coherus biosciences - jefferies · litigation reform act of 1995, including coherus’ expectations...
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2 Copyright ©2015 All Rights Reserved. |
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this presentation, including statements
regarding Coherus’ plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies,
product pipeline, clinical studies, product development, release of data and the potential benefits of its products under
development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995, including Coherus’ expectations regarding its ability to advance its CHS-1701,CHS-0214,
and CHS-1420 biosimilar drug candidates, recruit patients in biologic license application enabling studies for CHS-1701,
complete its Phase 3 clinical development of CHS-1420 and develop its pipeline. Such forward-looking statements involve
substantial risks and uncertainties that could cause our clinical development programs, future results, performance or
achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the
regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or
commercial potential of our biosimilar drug candidates. Coherus undertakes no obligation to update or revise any forward-
looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see
Coherus’ Quarterly Report on Form 10-Q for the period ended September 30, 2015 and its future periodic reports to be filed
with the Securities and Exchange Commission.
3 Copyright ©2015 All Rights Reserved. |
Agenda
• Company and Opportunity
• Development Pathway and Platform
• Pipeline Status and Activity
4 Copyright ©2015 All Rights Reserved. |
Coherus BioSciences: A Leading Pure Play Biosimilars Company
• Three products in Phase 3 or BLA-enabling trials
• Three BLA/MAA filings targeted within next two
years aimed at worldwide market opportunity of
$24bn in 2017
• Expect to submit at a minimum one new IND per
year from a range of originator drugs coming off
patent
Pipeline Significant Experience in Pioneering
Biologics Companies
Partners
Etanercept: EU, Brazil,
Canada, China Etanercept: Japan
Name Prior Experience
Denny Lanfear President and CEO
Jean Viret, Ph.D. Chief Financial Officer
Alan Herman, Ph.D. Chief Scientific Officer
Barbara Finck, M.D. Chief Medical Officer
Peter Watler, Ph.D. Chief Technical Officer
Michael Fleming SVP, Commercial Strategy
Aaron Schuchart SVP, Business Development
5 Copyright ©2015 All Rights Reserved. |
Converging Trends Create a Significant Near-Term
Global Market Opportunity for Biosimilar Development
~$108 Billion In 2014 Originator
Global Sales
Healthcare Reform/
Regulatory Enablement
Payer Need for
Biologics Cost Control
Surge in 2012 – 2017
Patent Expirations
Better Analytic Tools
Enable Comparability
Source: EvaluatePharma: 30 originator products with > 1 $Bn in global sales losing patent exclusivity in at least one major market through 2020 had ~$108 billion in 2014 global sales
6 Copyright ©2015 All Rights Reserved. |
Over $108 Billion in Pipeline Candidate Selection
Opportunities
Source: EvaluatePharma. Represents biologics with 2014 WW sales of greater than $1bn
Brand Generic 2014 WW Sales ($mm)
Humira adalimumab $12,543
Enbrel etanercept 8,538
Lantus insulin glargine recombinant 8,428
Remicade infliximab 8,162
Rituxan rituximab 7,547
Avastin bevacizumab 7,018
Herceptin trastuzumab 6,863
Neulasta pegfilgrastim 4,596
Lucentis ranibizumab 4,301
NovoRapid insulin aspart recombinant 3,109
Avonex interferon beta-1a 3,013
Humalog insulin lispro recombinant 2,785
