OIS 2014 Year in Review
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Transcript of OIS 2014 Year in Review
2014 – The Year in Review
Emmett Cunningham M.D., Ph.D., M.P.H.
Partner, Clarus Ventures, LLC
Save the Dates
7th Annual OIS@AAOLas Vegas, NevadaNovember 12th, 2015
4rd Annual OIS@ASCRSSan Diego, CaliforniaApril 16th, 2015
HASHTAG: #OISAAO
6th Annual OIS@AAO> 750 Attendees; 32 States & 22 Countries
29%
30%
7%
19%
15%
Corporate / Strategic Executive
Private Company Executive
Investment Professionals
Physician / Clinician
Media / Press / Consultants
OIS@AAO Advisory Board
K. Angela MacfarlaneForSight Labs
Sabri Markabi, MDAlcon
James MazzoAcuFocus
David W. Parke, MDAAO
Jane RadyAbbott Medical Optics
Calvin Roberts, MDBausch + Lomb
Murthy V. Simhambhatla, PhDAbbott Medical Optics
Richard L. Lindstrom, MDMinnesota Eye Consultants
Anthony P. AdamisGenentech
Mark S. Blumenkranz, MDStanford University
Eugene de Juan, MDForSight Labs
Andy CorleyYelroc
Malvina B. Eydelman, MDFDA
David R. Guyer, MDOphthotech
David KarcherASCRS
Michael Kaschke, MDCarl Zeiss
William J. Link, PhDVersant Ventures
Gilbert H. Kliman, MDInterWest Partners
Emmett T. Cunningham, MD, PhD, MPHClarus Ventures
Ellen Strahlman, MD, MHScBecton Dickinson
Scott M. Whitcup, MDAllergan
George Yancopoulos, MD, PhDRegeneron
Co-Chairs:
HASHTAG: #OISAAO
Drugs
0
20
40
60
80
100
120
140
19
88
19
89
19
90
19
91
19
92
19
93
19
94
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95
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96
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19
98
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99
20
00
20
01
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20
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20
04
20
05
20
06
20
07
20
08
20
09
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10
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11
20
12
20
13
20
14
Total Ophthalmic Approvals Total Approvals
Linear (Total Ophthalmic Approvals) Linear (Total Approvals)
Original NDA/BLA Approvals – 1988 to 2014Center for Drug Evaluation and Research
Data provided by :
Wiley A. Chambers, MDSupervisory Medical OfficerDivision of Transplant and Ophthalmology Products
• Range: 0 – 9• Mean: 4.4• Median: 4
Ophthalmic / Year: Stable
Original NDA/BLA ApprovalsCenter for Drug Evaluation and Research - FY2014
Data provided by :
Wiley A. Chambers, MDSupervisory Medical OfficerDivision of Transplant and Ophthalmology Products
October 1, 2013 thru September 30, 2014• Travoprost ophthalmic solution (IZBA®), 0.003%, for the reduction of elevated intraocular
pressure in patients with open-angle glaucoma or ocular hypertension, May 15, 2014 (NDA) – Alcon.
• Phenylephrine and ketorolac injection (Omidria®), 1% / 0/3%, to be added to an
ophthalmic irrigation solution used during cataract surgery or intraocular lens replacement; indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain, June 2, 2014 – Omeros
• Atropine ophthalmic solution, 1%, for cycloplegia, mydriasis and penalization of healthy eye
in the treatment of amblyopia, July 18, 2014 – Akorn
• Fluocinolone acetonide intravitreal insert (Iluvien®), 0.19 mg, for the treatment of
diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure, September, 29, 2014, Alimera Sciences
3.8% Ophthalmic
102
4
0
20
40
60
80
100
120
Ophthalmic
Non-Ophthalmic
Noteworthy Approvals …
Fluocinolone acetonide intravitreal insert (Iluvien®), 0.19 mg
FDA Approved, September, 29, 2014
EU Approved, 2012
Fluocinolone acetonide
Global Diabetic Macular Edema Patients
16.9% CAGR - Treated
•Improved Access to
Care
•New Products
0
5
10
15
20
25
30
2013 2020
Rest of World
Latin America
India
China
Other Wealthy Nations
Japan
Western Europe
United States
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
27 M
23 M
2.5% CAGR
FAME Study Efficacy: Percentage of Patients With ≥ 15-Letter Improvement (Pooled Data)
Primary readout
28.7%
16.2%
P = .002
Campochiaro PA, et al. Ophthalmol. 2011;118:626-635; Campochiaro PA, et al. Ophthalmol. 2012;119:2125-2132. ILUVIEN Prescribing Information.
