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SCIENT’X SAS DECEMBER 31, 2013Vice President
EMEARaoul Bernhardt
Supply Chain DirectorJean-Luc Ranson
Human Resources Director
Béatrice Machu
Demand & Planning MgrEtienne Herbet
Supplier Relations MgrBlaindine Bouvet
Customer Service MgrGwénaëlle Target
Quality & Regulatory Affairs Director
Arnaud Destainville
Process Validation MgrSebastien Guette
Quality Systems Mgr Cathy Bocahut
Vice President Finance EMEA
Jean Yves Henry
Group Account DirectorAnouk Pointier
Cost Control Manager Stephanie Petit
Legal ManagerFranck Fasquel
Business Support Sr MgrPatricia Taillefer
Custumer Service Coordinator
Annick Maldat
IT ManagerYannick Philippe
COO and President International,
Alphatec HoldingsW. Patrick Ryan
Market Mgr France & UKJulie 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 & UKEdouard Goetgheluck
Manager,Group ProductsSophie Molinier
SUPPLY CHAINVice President
EMEARaoul Bernhardt
Supply Chain DirectorJean-Luc Ranson
Executive Assistant GMSandrine
Boussemart
Demand & Planning MgrEtienne Herbet
Continuous ImprovementCoord.
Dorine Kochalski
Procurement AgentElisabeth Wintrebert
FinisherDominique Courtin
Finishing OperatorClément Delboe
CNC Screw MachinistBruno Plouviez
CNC screw machinistRémy Vincent
CNC Screw MachinistOlivier Orru
CNC screw machinistClément Thon
Distribution & Set Admin Supervisor
Ludovic Payen
Maintenance technicianRaynold Cliquet
Team LeaderRémy Nicoulaud
Procurement AgentPauline Bouhourdin
Procurement AgentStéphanie Pascual
Picking AgentCyril Desavis
Set Admin SupervisorStéphanie Nicoulaud
Picking AgentAnthony Lebas
Receptionist Logistic Agent
Cédric Cornee
Expedition LogisticAssistant
Fabien Lefebvre
Set ProcessorWilliam Demoulin
Set administratorJérôme Sudol
Set ProcessorIsabelle Boulet
The ’309 Patent
3JTX 002, Fig. 1
The ’309 Patent
4JTX 002, Fig. 1
Lotronex’s Market Share
5
All patients with
severe IBS
Patients taking
LotronexMost of the
prescriptions for
Lotronex come
from a small
number of
physicians
Option 1
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
What Is a Royalty?
House Landlord Rent
Patent Licensor License Royalty
Renter
Licensee
Intellectual Property
Lease
Agreement
Agreement
Real Property
7
Investigation
Calculations
Testing3
2
1
Summary of Approach
8
Confirm Opinions
Check Conclusions for
Reasonableness
Consider Expert Opinions
Fact Finding
Key Issues
Reasonable Royalty on
Recent Sales
Reasonable Royalty on
All Sales
Lost Royalties
9
0
250
500
750
1,000
1,250
1,500
1,750
2,000
Product
Infringing Sales
Infringing Sales Caused Product Sales To Plummet
Product
drops 80%
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
$0.90
$1.10
$1.30
$1.50
$1.70
$1.90
$2.10
$2.30
Q42008
Q12009
Q22009
Q32009
Q42009
Q12010
Q22010
Q32010
Q42010
Q12011
Q22011
Q32011
Q42011
Plaintiffs Suffered Price Erosion
10
Product Price If No Copy
Product Actual Price
Price Erosion
$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
Updating the Market Share
12
14%
16%
18%
20%
Plaintiff
Forecasts
Defense
Expert’s Update
0%
18.7%
18.3%
17.2%
15.5%
14.7%
16.4%
17.4%
2008 2009 2010 2011
Market Share
Exaggeration
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.
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.
’598 PatentDistributed Network of Data
Storage Devices
How Does The ’598 Patent Address
These Problems?
15
Centralized Data Storage
??
??