Levemir insulin detemir recombinant 2,533
Rebif interferon beta-1a 2,444
Advate factor VIII (procoagulant) 2,348
Botox onabotulinumtoxinA 2,231
Synagis palivizumab 2,169
Epogen epoetin alfa 2,031
Tysabri natalizumab 1,960
Erbitux cetuximab 1,924
Xolair omalizumab 1,843
NovoMix 30 insulin: insulin aspart 1,759
Orencia abatacept 1,652
Kogenate octocog alfa 1,473
Pediarix DTP, hepatitis B & polio vaccine 1,364
Procrit epoetin alfa 1,238
Norditropin SimpleXx somatropin recombinant 1,159
Neupogen filgrastim 1,159
Pegasys peginterferon alfa-2a 1,110
Actemra Toclizumab 1,105
• Thirty originator products
• Each with >$1 billion in 2014 WW sales
• Losing or lost patent exclusivity in at
least one major market through 2020
• Total ~ $108 billion in 2014 WW sales
• Coherus’s pipeline
• Three in late stages of development
• At least three earlier stages of
development
• Ample substrate
• For further candidates using the
Coherus platform
7 Copyright ©2015 All Rights Reserved. |
CHS-1701 (pegfilgrastim
Biosimilar)
CHS-0214 (etanercept
Biosimilar)
CHS-1420
(adalimumab
Biosimilar)
Regulatory
Data
Other
3Q ‘15 4Q ‘15 1Q ‘16 2Q ‘16 3Q ‘16 4Q ‘16
1Q ‘16 – Anticipates submitting BLA
4Q ‘15: – Projects completion of dosing for Immunogenicity study
10/1/15: Announced positive data from PK/PD study
Late Stage Wave 1 Pipeline and Anticipated
Milestones
3Q ’15: Initiated Ph 3 Psoriasis study
1H ’16: Plans to initiate PK study
2H ’16: Anticipates
submitting BLA
Projected milestones placed at midpoints of achievement windows
4Q ’15: Expects data from Ph 3 Psoriasis study
1Q ’16: Expects data from Ph 3 RA study 2H ’16: Anticipates
submitting MAA
8 Copyright ©2015 All Rights Reserved. |
CHS-1701 Pegfilgrastim Biosimilar:
Near Term Commercial Opportunity & Value Driver
Market &
Commercial
Molecular/
CMC
Scientific/
Clinical
Legal
Financial
Relatively
modest
competition
Strong existing
CHRS scientific
knowledge base
Well defined
mechanism of
action
Patent
expirations
appear clear
Near term
launch to fund
wave 2 pipeline
Reasonably
sized
commercial
footprint
Complex but
well defined;
limited
heterogeneity
Clear efficacy
end point
Excellent
antigenicity
profile
Line extension
strategy
expiration
Potentially
substantial
revenue
opportunity
Relatively
stable
treatment
paradigm
Existing
formulation
stable, available
Executable
and
reasonably
sized studies
Relatively well
controlled
“moderate”
Low
manufacturing
cost of goods
9 Copyright ©2015 All Rights Reserved. |
Growth in Biologics Spend Puts Biosimilars
Firmly on Payer Radars
Biologic agents expected to represent 19-
20% of the total market value by 2017
Biologics Landscape
Source: IMS Health; Credit Suisse research; Evaluate Pharma
Total Global Biologics Spend
$46
$106
$169
$221
$0
$50
$100
$150
$200
$250
2002 2007 2012 2017
US
$ in
Bill
ions
Anti-TNF Pricing History
100%
120%
140%
160%
180%
200%
220%
Jan-09 Jan-10 Jan-11 Jan-12 Jan-13 Jan-14 Jan-15
WA
C G
row
th f
rom
20
09
Ba
se
line
Humira 40mg Kit Enbrel 25mg Prefilled SyringeRemicade 100mg Vial
PI since 2009
+201%
+188%
+154%
Aggressive US price increases have become
a major growth driver of biologic spend
10 Copyright ©2015 All Rights Reserved. |
Collaboration Opportunities
• Educational programs
• Consultation on Phase 3
design to deliver data required
by Pharmacy & Therapeutics
Committees
• Joint public affairs outreach
Many Leading Payers Have Signaled Strong
Support and Willingness to Cooperate
We share a joint commitment
with companies like Coherus to
create a vibrant biosimilars
market place.
