Begun
2010 2011
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Positioning Development
and Testing
Core Message &
Prelaunch Concept
Development and
Testing
Launch Concept
Development and Testing
Sales Aid Development and Testing
Pre Go-
To-
Launch
Meeting
EU &
CH
Subm
US
Subm
Global
materials
Ready
Go-to-
Launch
Meeting
US
App
EU
App
Cushing’s Disease
57. 57
Announce Cushing’s Data and Regulatory Milestones
PR to Educate Media and Prepare for Successful Launch in 2010
Prepare internal and external spokespeople
Develop launch PR toolkit
JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
European Congress of
Endocrinology (ECE)
Prague, Czech
Republic
24-28 April
The Endocrine
Society (ENDO)
San Diego, CA
19-22 June
FDA File
Acceptance
Swiss Approval
(Up-side scenario)
ECE data press release
Science writer’s workshop
onsite
Leverage first approval
as global milestone
Press release and top tier
media outreach
ENDO press release
One-on-one media
interviews with medical
experts
Leverage US and EU
positive milestones
Press release and top-
tier media outreach
EMEA Positive
Opinion
Prepare press releases, Q&As, support materials across milestones; consider social media opportunities to
expand reach
Coordinate with country communicators to engage and maximize opportunities
FIR
Dec EMEA Submission
FDA Submission
Waiting for Updated Data 2010-2011 Timeline
58. 58
Signifor Launch Training Plan
Endocrine A&P
AugQ1 Sept Oct Nov DecJulyQ2Q4
SOM230 Objection
Handler
SOM230
Go-To-Launch
Meeting
Understanding Cushing's
Disease
Management of Cushing's
Disease
Pasireotide
SOM230 Go-To-
Launch Prework
Live Preceptorship
Kit
Patient Case
Series Flashcard
2010KickOff
Disease Awareness Objection
Handler
Cx Assessments
Patient Case Series Flashcards
Disease State, Diagnosis
Representative
Launch Training
ASM Coaching
Guide
Annotated
Clinical Reprint
Print-based
Competitive Flashcards
59. 59
B2305 2010 Publication Timelines
Somatostatin
Receptor
complexity
ACTIVITY MAR 10 APR 10 MAY 10 JUN 10 JUL 10 AUG 10 SEPT 10 OCT 10 NOV 10 DEC 10
ABSTRACTS
MANUSCRIPTS
ICE B2305
study design
poster
ENDO B2305
UFC variability
poster
ENEA B2305
oral presentation
Sept 23
B2305 ENEA
abstract submission
(post deadline)
ECE, ENDO, &
IPS 2011
abstract initiation
12-month data
manuscript
UFC variability
manuscript
Submission
(JCEM)
Submission
(NEJM)
60. 60
B2305 2010 Key Activities
Somatostatin
Receptor
complexity
ACTIVITY MAR 10 APR 10 MAY 10 JUN 10 JUL 10 AUG 10 SEPT 10 OCT 10 NOV 10 DEC 10
DATA
MILESTONES
CONGRESSES
INVESTIGATOR
ACTIVITY
SATELLITE
SYMPOSIA
& CONGRESS
EVENTS
INTERNAL
MEETINGS
Draft
CSR available
DB
lock
12-month
data available
FIR
Region
Europe/Italy
Round Table
ENDO
19-22 Jun
San Diego, CA
ENEA
22-25 Sept
Liege, Belgium
ICE
satellite
symposium
ECE
satellite
symposium
Novartis
evening
event
(ENDO)
ENEA
B2305 internal
newsflash
ENEA
satellite symposium
Sept 23
ENDO
poster
author
discussion
Apr 24
Steering
committee &
investigator
meeting
Jun 17
ENDO
poster
author
discussion
May 27
Global marketing
strategy meeting
Communication taskforce
(PR, marketing, Sci Com)
Face-to-face
publication
planning meeting
61. Conspiracy period
Plea period
61
0
20
40
60
80
100
120
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Priceindex(Jan1996=100)
Large TFT panel actual price index
But-for price index (conspiracy period)
But-for price index (plea period)
But-for price index for the dynamic prediction model – large panels
What Happened Here?
62. What Happened Here?
62
Conspiracy period
Plea period
0
20
40
60
80
100
120
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Priceindex(Jan1996=100)
Large TFT panel actual price index
But-for price index (conspiracy period)
But-for price index (plea period)
But-for price index for the dynamic prediction model – large panels
63. What Happened Here?
63
Conspiracy period
Plea period
0
20
40
60
80
100
120
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Priceindex(Jan1996=100)
Large TFT panel actual price index
But-for price index (conspiracy period)
But-for price index (plea period)
But-for price index for the dynamic prediction model – large panels
65. What’s the Product at Issue?
65
Top Front Cover With Glass
Speaker
LCD
Top Back Cover
Bottom Front Cover
With Key Pad
Key Pad Controller
Circuit Board
Microphone
Bottom Back Cover
Microprocessor
66. What’s the Product at Issue?
66
Fluorescent Lights
Glass Plate
Electrodes
Liquid Crystal
Electrodes
Light Filter
Glass Plate
69. Conspiracy period
Plea period
69
But-for price index for the dynamic prediction model – small panels
0
20
40
60
80
100
120
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Priceindex(Jan1996=100)
Small TFT panel actual price index
But-for price index (conspiracy period)
But-for price index (plea period)
