BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase...

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One For All BiondVax Pharmaceuticals Ltd. Universal Flu Vaccine One For All One For All BiondVax – TASE, May 2012

Transcript of BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase...

Page 1: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

One ● For All

BiondVax Pharmaceuticals Ltd.

Universal Flu VaccineOne ●For AllOne ●For All

BiondVax – TASE, May 2012

Page 2: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

Forward Looking StatementsOne ● For All

AgendaIntroduction

Forward Looking Statements

This presentation includes “forward‐looking statements” within the meaning ofli bl iti l Th f d l ki t t t i l i k dIntroduction

ScienceClinical TrialsMarketValue Proposition

applicable securities laws. These forward‐looking statements involve risks anduncertainties, including those identified within the “Risk Factors” section of theCompany's Shelf Prospectus dated January 17, 2012.

pRoad Ahead

Although management of the Company believes the expectations reflected insuch forward‐looking statements are based on reasonable assumptions, theCompany cannot assure investors that these expectations will prove correct, andCo pa y ca ot assu e esto s t at t ese e pectat o s p o e co ect, a dthe actual results that the Company achieves may differ materially from anyforward‐looking statements, due to such risks and uncertainties.

BiondVax – TASE, May 2012 2

Page 3: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

One ● For All

AgendaIntroduction►IntroductionScienceClinical TrialsMarketValue Proposition

pRoad Ahead

Introduction

BiondVax – TASE, May 2012

Page 4: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

Flu: the Most Common Infectious DiseaseOne ● For All

AgendaIntroduction

5‐15% of world population get the flu each year►Introduction

ScienceClinical TrialsMarketValue Proposition

• The challenge of seasonal flu1:– 600 million to 1 billion cases of influenza globally– 3 to 5 million cases of severe illness

pRoad Ahead

3 to 5 million cases of severe illness– 300,000 to 500,000 deaths– Huge economic burden: $90 billion in US2

• Flu in elderly:– 1 in 4 people in OECD countries predicted to be elderly (65+) 

i 20 03in 20503

– About 70% of elderly in US receive flu vaccines4

– Only a small % respond sufficiently5

– Elderly account for 90% of flu–related deaths in US2

1 WHO, Acute Respiratory Infections (Update September 2009)2 Poland and Mulligan JID 2009:200

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Poland and Mulligan. JID 2009:2003 OECD Factbook 2009 Economic, Environmental and Social Statistics 4 http://stats.oecd.org/Index.aspx?DataSetCode=HEALTH PROC5 Minimum seroconversion required for vaccine approval for elderly is 30% 

Page 5: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

BiondVax’s Road MapOne ● For All

AgendaIntroduction

p

BiondVax today►Introduction

ScienceClinical TrialsMarketValue Proposition

today

Prof. Ruth Arnon & Dr. Tamar Ben‐Yedidia

pRoad Ahead

Basic research W i

BiondVax Pharmaceuticals LtdWeizmann Institute Human Clinical Trials

Weizmann Institute

BiondVax Pharmaceuticals Ltd.

Established in 2003 Exclusive, worldwide license 

agreement with the 

Weizmann Institute

More than 15 years of R&D led by Prof. Arnon and her team

Human Clinical Trials

Positive safety & immunogenicity

FDA Pre‐IND (July 2008) Two Phase I/II clinical trials:g

Weizmann Institute Publicly‐traded on Tel Aviv 

Stock Exchange since June 2007 (TASE:BNDX) 

$

Established feasibility in animals prior to founding of BiondVax 

Registration of initial patents 

63 younger adults (18‐49) 60 older adults  (55‐75) Two Phase II  clinical trials: 200 younger adults (18‐49) 120 elderly (65+)

BiondVax – TASE, May 2012 5

Raised ~$18m since its inception

on universal influenza vaccine 120 elderly (65+) Next Phase II  in EU, 150 

elderly (65+) 2012‐13

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One Recombinant Protein – Two ProductsOne ● For All