− Steve Miller,
SVP & Chief Medical Officer,
Express Scripts
“ “ Some Payers Have Publicly Expressed Their Interest
in Biosimilars and Intent to Drive Adoption
11 Copyright ©2015 All Rights Reserved. |
Agenda
• Company and Opportunity
• Development Pathway and Platform
• Pipeline Status and Activity
12 Copyright ©2015 All Rights Reserved. |
Originator Heterogeneity Creates Significant
Challenges and Determines Market Characteristics
Small Molecule
GENERIC BIOSIMILAR
Complex Biologic
Heterogeneity
• Observed between manufacturing plants, among
batches and within single vials
• Characterized with ranges, not absolutes
• Biosimilarity is defined by originator variability
IMPLICATIONS
• Higher Entry Barriers
– More sophisticated
skills
– Complex technological
base
– Larger investments for
longer time
• Extended Development
• Fewer Competitors
• Relatively Stable Pricing
13 Copyright ©2015 All Rights Reserved.
0 20 40 60 80
0
10
20
30
40
50CHS0214_Lot 133-002-12-290028 (GR. 2)
Enbrel_lot G47931_EU2 (GR. 10)
Enbrel_Lot 1033363_US1 (GR. 6)
Time (hr)
Co
ncen
tra
tio
n
( g/m
L)
Demonstrating Biosimilarity: Established Five Step Process
Platform: Navigating the pathway to approval
0 48 96 144 192 240 288 336 384 432 480
1
2
3
4
5
CHS-0214 DP
Enbrel (EU)
Time (hr)
Co
ncen
trati
on
( g/m
L)
0 48 96 144 192 240 288 336 384 432 480
1
2
3
4
5
CHS-0214 DP
Enbrel (EU)
Time (hr)
Co
ncen
trati
on
( g/m
L)
Cell Line Development
and Manufacturing
Analytical Characterization
and in vitro Comparability
In vivo Animal
Comparability
Pivotal Phase 1
Human PK/PD
Study
Phase 3
Clinical
Trials
Cutting Edge Analytics
Intellectual
Property
Clinical and Regulatory
Process Science and Molecular
Tuning
14 Copyright ©2015 All Rights Reserved.
Platform Sophisticated Analytics Define Originator Ranges
Clinical and Regulatory
Cutting Edge Analytics
Internal Capability is Essential
Biosimilar to What?
15 Copyright ©2015 All Rights Reserved.
Platform: Process Science and Cell Biology Molecular tuning is validated in non-clinical models
Process
Process Science and Molecular
Tuning 0 20 40 60 80
0
10
20
30
40
50CHS0214_Lot 133-002-12-290028 (GR. 2)
Enbrel_lot G47931_EU2 (GR. 10)
Enbrel_Lot 1033363_US1 (GR. 6)
Time (hr)
Co
ncen
tra
tio
n
( g/m
L)
Intracellular metabolism directly impacts glycosylation and
biologic actively at various scales
Clinical and Regulatory
16 Copyright ©2015 All Rights Reserved.
Platform: Clinical and Global Regulatory Clarify Requirements, Mitigate Regulatory Risk
ENBREL
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
2012 2013
J J A S O N D J F M A
2013 2014
M J J A S O N D J F M
Guidance on
two
harmonized
clinical
programs
Advised one
program on
351(a)
Advised one
program to go
from 351 (a) to
351(k)
EU National scientific advice
for one product plan
EU National scientific advice
for second product plan
PMDA consultation
on product plan for
Japan
FDA BSUFA Type 2
meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2 meeting
for Product Development Plan
PMDA consultation
On product plan for Japan FDA BSUFA Type 2
Meeting for Clinical
Development Plan
EMA Central Advice and
FDA BSUFA Type 2
meeting for Product
Development Plan
Guidance on two
harmonized clinical programs
Advised one
program on
351(a)
Advised one
program to go
from 351(a)
to 351(k)
EU National scientific
advice for one product plan
EU National
scientific advice
for second product plan
17 Copyright ©2015 All Rights Reserved.
Platform Scientific Expertise Focused on Intellectual Property
Intellectual
Property
Scientific Advisory Board
Name Role Expertise Prior Experience
Bryan Lawlis, Ph.D. Chairman Process Sciences
Biochemistry
Andy Jones, Ph.D. Member Protein Chemistry
Glycobiology
Bill Bennett, Ph.D. Member Protein Chemistry
Regulatory
John Carpenter, Ph.D. Member Protein Formulation,
Aggregation
James Miller, Ph.D. Member Protein Chemistry
Carl Ware, Ph.D. Member Inflammatory Disease
Clinical and Regulatory
18 Copyright ©2015 All Rights Reserved. |
Platform Scientific Expertise Focused on IP Risk Mitigation
Intellectual property presents potential barriers to entry
Patent
Landscape
Assessment
• Comp of Matter
• Indications
• Formulation
• Process
• Dosing
Scientific
Advisory
Board
• Reference
Experts
• Industry
Knowledge
• Technical
Assessment
• Feasible
Alternatives
Innovation
And
IP Creation
• Stable
Formulations
• Cost Effective
Processes
• Protein Structure /
Characterization
• Global Filings
Intellectual
Property
Clinical and Regulatory
19 Copyright ©2015 All Rights Reserved. |
Recent US Legal Biosimilar Pathway Developments
• Zarxio’s FDA approval (March, 2015) marks first biosimilar approval in the US
• Federal Circuit Court in Amgen v. Sandoz has now ruled on the “patent dance:”
– Fed Circuit ruling (July, 2015): The BPCIA patent dance is optional.
