KOL$event$ Building$a$successful$biosimilar$company - February 2019 - XBrane
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KOL$event$ Building$a$successful$biosimilar$company February 2019
INTRODUCTION
Laszlo'Bekesi Manfred'Weiler
AGENDA
• 10:00*+ 10:10*Introduction*(Anders*Tullgren)
• 10:10*– 10:35*Building*a*successful*biosimilar*company*(Manfred*Weiler)
• 10:35*– 11:00*Biosimilars*in*ophthalmology*(Laszlo*Bekesi)
• 11:00+11:15*Xbrane Biopharma*(Martin*Åmark)
• 11:15*– 11:30*QnA
INTRODUCTION TO)XBRANE BIOPHARMA
Our
strategy
Strategy
The only biosimilar developer with a commercialization partner on Develop high quality and cost efficient biosimilars
the lead candidate targeting Lucentis®
• Focusing on niched drugs with few competitors
• High yield technology platform leading to high margins
Xlucane Spherotide
Phase III • Establish local partnerships for sales and distribution
Karin Johannson Dina Jurman
Martin Åmark Anders Tullgren Maris Hartmanis Peter Edman
Wingstrand Head of
CEO Chariman Board Member Board Member
Board Member clinical affairs
AGENDA
• 10:00*+ 10:10*Introduction*(Anders*Tullgren)
• 10:10*– 10:35*Building*a*successful*biosimilar*company*(Manfred*Weiler)
• 10:35*– 11:00*Biosimilars*in*ophthalmology*(Laszlo*Bekesi)
• 11:00+11:15*Xbrane Biopharma*(Martin*Åmark)
• 11:15*– 11:30*QnA
11"OF"GLOBAL"TOP"15"DRUGS"ARE"BIOLOGICS
Biologics
6,25
Note:"IGEA
PRICE&PUTS&A&LIMIT&TO&BIOLOGICS&ACCESSABILITY
Rheumatoid'arthritis
Macular'degeneration Cancer
(TNFa inhibitors)
€5
BIOLOGICS(PUTS(A(HUGE(AND(INCREASING(BURDEN(ON(HEALTHCARE(SPEND
Global(pharmaceutical market(€(billion
1500
Biologics
Traditional
pharmaceuticals
1000
2% ”We know that biologics are used to treat many
serious and life-threatening diseases. They’ve
become a mainstay in the treatment of cancer and
500
autoimmune conditions.
They’re also expensive. While less than 2
percent of Americans use biologics, they
10% represent 40 percent of total spending on
prescription drugs.”
0
2011 2017 2022E
Scott Gottlieb, FDA Managing Director
Source:(IQVIA
BIOSIMILAR)DEVELOPMENT)DIFFERS)FROM)NOVEL)PRODUCTS)–
MORE)FOCUS)ON)PRECLINICAL)DEVELOPMENT)
+€1$billion €501100$million
+10$years 617$years
HISTORIC(OVERALL(SUCCESS(RATE(OF(APPROX.(95%(FOR(BIOSIMILARS(
ENTERING(PHASE(III
Launch
MAA/BLA
100%2(Europe)2and2
Phase III 70%2(US)2launched2
Europe:2442approvals
upon2patent2
US:2192approvals
expiration/readiness
EU:1.7% US:3%
3%REGULATORY*REQUIREMENTS*CLARIFIED*– 44*BIOSIMILARS*APPROVED*BY*EMA*
AND*19*BY*FDA (AS*PER*JANUARY*2019)
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
USD5.6B USD18B
1/0 3/0 5/0
1/0 2/0 3/1
0 0 6
USD7.2B USD7.2B
7*/0 4/0 2/0
2/2 3/1 1/1
0 4 6
USD8B USD4.6B
4*/0 2/0 5/1
1/0 1/0 2/2
2 4 2
USD7.6B USD1.7B
5/0 1/1
3/2 0/1
3 0
X EMA*approved/in*reg.*process USD0.8B USD8.1B
X FDA*approved/in*reg.*process 2 2/1
X In*Phase III*targeting Europe/US 0 1/2