0
5
10
15
20
25
30
35
40
0 3 6 9 12 15 18 21 24 27 30 33 36
Control (n = 185)
0.2 µg/d FAc (ILUVIEN; n = 376)
> 15 Letters (%)
Cataract
IOP
Approved Dose
Global Ophthalmic Pharmaceutical Market Revenues by Specialty
7.910.3
4.3
5.02.8
3.63.9
4.1
0
5
10
15
20
25
2014 2019
Rev
enu
es B
illio
ns
US$
All Other
Dry Eye
Glaucoma Pharmaceuticals
IVT Anti-VEGF (AMD, DME, RVO, Etc.)
$18.9 Bn
$23.0 Bn
CAGR
0.5% Other
5.4% Dry Eye
3.1% Glaucoma
5.6% Anti-VEGF
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
IVT Injections….
Courtesy Dr. Peter Karth and Dr. Marc Blumenkranz
-
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
14,000,000
16,000,000
18,000,000
2006 2007 2008 2009 2010 2011 2012 2013 2014
US OUS Total
Global IVT a – VEGF Injections
IVTa – VEGF Injections
Source: Market Scope Estimates Market Scope ®
16.4M
12.2M
4.2M
Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
Most Growth OUS
IVT Injection vs Cataract ProceduresUSA , 2001 – 2016E
Williams GA. IVT injections: health policy implications. Review of Ophthalmology 2014; June:62-64.
IVT Injection > 2x Cataract
Wet AMD
Anti-VEGF for nAMD, DME, RVO
Market Scope ®
US Retina Specialist Treatment for Wet AMD
Usage Stable
Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
2Q2013 2Q2014
Similar to abflibercept, conbercept (KH902; ChengduKanghong Biotech Co., Ltd., Sichuan, China) consists ofThe VEGF binding domains of the human VEGFR-1 andVEGFR-2 combined with the Fc portion of the humanImmunoglobulin….
Approved in ChinaDecember 6, 2013
Conbercept(Lumitin®)
(朗沐)
FovistaTM Phase 3 TrialsIn Wet AMD
Actively Recuriting
Fovista 1.5mg + Lucentis (N=311) Consistent w/Lucentis dosing schedule Q4W approved in EU*
Lucentis 0.5mg (N=311) Consistent w/Lucentis dosing scheduleQ4W approved in EU*
OPH1002N = 622
Year 1
Fovista 1.5mg + Lucentis (N=311) Q8W (pre-specified PRN therapy during Q4W non-treating months)
Lucentis 0.5mg (N=311) Q8W (pre-specified PRN therapy during Q4W non-treating months)
Fovista 1.5mg + Avastin 1.25mg /Eylea 2mg (N=311) Avastin: Q4W / Eylea: Q8WAvastin Q4W / Eylea Q4W for 3 months, then Q8W
Avastin 1.25mg / Eylea 2mg (N=311) Avastin Q4W / Eylea Q8WAvastin Q4W / Eylea Q4W for 3 months, then Q8W
Year 2
OPH1003N = 622
OPH1004N = 622
PrimaryEndpoint
DME
Courtesy Dr. David Sarraf
ScreeningHigh Risk PDR (71A)
Month 36Mild NPDR (35E)
24 Months - Ranibizumab:
• ~36% 2-Step improvement in
EDTRS DR severity
• ~ 3 Fold reduction in
progression to PDR
sBLA submitted August 7, 2014Action date February 6, 2015 (Priority Review)
Dry AMD
IVT Lampalizumab (Anti-Factor D Fab - 10mg) For Geographic Atrophy
Rate limiting enzyme in alternative complement cascade
Factor D
Anti-Factor D Fab
Phase 2 RCT (129 pts)
CFI + Biomarker44% Reduction in GA growth
CFI - BiomarkerNo Apparent Reduction in GA growth
IVT Lampalizumab(Anti-Factor D Fab)
For Geographic Atrophy
Sham
injection
Q4 weeks
10 mg
lampalizumab
Q6 weeks
10 mg
lampalizumab
Q4 weeks
Phase III GA populationN = 936 per study
Randomized 2:1:2:1
Sham
injection
Q6 weeks
N = 312CFI+: 188CFI: 124