AgendaIntroduction►IntroductionScienceClinical TrialsMarketValue Proposition

Multimeric‐001 (M‐001)►

pRoad Ahead

Universal Flu Vaccine Combination Flu Vaccine

ONE VACCINE  F l & d i fl

ENHANCER of TIV1

P i M 001 & B t TIV

Every 3‐5 years Yearly prior to TIV

For seasonal & pandemic flu strains

Multi‐year protection

Prime: M‐001 & Boost: TIV Elderly and other at‐risk populations (seasonal)

Pre‐pandemic primer

Requires new surrogate marker Existing HAI surrogate marker

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1TIV (trivalent influenza vaccine) is standard, injectable commercially available strain‐specific flu vaccine

Page 7: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

One ● For All

AgendaIntroductionIntroductionScienceClinical TrialsMarketValue Proposition

pRoad Ahead

Science

BiondVax – TASE, May 2012

Page 8: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

The Multimeric‐001 VaccineOne ● For All

AgendaIntroduction

M‐001 Concept: Common DenominatorThe Multimeric‐001 (M‐001) is comprised of a 

i d i t bi ti f i

The Multimeric‐001 VaccineA single recombinant 50 kDa polypeptide 

t i i h f th i li it iIntroductionScienceClinical TrialsMarketValue Proposition

unique and proprietary combination of nine selected linear B‐ and T‐cell epitopes that are conserved and common to most influenza strains

containing each of the nine linear epitopes in triplicate produced year‐round in E.coli at BiondVax cGMP facility.

The Influenza Virus

pRoad Ahead

Hemagglutinin (HA) x 5(B & T C ll)

The Influenza Virus

(B‐ & T‐Cell)

NucleoProtein x 3(T‐Cell)

M1 Matrix Protein x 1(T‐Cell)

S l t d it

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Selected epitopes from HA, NP and M 

proteins

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Clear Regulatory PathwayOne ● For All

AgendaIntroduction

g y y

• FDA Pre‐IND meeting in 2008IntroductionScienceClinical TrialsMarketValue Proposition

• Israeli MOH IRB & IND submissions and clinical trials 2009 – present

• Meeting with European regulators at Paul Ehrlich Institute in June 2010:– Prime‐boost regimen to be developed initially for the elderly and other high‐risk

pRoad Ahead

Prime‐boost regimen to be developed initially for the elderly and other high‐risk groups (e.g. chronic patients)

– Proposed label: 

“For the enhancement of the active immunization offered by subsequent f ff y qadministration of a standard seasonal or pandemic influenza vaccine, against influenza disease caused by influenza virus”

• Meetings at NIH in April 2012:– Priming in elderly for TIV (seasonal) 

– Priming in young adults for  H5N1 avian flu vaccine (pandemic)

• Request for second pre‐IND meeting with FDA regarding universal priming indication; submitted April 2012

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Page 10: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

One ● For All

AgendaIntroductionIntroductionScienceClinical TrialsMarketValue Proposition

pRoad Ahead

Clinical Trials

BiondVax – TASE, May 2012

Page 11: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

4 Successful Clinical Trials – 440 participantsOne ● For All

AgendaIntroduction

p pBVX‐002, ‐004 : Younger Adults BVX‐003, ‐005 : Older Adults/Elderly

Phase I/II (BVX‐002): 63 participants ♀ ♂ Phase I/II (BVX‐003): 60 participants, ♀ ♂,IntroductionScienceClinical TrialsMarketValue Proposition

Phase I/II  (BVX 002): 63 participants, ♀ ♂, 18‐49 years old. June – December 2009. Randomized, single‐blind, placebo‐controlled escalating double‐dose.