0 5
Note:*2*filgrastim*biosimilars*withdrawn*from*market,**1*EPO*biosimilar*withdrawn*from*market*Source:(Company(information.BIOSIMILARS)ARE)FOLLOW)ON)PRODUCTS)TO)BIOLOGICS
Traditional*Pharma* Biologics*
Chemical*small*molecules Large*macromolecules
Generics Biosimilars
Originator*drugs Originator*drugs
After(loss(of(exclusivity After(loss(of(exclusivity
1*biosimilar at*21%*
9*generics at*90%*
discount
discount
12*generics at*90%* 2*biosimilar at*31%*
discount discount
7*generics at*90%* 5*biosimilar at*37%*
discount discount
Source:(Company(information.BIOSIMILAR,MARKET,EXPECTED,TO,GROW,AT,30%,FUELED,BY,STRONG,GROWTH,
DRIVERS
Global,biologics market,€,billion Strong'fundamental'growth drivers
400 10%
•1 Loss of exclusivity of originators: +EUR100bn to be
exposed 2022
300
•2 Regulatory clarity: 44 biosimilars approved in
Europe, 19 in US
200
•3 Payor, physician and patient adoption: Biosimilar
penetration on filgrastim up to 90% in Europe
100
0 30%
2011 2017 2022
Biosimilars Exposed Protected
Source:(BCC(research.(IQVIAADOPTION(AMONGST(PHYSICIANS,(PATIENTS(AND(PAYORS(DRIVE(FASTER(AND(
FASTER(BIOSIMILAR(PICK(UP
Average biosimilar penetration vs. originator
100%
GCSF Europe 91%
HGH Europe 8(years
EPO Europe
75% Infliximab Europe 67%
Etanercept Europe 9(years
Rituximab Europe
51%
GCSF (US) US
50% 3(years
50% 41%
3(years 8(years
26%
25%
2(years
11%
1(year
0%
0 1 2 3 4 5 6 7 8 9
Years after launch
Source:(IQVIAREMICADE(EXAMPLE:(BIOSIMILARS(HAVE(TAKEN(20730%(EACH(OVER(3(YEARS(
AND(MARKET(HAS(EXPANDED
Treatment days
130
+37%
110 22%
90 +29%
28%
70
50
30 48%
10
710 2010 2011 2012 2013 2014 2015 2016 2017
Source::(IQVIAORIGINATORS)USE)DIFFERENT)RESPONSE)STRATEGIES)TO)BIOSIMILARS
Patent)
Launch new)molecule Reformulation Compete on)price
litigations/extensions
Intravenous(to(subcutaneous( Europe
injection
Intravenous(to(subcutaneous(
injection
Note:)Dalton)is)the)unit)for)atomic)mass.)Source:(Company(information.MULTIPLE(INNOVATIVE(BIOSIMILAR(DEVELOPERS(HAVE(EMERGED
Innovative)developers Traditional generics companies Innovative)biologics players
+(Multiple local champions1.#Introduction
KEY#SUCCESS#FACTORS#FOR#BIOSIMILAR#DEVELOPERS
1 2
Cost efficiency in)development and)
Build the)right)capabilities
production
3 4
Pick)the)right)products Get)sales and)marketing)rightSUMMARY
• Biologics+efficacious+but+expensive+6 biosimilars)provides)cost)efficient)alternatives
• Biosimilar+market+is+growing)with)30%)p.a.+driven+by+loss+of+exclusivity,+regulatory+clarity+and+
increased+adoption
• Biosimilar+success)rates from+entering+phase+III+to+regulatory+approval+approx.)95%
• Biosimilar+penetration has+reached+up)to)90%)in+Europe+(Filgrastim)
• Active)deal)landscape)6 innovative+biosimilar+developer+license+out+to+big+pharma
• Biosimilar)developers)can)become)long)term)successful)focusing+on+building+the+right+