– Applicants that opt out of the dance must give 180 days prior launch notice.
– Fed Circuit refused further “en banc” review.
• Amgen and Apotex are now engaged in patent dance litigation.
– Two Apotex biosimilars at issue: (Biosimilars of Neulasta and Neupogen)
– Amgen has sued Apotex for patent infringement on several process patents.
• Other biosimilars currently going through the patent dance:
– Celltrion (Infliximab)
– Hospira (Epoetin alfa)
20 Copyright ©2015 All Rights Reserved. |
Further Adalimumab Legal Developments
• On November 5, 2015 AbbVie withdrew its EP patent (EP 1,406,656) covering an
RA dosing regimen of 40 mg bi-weekly.
– Patent was opposed by 15 parties; potent invalidity arguments public
– In its EP filings, AbbVie stated it will continue to pursue the same dosing regimen in a related EP filing
(a “divisional application”).
– We expect the divisional filing to be opposed by some or all of the same parties using essentially the
same arguments.
• On September 14, 2015 an AbbVie formulation patent was revoked in Europe.
• On June 26, 2015 Amgen filed two Inter Partes Review (“IPR”) petitions against
two of AbbVie’s U.S. formulation patents.
• On November 9, 2015, Coherus filed an IPR petition against AbbVie’s US patent
8,889,135 directed to a bi-weekly dosing regiment for RA.
21 Copyright ©2015 All Rights Reserved. |
IPR Timeline: Final Decision within 18 Months
IPR
Request
(“Petition”)
filed.
USPTO Decision
whether to proceed
(“institute”) must
occur within six
months
December
1, 2015
June 1,
2016
Final decision by
USPTO (must
occur within 12
months of
institution)
June 1,
2017
Notes:
1. IPR may take less than 18 months, but not longer.
2. Appeal to Federal Circuit is possible. However, Fed. Cir. has rarely reversed PTO final
decisions (one instance).
3. Challenger’s burden to prove invalidity is easier than in District Court.
Example
22 Copyright ©2015 All Rights Reserved. |
Agenda
• Company and Opportunity
• Development Pathway and Platform
• Pipeline Status and Activity
23 Copyright ©2015 All Rights Reserved. |
Good Early Stage Pipeline Candidate Selection
Opportunities
Source: EvaluatePharma. Represents biologics with 2014 WW sales of greater than $1bn
Brand Generic 2014 WW Sales ($mm)