Phase II (BVX‐004): 200 participants ♀ ♂

Phase I/II (BVX 003): 60 participants, ♀ ♂, 55‐75 years old. Sept 2009 – April 2010. Randomized, single‐blind, placebo‐controlled escalating double‐dose, prime‐boost full TIV dose.

pRoad Ahead

Phase II (BVX 004):  200 participants, ♀ ♂, 18‐49 years old. Oct 2010 – June 2011. randomized, two stage, double‐blind, placebo‐controlled two‐dose, combined vaccination, partial TIV dose (15% or 50%).

Phase II (BVX‐005):  120 participants, ♀ ♂, 65‐91 years old. Aug 2011 – Feb 2012. Multicenter, randomized, double‐blind, placebo‐controlled , prime‐boost full TIV dose.

Younger Adults Older Adults / ElderlyClinical Trial BVX‐002 BVX‐004 BVX‐003 BVX‐005Endpoints:

Safety

Immunogenicity

Humoral M‐001 TBD

Primary endpoint:Safety

Secondary (exploratory)endpoint: Humoral

(antibodies) HAI N/A (partial TIV) (full TIV) (full TIV)

Cellular

IFN‐g

IL 2 N/D N/D

endpoint: Immunogenicity

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Cellular IL‐2 N/D N/D

FACS N/D N/D

Page 12: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

M‐001: Good Safety Profile & Well‐ToleratedOne ● For All

AgendaIntroduction

No significant differences between treatment and control groups

y

IntroductionScienceClinical TrialsMarketValue Proposition

Trial  Year Population (age) N (M‐001) N (Placebo) Total N

BVX‐002 2009 Younger Adults (18‐49) 3 + 40 20 63

pRoad Ahead BVX‐003 2010 Older Adults (55‐75) 40 20 60

BVX‐004 2011 Younger Adults (18‐49) 112 88 200

BVX‐005 2012 Elderly (65+) 90 30 120

285 158 443

No treatment related Severe Adverse Events

285 158 443

No treatment‐related Severe Adverse Events

Most adverse events were mild

All adverse events observed were transient All adverse events observed were transient

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Page 13: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

Design of Latest Phase II in Elderly (BVX‐005)One ● For All

AgendaIntroduction

g y ( )Prime‐Boost in Elderly

• 120 participants, ♀♂, 65+ years old (mean age: 72.2±5.5, range: 65‐91Y)IntroductionScienceClinical TrialsMarketValue Proposition

120 participants, ♀♂, 65+ years old (mean age: 72.2±5.5, range: 65 91Y)• Multicenter, randomized, placebo‐controlled and double‐blind• Aug 2011‐Feb 2012• Identity between 2010/11 and 2009/10 TIV strains

pRoad Ahead

Group  DAY 0 DAY 21 DAY 42 N

y / /• Participants screened for seronegativity to at least two TIV strains

Legend

A M‐001 (500μg) M‐001 (500μg) TIV 30

B M‐001 (500μg) TIV  30

C Alum Adj M‐001 (500μg) TIV  ‐ 30Legend

Adj M‐001 Adjuvanted Multimeric Vaccine (Alum)

PBS Phosphate‐

D PBS TIV  ‐ 30

TOTAL 120

Study endpoints:buffered saline (placebo)

TIV Trivalent Inactivated Vaccine

1. Safety2. Immunogenicity

• HAI• FACS analysis for CD4+/CD8+ cells secreting IFN gamma

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Vaxigrip 2010/11

y g g• Ab to M‐001

Page 14: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

M‐001 Improves Immunity to All Tested TIV StrainsOne ● For All

AgendaIntroduction TIV T i M 001 TIV

StrainsMore People Seroconverted1 to TIV viruses (HAI)