capabilities,+cost+efficient,+picking+the+right+products+and+partner+up+for+sales+
19AGENDA
• 10:00*+ 10:10*Introduction*(Anders*Tullgren)
• 10:10*– 10:35*Building*a*successful*biosimilar*company*(Manfred*Weiler)
• 10:35*– 11:00*Biosimilars*in*ophthalmology*(Laszlo*Bekesi)
• 11:00+11:15*Xbrane Biopharma*(Martin*Åmark)
• 11:15*– 11:30*QnAWET AMD)AND)DME)ARE MAJOR)DISEASES IMPAIRING PATIENTS VISION
Age$related macular degeneration Diabetic macular edema
• Prevalence)1;3%,)increasing)rapidly)at)+65)years) • Diabetes)affecting)10%)of)population)– working)
age age
• 1;3%)of)diabetic)patients)develop)macular)edema
with)vision)loss
Source:(Klein(et(al.(Ophthalmology(20079(114:(253>262(|(Klein(et(al.(Ophthalmology(19929(99:(933>943(|(Kahn(et(al.(Am(J(Epidemiol 19779(106:(17>32(|(Vingerling et(al.(Ophthalmology(19959(102:(205>210(|(Wang(et(al.(Ophthalmology(20079(114:(92>98(|( 21
Mitchell(et(al.(Ophthalmology(19959(102:(1450>14601.#Itroduction VISION#IMPAIRMENT#LIMITS#PATIENTS#ABILITY#TO#LIVE#NORMAL#LIVES
VEGFA(INHIBITORS(HAVE(REVOLUTIONIZED(TREATMENT
23TREATMENT'WITH'VEGFA'INHIBITORS'TYPICALLY'OVER'MULTIPLE'YEARS
SIGNIFICANT$UNMENT$MEDICAL$NEED$DUE$TO$HIGH$COST$OF$TREATMENTS$
AND$REIMBURSEMENT$RESTRICTIONS
Europe'and'US'(number'of'eyes,'million) Rest'of'world'(number'of'eyes,'million)
5,2
12,9
1,4$
7,1$
3,8$ 1,7
0,7$
5,8$
0,4$
0,6$ 0,5?1,0
0,5$
0,1$ 0,1$
Prevalence Treated Prevalence Treated
wAMD DME Eylea Lucentis Avastin wAMD DME Eylea Lucentis Avastin
Source:(Analysis(based(on(prevalence(of(diseases,(sales(data(from(IQVIA(on(Lucentis and(Eylea assuming(6(doses(per(patient(per(year(and(survey(data(on(usage(of(AvastinCURRENTLY2SUB!OPTIMAL2EFFECT2DUE2TO2EXPENSIVE2TREATMENTS
12 Clinical2trials1
Visual2improvement2after2122months2(letters)
11 Real2world data2EU2
10
9
8
7
6
5
4
3
2
1
0
!1 3 4 5 6 7 8 9 10 11 12
Number2of2Lucentis®2injections2in21st2year
Source:(1)(HARBOR0(ANCHOR0(MARINA0(PrONTO0(VIEW10(VIEW20(CATT0(IVAN(trials0(2)(LUMINOUS(trials. 26LUCENTIS®'AND'EYLEA®'ONLY'APPROVED'VEGFA'INHIBITORS'FOR'OPHTALMIC'
USE'5 AVASTIN®'USED'OFF5LABEL
Lucentis® Eylea® Avastin®
Treatment • Designed to treat macular • Designed to treat macular • Anti-body used to treat different
degenerations degenerations types of cancers (off-label)
Efficacy • 7 – 11 letters 1
(vision'improvement after • 7 – 11 letters 1 • Non-inferiority to Lucentis • Non-inferiority to Lucentis
12'months) demonstrated 2
demonstrated 3
Safety • Generally well tolerated 1 • Similar safety profile as • Various safety issues
Lucentis demonstrated2)
Avarage US EUR 9 600 EUR 9 760 EUR 900
Off5label
cost usage
(Per5patient5
per5year) EU EUR 4 200 EUR 4 453 EUR 1 020
Note:.'Source:'1)'HARBOR,'ANCHOR,'MARINA,'PrONTO trials='2)'VIEW1'and'VIEW2'trials='3)'CATT'trial,'Pharmacies='Assuming'price'discount'of'30K40%'vs.'reference'product=''Based'on'real'world'data'from'
Swedish'Macular'Registry.