? ?? ? ? ?
ii
ii
i ii i i i
??
??
? ?? ? ? ?
ii
ii
i ii i i i
Distributed Network of Data Storage Devices
16Source: ’598 PatentDistributed 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
Claim 1 – Accessible Simultaneously
17
…accessible simultaneously from a plurality of remote user terminals…
Distributed Network of Data Storage Devices
ii
iii i
i i i i?
???
? ?? ? ? ?
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
…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 Tile4 Tiles
16 Tiles
64 Tiles
0,00,0 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
© DecisionQuest 2014 Confidential & Privileged Attorney Work Product
2%
5%
2%
6%
16%
28%
42%
21%
38%
40%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
James White
Alexander Trevor
Extremely Quite Somewhat A little bit Not at all
Nervous
© DecisionQuest 2014 Confidential & Privileged Attorney Work Product
30%
9%
53%
53%
12%
14%
5%
12% 12%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
James White
Alexander Trevor
Extremely Quite Somewhat A little bit Not at all
Knowledgeable
© DecisionQuest 2014 Confidential & Privileged Attorney Work Product
26%
21%
32%
23%
30%
33%
12%
14% 9%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
James White
Alexander Trevor
Extremely Quite Somewhat A little bit Not at all
Easy to Understand
© DecisionQuest 2014 Confidential & Privileged Attorney Work Product
9%
7%
19%
21%
28%
72%
44%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
James White
Alexander Trevor
Extremely Quite Somewhat A little bit Not at all
Evasive
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 NotesP
rost
acyc
lin a
nal
og
s
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 2005Bayer/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
ER
A Tracleer (bosentan) Oral BID: 62.5, 125mg 2001Diarrhea, liver tox,
monthly LFT
Letairis (ambrisentan) Oral QD: 5, 10mg 2007 Selective ETA ; liver tox
PD
E-5
i 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
Distribution of PAH Therapy Utilization
25
0
20
40
60
80
100Initial Therapy Therapy Adjustment at 1st Follow-up*
ERA PDE-5i ERA PA PDE-5i CCB
Pat
ient
s on
PA
H O
ral T
hera
pies
(%
)
* 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.
Pat
ient
s (%
)
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
Substantial Gains With Treatment:
Median Survival Times Have Lengthened
0%
20%
40%
60%
80%
100%
0 1 2 3 4 5 6 7
Su
rviv
al
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
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
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
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
Inhalation with Iloprost: Case Report
CO
SaO2
PAP
CO
(l/m
in)
SaO
2(%
)
PA
P (
mm
Hg
)
5
100
90
9060300
40
75
3
Iloprost Inhalation
Minutes
Olschewski. Ann Int Med. 1996;124:820-4.
4.3
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-M
WT
(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
5 mg2.5 mg 5 mg 10 mg
* *
0
20
40
60
ARIES 1
(n=201)
ARIES 2
(n=192)
31m
51m
32m
59m
Combined 5mg group = 45m
ARIES-1 and 2 Results: 6MWD
Galie. Circulation. 2008;117:3010-9.
Letairis Prescribing Information. Gilead Sciences. 2011.