N = 156CFI+: 94CFI: 62
N = 312CFI+: 188CFI: 124
N = 156CFI+: 94CFI: 62
‘Chroma’ and ‘Spectri’ Global Phase 3 TrialsActively Recruiting
Phase III Trials
Opus-2 and Sonata Phase 3 Results of Lifitegrast 5.0%
for Dry EyeTo be Submitted to the
FDA 1Q2015
> 1800 Patients
Lifitegrast 5.0%LFA Inhibitor
Dry Eye
Corneal Staining
Phase 2 Dry Eye Data*
39% Change from Baseline in Sign
Mean Change in Total CFS (EE50 Population)
CF
S C
hang
e fr
om B
asel
ine
Weeks on Treatment
61% Change from Baseline in Symptom
Vehicle Control (n=15)
Combined EBI-005 Treatment (n=20)
Mean Change in Score on Painful or Sore Eyes OSDI Question (EE50 Population)
Weeks on Treatment
Pai
n C
hang
e fr
om B
asel
ine
* Not statistically significant at 6 weeks
Receptor
EBI-005
Phase 3 Dry Eye Trials Recruiting(data 1H2015)
Positive Phase 2 data inAllergic Conjunctivitis†
Topical IL-1R Blocker
†Secondary and Exploratory Endpoints
EBI - 005
Humira®
(Adalimumab)
International Phase 3 Studies Recruiting in Non-Infectious Intermediate, Posterior, and
Panuveitis / Behcet’s Disease
IgG1 Fc
Fab
Anti - TNFa
Gevokizumab ( anti-IL-1b ) Non-Infectious and Behcet’s Uveitis
Four Phase 3 Trials Actively Recruiting• > 700 patients • Active and Controlled
Non-Infectious intermediate, posterior, and panuveitis
• Active and Controlled Behcet’s Disease
• Data 1H2015
RhopressaTM
Triple MOAROCKi /NETi, EVP Reduction
Data mid-2015
Phase 2b (221 Patients)0.01% Rhopressa TM vs 0.02% Rhopressa TM vs Latanoprost
Majority of Glaucoma Patients
RhopressaTM & LatanoprostClinically and
Statistically Equivalentat Days 14 and 28
Pre-Specified Subgroup Analysis
Baseline Day 14 Day 28 Baseline Day 14 Day 28
Phase 3 Studies Recruiting
15.0
17.0
19.0
21.0
23.0
25.0
27.0
Diurnal Average IOP (Entire Cohort; Entry IOP 22-36 mmHg)
( n = 221 )
0.01% AR-13324 0.02% AR-13324 Latanaprost
15.0
17.0
19.0
21.0
23.0
25.0
27.0
Diurnal Average IOP (Moderate IOP; Entry IOP 22-26 mmHg)
( n = 106 )
0.01% AR-13324 0.02% AR-13324 Latanaprost
Gene Therapy in Ophthalmology At the Tipping Point ?
Sisyphus Snowball
Tipping Point
Devices
0
20
40
60
80
100
120
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
510(k) Original and Panel Track PMA
Linear (510(k)) Linear (Original and Panel Track PMA)
Original 510(k) & PMA Received – 2004 to 2014Center for Devices and Radiological Health
Data provided by :Malvina B. Eydelman, MDDirectorDivision of Ophthalmic, and Ear, Nose and Throat Devices, FDA
• Range: 1 – 9• Mean: 4.2• Median: 4
PMAs Stable
• Range: 53 - 104• Mean: 70• Median: 63
510(k)s Increasing
3.1% of Total
Data provided by :Malvina B. Eydelman, MDDirectorDivision of Ophthalmic, and Ear, Nose and Throat Devices, FDA
2414
76
0
500
1000
1500
2000
2500
Ophthalmic
Non-Ophthalmic
510(k) ClearancesCenter for Devices and Radiological Health - FY2014
5.6% of Total
October 1, 2013 thru September 30, 2014• ReSure® Sealant, for use in stopping fluid from leaking through the incision in a
patient’s cornea after cataract surgery with intraocular lens placement in adults –Ocular Therapeutix.