Exchange'rate'EUR/SEK=10.4638'as'of'June'30'2018.MARKET&IS&GROWING&AT&11%&PER&YEAR&– LUCENTIS® STILL&DEMONSTRATES&
STRONG&GROWTH&
Market&for&VEGFa inhibitors&for&ophthalmic&use&(EUR&billion)
10
9,1 11,5%
9
7,9
8
7,3
7
6 5,9
5,1
5 4,6
4
3
2
3,2 9%
2,7 2,8
1
0
2016 2017 2018
Note:&EUR/USD&=&1.2003&as&of&December&31&2017.&Source:(1)(Evaluate(Pharma3(2)(Swedish(Macular(Registry. 28EYLEA® AND(LUCENTIS® USED(WITH(SIMILAR(NUMBER(OF(INJECTIONS(PER(
YEAR(DESPITE(LABEL(DIFFERENCE
Average(number(of(injections(per(year((Swedish(macula(register)
15
10
5
0
Note:(Dalton(is(the(unit(for(atomic(mass.(Source:(Company(information.AVASTIN® IS(ATTACHED(WITH(SERIOUS(SAFETY(RISKS
16%$significant$ 0.86$(0.75D0.98)
increased$risk$with$ Death
Avastin
0.83$(0.64D1.08)
Myocardial$infarction
1.03$(0.92D1.16)
Bleeding
28%$significant$ 0.78$(0.64D0.96)
increased$risk$with$ Stroke
Avastin
0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3
More$events$with$Avastin More$events$with$Lucentis
Source:(Curtis(LH,(et(al.(Arch(Ophthalmol 2010;128:1273?9,(Adjusted outcomes at(1(year for the comparison of(ranibizumab (n(=(19,026)((and bevacizumab (n(=(21,815)(as(first?line(therapyFUTURE WET AMD LANDSCAPE+– WHAT IS+IN+THE+PIPELINE?
Wet$AMD(Development(Pipeline(and(Marketed(Assets
Phase(I/II
Phase(II
Phase(III
PAN+90806+: PanOptica ICON:1+: Iconic+Therapeutics Marketed
Brolucizumab : Novartis
SF0166+: SciFluor APL:2+: Apellis
Abicipar (Abicipar pegol)+: Lucentis+(ranibizumab)+:
OPT:302+– Opthea Allergan/Molecular+Partners AG Novartis
GB:102+(sunitinib)+: Greybug Faricimab+– Roche
Vision+
Conbercept+– Chengdu+KH Eylea+(aflibercept)+:
Zimura (avacincaptad pegol)+–
Ophthotech Corporation XLUCANE+ranibizumab Regeneron/Bayer/Sanofi
(Lucentis)+biosimilar+– Xbrane
DE:122+(carotuximab)++– Tracon
Pharmaceuticals/Santen+ ranibizumab+(Lucentis)+biosimilar+ Avastin*+(bevacizumab)+:
: Samsung+Bioepis Co.,+Ltd. Genentech++
ALK+4290++– Alkahest
ranibizumab+(Lucentis)+biosimilar+
ranibizumab++PDS– Genentech+ : Formycon/Bioeq
KH+902+(Conbercept)+: Chengdu+ aflibercept+(Eylea)+biosimilar+–
Kanghong,+ Mylan/Momenta+
Marketed2in2China2only2 Pharmaceuticals
Legend Biosimilar+ *Used+off:label
Route2of2Administration Injection+ Ophthalmic/Drops PO/Tablet Topical+Solution+ Implant
Mechanisms/Targets Chemokine+CCL11+ Molecule+receptor+
VEGF:A VEGF:C/VEGF:D VEGFR:2+inhibitor+ Anti:endoglin+MAb
inhibitors tyrosine+kinase+inhibitor
Complement+factor+C3+ Anti:tissue+factor+MAb+factor+VII+
Complement+factor+C5+inhibitor Integrin alpha 5+beta+3+inhibitor
inhibitor conjugate
31BIOSIMILARS)LIKELY)TO)TAKE)MAJORITY)OF)FUTURE)+€10B)VEGFA)INHIBITOR)
MARKET)IN)EUROPE)AND)US
Market)for)VEGFa inhibitors)for)ophthalmic)use)(€b)
Rest)of world
€)+10)billion
€)9.1)billion
€)8)billion Novel
Biosimilars Europe and)US
+75%)volume/)
60%)value
Price Volume share
2018 2025