Humira adalimumab $12,543
Enbrel etanercept 8,538
Lantus insulin glargine recombinant 8,428
Remicade infliximab 8,162
Rituxan rituximab 7,547
Avastin bevacizumab 7,018
Herceptin trastuzumab 6,863
Neulasta pegfilgrastim 4,596
Lucentis ranibizumab 4,301
NovoRapid insulin aspart recombinant 3,109
Avonex interferon beta-1a 3,013
Humalog insulin lispro recombinant 2,785
Levemir insulin detemir recombinant 2,533
Rebif interferon beta-1a 2,444
Advate factor VIII (procoagulant) 2,348
Botox onabotulinumtoxinA 2,231
Synagis palivizumab 2,169
Epogen epoetin alfa 2,031
Tysabri natalizumab 1,960
Erbitux cetuximab 1,924
Xolair omalizumab 1,843
NovoMix 30 insulin: insulin aspart 1,759
Orencia abatacept 1,652
Kogenate octocog alfa 1,473
Pediarix DTP, hepatitis B & polio vaccine 1,364
Procrit epoetin alfa 1,238
Norditropin SimpleXx somatropin recombinant 1,159
Neupogen filgrastim 1,159
Pegasys peginterferon alfa-2a 1,110
Actemra Toclizumab 1,105
• Thirty originator products
• Each with >$1 billion in 2014 WW sales
• Losing or lost patent exclusivity in at
least one major market through 2020
• Total ~ $108 billion in 2014 WW sales
• Coherus’s pipeline
• Three in late stages of development
• At least three earlier stages of
development
• Ample substrate
• For further candidates using the
Coherus platform
24 Copyright ©2015 All Rights Reserved.
Coherus Applies Rigorous Selection Criteria to
Candidate Molecules
• Market Opportunity
• Patents & IP
Analysis
• Technical Analysis
• Molecule and
Analytics
• Cell line and
Manufacturing
• Clinical and
Nonclinical
• Harmonization
• Global Sites
• Co-therapies
• Payers / Providers
• Partners
• Patients
• Promotion
• Legal Defense
PRODUCT DECISION PATHWAY
1
2
3
Patent expiry
and large existing
markets are insufficient
rationale for product
selection
All technical and commercial factors must be
holistically evaluated at key decision points
25 Copyright ©2015 All Rights Reserved. |
• March 2015: Finalized the
Biologics License Application
(BLA) enabling clinical
program for CHS-1701 with
FDA
• No Phase 3 in patients
• Retention of global rights
CHS-1701 Development Timing and Milestones
Q2 ‘15
• PK/PD and Immunogenicity Studies Initiated
10/1/15 • Study Topline Data
Q1 ‘16 • BLA filing
26 Copyright ©2015 All Rights Reserved. |
• All four groups showed similar ANCmax
and ANC AUC
• Met bioequivalence for PD endpoints
CHS-1701 vs. Neulasta
Study Meets PD Endpoints, Performs as Expected
• Three out of four groups, including both
CHS-1701, performed as expected
• Demonstrated bioequivalence on Cmax
endpoint
• Period 1, Neulasta anomalous
27 Copyright ©2015 All Rights Reserved. |
CHS-0214 Development Timing and Milestones
RA FPI: Jun 2014
PsO FPI: Jul 2014
• Two ongoing Phase 3 clinical trials
in rheumatoid arthritis and psoriasis
• Phase 3 clinical trial requirements,
manufacturing strategies and
submission content discussed with
US, EU, and Japanese regulators
0 48 96 144 192 240 288 336 384 432 480
1
2
3
4
5
CHS-0214 DP
Enbrel (EU)
Time (hr)
Con
centr
atio
n
( g/m
L) z
Q2 ‘15
• Phase 3 PsO and RA Studies Enrolled
Q4 ’15 – Q1 ‘16
• Phase 3 Readouts
• Positive Ph 3 PsO Data
H2 ‘16 • MAA filing
28 Copyright ©2015 All Rights Reserved. |
• Initiated Phase 3 study in
psoriasis 2015
• Development plan reviewed with
regulatory authorities in United
States and Europe
z
CHS-1420 Development Timing and Milestones
Q3 ‘15
• Initiated Psoriasis Phase 3
MID ‘16
• Phase 3 Study Readout
H2 ‘16 • BLA filing
CHS-1420 SC 40 mg x 2 @
Week 0 / Day 0
40 mg QOW @ Weeks 1-15
N=250
Humira SC 40 mg x 2 @
Week 0 / Day 0
40 mg QOW @ Weeks 1-15
N=250
CHS-1420 SC 40 mg
QOW @ Weeks 17-23
N=250
CHS-1420 SC 40 mg
QOW @ Weeks 17-23
N=125
Humira SC 40 mg
QOW @ Weeks 17-23
N=125
Week 0 Week 16 Week 24
Treatment Period 1 Treatment Period 2
29 Copyright ©2015 All Rights Reserved. |
CHS-1701 (pegfilgrastim
Biosimilar)
CHS-0214 (etanercept
Biosimilar)
CHS-1420
(adalimumab
Biosimilar)
Regulatory
Data
Other
3Q ‘15 4Q ‘15 1Q ‘16 2Q ‘16 3Q ‘16 4Q ‘16
1Q ‘16 – Anticipates submitting BLA
4Q ‘15: – Projects completion of dosing for Immunogenicity study
10/1/15: Announced positive data from PK/PD study
Upcoming Wave 1 Catalysts
3Q ’15: Initiated Ph 3 Psoriasis study
1H ’16: Plans to initiate PK study
2H ’16: Anticipates
submitting BLA
Projected milestones placed at midpoints of achievement windows
4Q ’15: Expects data from Ph 3 Psoriasis study
1Q ’16: Expects data from Ph 3 RA study 2H ’16: Anticipates
submitting MAA
30 Copyright ©2015 All Rights Reserved. |
Company and Opportunity Summary
• Large opportunity
• Supportive, motivated payers seek
competition within >$100 billion market
• Experienced team
• Veteran team with past and present track
record of success
• Focused strategy
• Late stage products & near term revenue
• Market focused development platform to
deliver BLAs on best products
• Significant early stage pipeline
opportunities to fuel growth
~$108 Billion In 2014 Originator
Global Sales
Source: EvaluatePharma: 30 originator products with > 1 $Bn in global sales losing patent exclusivity in at least one major market through 2020 had ~$108 billion in 2014 global sales