Data provided by :Malvina B. Eydelman, MDDirectorDivision of Ophthalmic, and Ear, Nose and Throat Devices, FDA
17
1
0
2
4
6
8
10
12
14
16
18
20
Ophthalmic
Non-Ophthalmic
PMA ApprovalsCenter for Devices and Radiological Health - FY2014
Noteworthy Approvals …
Clinical Trial Results:
• Superiority over sutures for prevention of wound leaks (p<0.0001)
• Significantly less AEs in ReSure group vs. suture group (p<0.0001)
• Well tolerated
• Commercial launch 1Q2014
FDA ApprovedJanuary 8, 2014
4.1%
34.1%
0%
10%
20%
30%
40%
50%
ReSure Sealant(n=295)
Suture(n=176)
Leak Rate (PMA)
* P<0.0001
HeliosTM Insert
Punctal Plug
Punctal Plug
Sustained ReleaseDrugs for Glaucoma
Funding
$651$665 $660 $666
$670
$688$706 $701 $702
$656
$674 $675
$820$810
$779$764
$740
$763$770
$741
$727
$670
$500
$550
$600
$650
$700
$750
$800
$850
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015E
NEI (Actual) NEI (2014$)
NEI Funding Flat, but …Down ~25% after Inflation (2014$)
28% of RO1s Funded
Inflation Calculatorhttp://data.bls.gov/cgi-bin/cpicalc.pl
Data provided by :
Matthew McMahon, Ph.D.Director, Office of Translational Research, NEI
$0
Source: PricewaterhouseCoopers, Silicon Valley Bank
Total VC vs BioPharma vs Medical Device Investments (2000-2013)
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
$-
$10
$20
$30
$40
$50
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Bill
ion
s
Total VC $ BioPharma Device
$99 Bn Healthcare ~ $4Bn
Courtesy Jon Norris, SVB
Lifescience Venture Capital Funding Gap
$6.0
$7.3
$9.1
$8.6
$6.6 $6.3
$7.7
$6.7
$6.7
$3.4
$6.6
$7.9
$6.1
$5.2
$1.8
$3.7 $3.6
$3.9
$0.0
$1.0
$2.0
$3.0
$4.0
$5.0
$6.0
$7.0
$8.0
$9.0
$10.0
2005 2006 2007 2008 2009 2010 2011 2012 2013
Invested ($Bn)Fundraised ($Bn)
Source: PricewaterhouseCoopers, Silicon Valley Bank Courtesy Jon Norris, SVB
$2.8 Bn(1.7x Gap)
0
100
200
300
400
500
600
0
5
10
15
20
25
30
Total D
ollars In
veste
d ($
M)
Nu
mb
er
of
Ve
ntu
re D
eal
s fo
r D
rug
and
Dev
ice
# Rx Deals # Device Deals VC Investment ($USD, Millions)
business intelligence*2014 figures through SeptemberSOURCE: Strategic Transactions
Ophthalmic Investments by VCs Over Time1999 – 2014*
VC Funding Stable• ~ $400M / year• 15 – 20 deals
VC Investment By Ophthalmic Indication (1999-2014*)
*2014 figures through SeptemberSOURCE: Strategic Transactions
47
36
2118
12 118 7
12
73 4
0
5
10
15
20
25
30
35
40
45
50
0
100
200
300
400
500
600
700
800
900
1,000
1,100
1,200
Nu
mb
er of D
eals
Pri
vate
Pla
cem
ents
($
M)
Dollars ($ Millions) Number of deals
“One final question…Are we merging or are they?”