Number)of)patients*)(m): 1,1)million +2)million
Doses)per)patient)per)year:) Up)to)6 6\8
Average)price)per)dose: €1100 Novel:)€1100
Biosim:)€500\600
Products)on)market: 2)(Lucentis)and) 3\5)biosimilars
Eylea) 2\6)novel
*Patients)on)approved)products)Lucentis and)Eylea 32
Source:)Xbrane analysis,)Datamonitor.SUMMARY • VEGFa inhibitors.have.revolutionized.treatment.for+several+severe+eye+disorders+(wAMD and+ DME) • Severe.unmet.medical.need.: 18+million+individuals+affected+: 1+million+on+treatment+with+ approved+products • Lucentis®+and+Eylea® only+approved+products+: €5:10.k.per.patient.and.year • Avastin® used.off:label due+to+lower+cost+despite.severe.safety.risks • Pipeline.of.novel.drugs.is.drying.out • Biosimilars.expected.to.take.majority.of.future.+€10.billion.VEGFa inhibitor.market.in. Europe.and.US
AGENDA
• 10:00*+ 10:10*Introduction*(Anders*Tullgren)
• 10:10*– 10:35*Building*a*successful*biosimilar*company*(Manfred*Weiler)
• 10:35*– 11:00*Biosimilars*in*ophthalmology*(Laszlo*Bekesi)
• 11:00+11:15*Xbrane Biopharma*(Martin*Åmark)
• 11:15*– 11:30*QnALead%candidate%in%phase%III%and%5%pre0clinical%assets
Xlucane (targeting Lucentis®) 5 pre-clinical assets
• Late stage clinical candidate • 1 asset with signed partnership, (MAA anticipated 2020)
• Study design acceptance from FDA (2019-01-15) • 4 pre-clinical assets in pipeline targeting drugs with total annual
sales of SEK 6bn
• Currently the only Lucentis® biosimilar with a signed
commercialization partner • Multiple candidates enables continuous news flow
• Sales potential exceeding SEK 3bn per year • High quality technology platform enabling development of new
candidates
Commercialization
Candidate Indication Novel drug target Phase I Phase II Phase III Partner
Rights
Xlucane Macular Degeneration 2019-2021
• Wet AMD 1 Lucentis® Not Applicable (initiated) Wholly-
(Roche & Novartis) owned
• DME 2 Success rate
Phase III
97%
Rheumatoid and Psoriatic Cimzia®
Xcimzane Not Applicable 2022-2024
arthritis Chrons desease (UCB)
To be decided
Xoncane Acute lymphoblastic leukemia Oncaspar® Wholly-
Not Applicable 2022-2024 owned
Spherotide Advanced metastatic prostate Decapeptyl®/Triptorelin
(Hybrid) cancer, breast cancer, endometriosis Debiopharm/Ipsen/Ferring Not Applicable 2019-2020 o
1.#Wet#Age)Related#Macular#Degeneration#(wAMD)
Success rate
MAA/BLA
2.#Diabetic#Macular#Edema (DME) Completed development Planned clinical trails 97-98%Biosimilar'pioneer'STADA'(~EUR'5bn'market'cap)'to'sell'and'market'Xlucane o
Summary'of'the'co.development'partnership'with'STADA Experienced'in'successfully'launching'biosimilars
2018 • STADA is a German pharma company, specialising in the production and sales of
Equal share of profit at EBIT level
50/50 Equal share of development expenses generic and OTC drugs. It has ~11,000 employees globally, production sites in 7
profit/expense sharing