5mg and 10mg
approved
4.4
PDE-5 Inhibition
For internal use only. Not to be copy or distributed.33
GMP
cGMP
Vasorelaxation and antiremodeling
NO
GTPPKG
↑cGMP
PDE-1, 2
PDE-6, 9, 10,
11
PDE-5
sGC
eNOS
4.5
PDE-5
inhibitors
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
Ch
an
ge
fro
m b
as
elin
e in
6 M
WD
0
0.2
0.4
0.6
0.8
1
0 14 28 42 56 70 84
Time in days
Pro
po
rtio
n f
ree
of
clin
ica
l w
ors
en
ing
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
ABOUT 80% OF THE SPINAL IMPLANT MARKET
IS IN THE UNITED STATES
36
France
D E F E N D A N T
Surgiview
OrthoTec
P L A I N T I F F
SPINAL IMPLANT PRODUCTS
37
38
FUSION PRODUCTS
SCS Claris Cerfix
39
EUROSURGICAL IS NEAR THE COURT OF ARRAS
PARIS:Surgiview
BEAURAINS:Eurosurgical
ARRAS:Court
F R A N C E
40
July 22, 2004
French Court appoints Meynetas 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’spurchase of
Eurosurgicalassets not owned
by OrthoTec
2004 2005 2006
41
Welcome
Johanna Shulman
Global Brand Director
Signifor (pasireotide)
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
Cushing’s SyndromeDiagnostic 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
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 testMeasure 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
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
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 serumtesting
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
Patient’s Frustrations and Societal Withdrawal Were Poignantly Illustrated Within Their Journals
Hig
h p
oin
tsP
ain
po
ints
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
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
At Month 6, the Majority of Patients Had a Reduction From Baseline in UFC
Patient
mU
FC
(nm
ol/24 h
)
0
500
1000
1500
2000
4000
7000
Pasireotide 600 µg bid Pasireotide 900 µg bidBaseline 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
50
0 10 20 30 40 50 60
>ULN to ≤2xULN
>2xULN to ≤5xULN
>5xULN to ≤10xULN
>10xULN
Patients achieving UFC ≤ULN (%)
Pasireotide 900 μg bid (N=80)
n=11
n=20
n=9
n=28
n=13
n=41
n=26
n=40
n=66
n=12
n=14n=26
Primary Efficacy EndpointSubgroup Analysis at 6 Months
Pasireotide 600 μg bid (N=82)Overall (N=162)
51
Shifts in Response Status From 6 to 12 Months
N=36(22.2%)
N=20(55.6%)
N=3(8.3%)
N=13(36.1%)
N=25(15.4%)
N=5(20.0%)
N=8(32.0%)
N=12(48.0%)
N=101(62.4%)
N=6(5.9%)
N=4(4.0%)
N=91(90.1%)
• Controlled
• Partially controlled
• Uncontrolled
52
Signifor VisionTo be the backbone of therapy for the treatment of pituitary and gastroenteropancreaticneuroendocrine 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
SI1Clearly Articulate the Benefits of Signifor Tx• Biochemical control• Tumor control• “Pituitary-directed”• “Pituitary-sparing”
SI2Differentiate From SomatostatinAnalogs & 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
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
2010 2011
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Reg
istra
tion
Mark
et R
ead
iness
Bra
nd
Stra
teg
y a
nd
C
PO
Read
iness
Countdown to Cushing’s Disease LaunchGlobal 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
PackagingValue 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
Cushing’s Regulatory Strategy Is Moving ForwardGlobal 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
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
Announce Cushing’s Data and Regulatory MilestonesPR 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 Republic24-28 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
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
20
10
Kic
k O
ff
Disease Awareness Objection Handler
Cx Assessments
Patient Case Series FlashcardsDisease State, Diagnosis
Representative Launch Training
ASM Coaching Guide
Annotated Clinical Reprint
Print-based
Competitive Flashcards
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
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 availableFIR
Region Europe/Italy Round Table
ENDO 19-22 Jun
San Diego, CA
ENEA 22-25 Sept
Liege, Belgium
ICE satellite
symposium
ECE satellite
symposium
Novartisevening 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
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
Pri
ce in
dex (
Jan
1996 =
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?
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
Pri
ce in
dex (
Jan
1996 =
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?
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
Pri
ce in
dex (
Jan
1996 =
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’s the Product at Issue?
64
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
What’s the Product at Issue?
66
Fluorescent Lights
Glass Plate
Electrodes
Liquid Crystal
Electrodes
Light Filter
Glass Plate
Defendants Operated in the U.S.
67
Taiwan
Korea
Japan
United States
Chunghwa
SDI
Motorola’s Single Global Price
68
SDI
Chunghwa
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
Pri
ce
in
de
x (
Jan
19
96
= 1
00
)
Small TFT panel actual price index
But-for price index (conspiracy period)
But-for price index (plea period)