$600M
Undisclosed
$160M
$8M upfrontUp to $640M
0%
20%
40%
60%
80%
100%
120%
2006 2007 2008 2009 2010 2011 2012 2013
Biopharma
Non-Structured Structured
0%
20%
40%
60%
80%
100%
120%
2005 2006 2007 2008 2009 2010 2011 2012 2013
Device
Non-Structured Structured
Staged Buy-Outs Continue to beCommon for Private Companies
Courtesy Jon Norris, SVB
~50% ~80%
50%
100%
150%
200%
250%
300%
350%
400%
450%
2004 2006 2008 2010 2012 2014
10-year Stock Price Performance
53%
292%
Source: FactSet as of 09/16/141 Medtech index consists of medical technology companies traded on North American exchanges with market capitalizations over $1bn
78%
Returns summary
10 yr 5 yr YTD
Medtech1
63%
Biotech235%
S&P 50087%
16%
19%
9%
Best Three Years for Biotech in a Decade
Ophthalmology IPO MarketMost Active in 15 Years
2
0 0 0
4
1 1
2
0 0
2
9
0
100
200
300
400
500
600
700
0
1
2
3
4
5
6
7
8
9
10
2000 2001 2002 2003 2004 2005 2006 2010 2011 2012 2013 2014
Total Raised ($M) # of deals
# $M
Courtesy Tom SalemiExcludes 2002 Alcon IPO
IPOs In Ophthalmology –The Class Of 2014 & Beyond
Susan WasherPresident & CEO
AGTC
Vicente Anido, Jr., PhD CEO
Aerie Pharmaceuticals
Amarpreet Sawhney, PhD President and CEO Ocular Therapeutix
Brian Johnson Partner
WilmerHale
Thomas W. Chalberg, PhD Founder & CEO
Avalanche Biotechnologies
Michael Gaito Managing Director,
Head of West Coast Life Sciences J.P. Morgan
David R. Guyer, MDCEO
Ophthotech
MODERATOR
Industry Consolidation: The Good, The Bad & The Unknown
Jeff George President & Global Head
Alcon
William J. Link, PhD Managing Director Versant Ventures
David E.I. PyottCEO
Allergan
Murthy V. Simhambhatla, PhD President
Abbott Medical Optics
Ashley McEvoyCompany Group Chairman
Johnson & Johnson Vision Care
James Mazzo Chairman & CEO
AcuFocus
MODERATOR
Please Watch the Clock . . . .
ADDITIONAL SLIDES
Cataract, RLE, Phakic IOLs-23.4M
44%
Laser Refractive 3.3M6%
IVT Injections 16.5M31%
Laser Photocoagulation 1.9M
4%
Vitrectomies 1.4M3%
Glaucoma Laser 2.1M
4%
Glaucoma Filtering, Shunts, etc. 0.6M
1%
All Other 3.7M7%
Global Ophthalmic Procedures2014 (53.0 M)
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
0
5,000
10,000
15,000
20,000
25,000
30,000
2013 2019
Tho
usa
nd
s o
f P
roce
du
res
(ey
es)
Conventional Phaco Femto Laser Plus Phaco (FLCS) ECCE & Other
FLCS (2.0%)
FCLS (8.4%)
Total Phaco 66.4%
Total Phaco 70.1%
ECCE / OTHER 21.5%
ECCE / OTHER 31.6%
Global Cataract/RLE Procedures by Equipment Technology
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
0
500
1,000
1,500
2,000
2,500
2014 2019
Tho
usa
nd
s o
f P
roce
du
res
(ey
es)
Femto Laser PlusPhaco (FLCS)
Forecast 2014-2019 CAGR 36.5%
Expected 2013-2014 Growth 50.8%
Global Femtosecond Cataract Surgery Procedures
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
450K
2.1M
64 64 62
44 4654
20
42
255
0
50
100
150
200
250
300
2013 2014 (Forecast) 2019 (Forecast)
US
Gla
uco
ma
Su
rger
ies
(00
0)
Filtration Tube Shunts MIGS
US Glaucoma Surgical Procedures
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
0
200
400
600
800
1,000
1,200
1,400
2013 2014 2015 2016 2017 2018 2019
Tho
usa
nd
s o
f P
roce
du
res
(ey
es)
ATGS Procedures
Shunts
Filtering Surgery
Global Glaucoma Procedures(Excluding Laser Procedures)
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
690K
114K
341K
Biotech IPO Window Open, but Average Return Dropping
14
41
79
0
10
20
30
40
50
60
70
80
90
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
2012 2013 2014
Total Cumulative $s Raised
# of Offerings
$M
Avg. Raise• 2012: $65.7M• 2013: $75.3M• 2014YTD: $65.9M
Avg. Mkt Cap• 2012: $341.9M• 2013: $374.7M• 2014YTD: $263.1M
Avg. Return: 45%* 49% 2%*Excluding extreme outliers:Puma Biotechnology (1331%) and Intercept Pharmaceuticals (1418%)
As of 10/9/2014Courtesy Doug Fisher
Phase III Trials