Partnership'announced (worth EUR 20m) countries2) and sells its products in more than 130 countries
• Marketing and sales are STADA’s strengths, in-licensing and co-developing drugs
2019 EUR 7.5m
Upfront payment of EUR 7.5m to Xbrane
with partner companies
upfront payment
• Xbrane-partnership in-line with group strategy, developing their biosimilar
portfolio and complementing the diabetes segment
Phase lll Xbrane responsible until completion of
2020 clinical study authorization applications to EMA and FDA • Market cap of EUR ~5bn, being listed on the Frankfurt stock exchange
STADA in the biosimilar field:
MAA/BLA approval
Submission anticipated mid 2020
2021 process
• STADA introduced its first biosimilar for the therapeutic areas of nephrology and
oncology as early as 2008. In 2014 another biosimilar product was introduced for
the indication of chemotherapy-induced neutropenia
Sales and marketing STADA responsible for sales and marketing
2022
• Previous biosimilar partnership experience with Gedeon Richter which includes a
biosimilar for the area of oncology used for non-Hodgkin lymphoma
• STADA’s vision includes a closer and more comprehensive focus on the biosimilar
market
The'partnership'has'significantly'de.risked'the'development'risk'and'increased'sales'potential.'
Note:'1)'Partnership'covers'NA,'APAC,'MENA'and'Europe'(not'MECE).'2)'As'of'2014.'Source:(Company(website4(Annual(reports4(Factset.Sales*potential*of*EUR*3006350m*(ONLY*IN*EU*AND*US)
Potential of reaching
currently untreated patients
Potential of gaining market in emerging markets with
share from off-label usage of lower priced product
Avastin providing a safer
treatment option at
reasonable cost
1400,0 Potential of 50% increased
number of doses per patient
1200,0 Capturing 25% of expected per year in EU/US due to
Lucentis biosimilar market in lower costs
1000,0
EU/US at 30-40% price
800,0 reduction
600,0 EUR$150'175m2)
400,0 EUR$300'350m1)
200,0
0,0
Base$case Total
Xlucane base*case*peak*sales*potential*of*EUR*3006350m*with*significant*further*upside
Gross*margins*expected*at*+90%,*profits*shared*50/50*with*STADAPhase&III&study&design&acceptance&– enabling&marketing&authorization&across&key&
markets&globally&before&launch
Recruitment,9,months Treatment,12,months
Start
o
• Multi-regional clinical trial with 150 sites
across EU, US, India, China and Russia Xlucane
290 patients
• Enable Marketing Authorization across
key markets globally
• Partnership with highly qualified global
CRO Lucentis®
290 patients
• FDA Clinical trial approval, other countries
pending
Primary end-point Secondary end-points
Change in Visual acuity after 12 months e.g.
(“BCVA”) after 8 weeks Immunogenicity, BCVA,
Retina thicknessPublic'peers and'candidate development
Overview'of'conducted'clinical'trials Key take-away
Commercialisation Other biosimilars Market Cap.
Candidate (target) Developer Partner under development (SEK in million) Other Partners Few Competitors
Momenta Copaxone (approved)
Eylea Phase III Pharmaceuticals, None Levonix (approved) SEK 9 400 Mylan
Inc. Humira (Phase III)
Eylea
Neulasta (approved in
Pre-Clinical
Coherus Bio
None
US)
SEK 7 500 Xlucane is 1 of 3
Sciences, Inc. Humira (Phase III)
Enbrel (Phase III) Lucentis biosimilars in
Lucentis
clinical stage (4 in total),
and the only one with
a commercialization
Lucentis Phase III Formycon AG None 2 pre-clinical SEK 2 500 Bioeq IP
partner.
Teraparatide (Phase III)
Lucentis Phase I Pfenex Inc. Pfizer (Aborted)
4 pre-clinical
SEK 1 140
CR Pharma
Xbrane
Lucentis Phase III
Biopharma AB
STADA
! 4 pre-clinical SEK 290 (Distribution in !
China)
Note:&Data&provided&by&S&P&CapitalIQ 2019;01;14Important)milestones)reached)in)2018
Signed partnership with CR Pharma (China)
Anders Tullgren joined the board as Chariman
Signed commercialization deal with STADA
STADA paid EUR 7.5m in up-front payment
Strategic decision to focus on Biosimilars
Positive feedback from the FDA phase III Xplore
meeting
Xbrane has)during)2018))delivered)according)to)scheduled)milestonesSignificant value drivers*ahead
Development*timeline
Other
Xlucane
Candidates
Phase III
CTA submission MAA/BLA
100% Recruited
Submission
Phase III Phase III/Xplore
Approval
CTA approval 25/50/75% Recruited
Phase III/Xplore
Interim Phase III/Xplore
First Patient Clinical Data
Recruited
Phase III/Xplore Sales launch
Marketing
(patent loss)
H1 2019 H2 2020 2021 2022 2023
Spherotide Partnership deal XM1 & XM2
with pre-clinical Partnership deal
Partnership deal assets
Spherotide
Phase III initiation with MAA/BLA
Spherotide SubmissionSummary
Late2stage2candidate2 Xlucane,+XBrane’s lead candidate,+a+Lucentis®+biosimilar,+has+received+FDA+acceptance of+
entering2phase2III initiation+for+Phase2III2clinical2trials.2Clinical+design+available+at+Clinicaltrails.gov*
Historical2low2risk
Biosimilars+have+higher probability of+success (95%)+from+initiation+of+phase+III+contrary+to+
de@risking2the2case
novel+biological+drugs+(50%)
EUR2300m2sales2 Market+roll+out+for+Xlucane 2022+in+collaboration+with+STADA,2with+estimated+peak+sales+of+
potential2estimate2by2 EUR+300+– 350m+in+base+case
STADA
Pipeline2assures2
continued2news2flow2 Xbrane will+during+2022+have+multiple other+candidates in+clinical+Phase+III+trials
Xbrane is+well+positioned+for+a+rapid+market+rollQout+having+a+deQrisked+biosimilar+candidate
42
*Comparing+the+Efficacy+and+Safety+of+Biosimilar+Candidate+Xlucane Versus+Lucentis®+in+Patients+With+nAMD (XPLORE),+Xbrane Biopharma+AB+and+STADA+Arzneimittel AG
(https://)clinicaltrials.gov/ct2/show/NCT03805100?term=xlucane&rank=1AGENDA
• 10:00*+ 10:10*Introduction*(Anders*Tullgren)
• 10:10*– 10:35*Building*a*successful*biosimilar*company*(Manfred*Weiler)
• 10:35*– 11:00*Biosimilars*in*ophthalmology*(Laszlo*Bekesi)
• 11:00+11:15*Xbrane Biopharma*(Martin*Åmark)
• 11:15*– 11:30*QnAYou can also read