BVX‐003IntroductionScienceClinical TrialsMarketValue Proposition 50

60

70

80

ersio

n

TIV Twice M‐001 + TIVBVX 003

Priming with M‐001 results in increased 

pRoad Ahead

20

30

40

50

% se

roconve

HAI seroconversion for ALL tested TIV 

strains

0

10

A/Brisbane/59/07 A/Brisbane/10/07 B/Brisbane/60/08

70 TIVMinimum required for regulatory approval BVX‐005

40

50

60

70

version

TIVM‐001 + TIVTwice M‐001 + TIV

*

1. Seroconversion: % of individuals with mean fold increase in HAI ≥4x  and HAI 

regulatory approval

10

20

30

40% Serocon≥ 1:40 post‐immunization 

2. In BVX‐003: 500 mcg M‐001, TIV (Vaxigrip 2009) and Placebo (either PBS or adjuvanted PBS)

3. In BVX‐005: 500 mcg M‐001, TIV 

BiondVax – TASE, May 2012 14

0

A/California/7/09 A/Perth/16/09 B/Brisbane/60/08

(Vaxigrip 2011) and Placebo (PBS).        * = P<0.05

Page 15: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

Superiority Criteria: Fluzone HD Case StudyOne ● For All

AgendaIntroduction

p y yFluzone HD (Sanofi Pasteur) licensed in 2009 in USA for elderly 

IntroductionScienceClinical TrialsMarketValue Proposition

• Contains 4 times more HA than standard TIVs (60 mcg of each strain)• Phase III trial: 2541 participants receiving HD, 1240 participants receiving SD• Overall superiority = superiority for each measure for at least 2 strains without 

pRoad Ahead inferiority for any strain” 

Superiority (Falsey et al. JID (2009) 200)> 1.5*Ratio of GMTs (Fluzone HD/Fluzone)

> 10%*Difference in SCR (Fluzone HD ‐ Fluzone)* Lower Bound of 2-sided 95% Confidence Interval (CI)

Non Inferiority (FDA)≤ 1 5Ratio of GMTs (US licensed vaccine / New vaccine)

( )

≤ 1.5 Ratio of GMTs (US licensed vaccine / New vaccine)

≤ 10%Difference in SCR (US licensed vaccine ‐ New vaccine)

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M‐001: A Universal Primer for TIVOne ● For All

AgendaIntroduction

>10% Elevation in Seroconversion

IntroductionScienceClinical TrialsMarketValue Proposition

BVX‐003Non‐Adjuvanted M‐001 500mcgPrime twiceTIV: Vaxigrip 2009/10 Sanofi

Mean of 95% confidence interval

Ratio of GMT increaseGroups given (M‐001 followed by 

TIV) divided by (TIV alone)

Difference in seroconversion rates (%)

Groups given (M‐001 followed by TIV) minus (TIV alone)

►p

Road AheadTIV) minus (TIV alone)

A/Brisbane/10/07 H3N2 0.9 non‐inferior 25% SUPERIORA/Brisbane/59/07 H1N1 1.3 non‐inferior 35% SUPERIORB/Brisbane/60/08  1.0 non‐inferior 25% SUPERIOR

BVX‐005Non‐Adjuvanted M‐001 500mcgPrime onceTIV: Vaxigrip 2011/12 Sanofi

Mean of 95% confidence interval

Ratio of GMT increaseGroups given (M‐001 followed by  

TIV) divided by (TIV alone)

Difference in seroconversion rates (%)

Groups given (M‐001 followed by TIV) i (TIV l )g p / ) y ( ) TIV) minus (TIV alone)

A/Perth/16/09 H3N2 1.3 non‐inferior 13% SUPERIORA/California/7/09 H1N1 1.7 SUPERIOR 20% SUPERIORB/Brisbane/60/08 1.0 non‐inferior 7% non‐inferior

Considerations:• Small trial size• Relatively early day of immune evaluation (21 days post TIV immunization)• Identity between 2011/12 and 2009/10 TIV strains (BVX‐005)

BiondVax – TASE, May 2012 16

Identity between 2011/12 and 2009/10 TIV strains (BVX 005)• Screening of subjects for seronegativity to at least two TIV strains 

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2nd Phase II (BVX‐005) Summary: SuccessOne ● For All

AgendaIntroduction

( ) y

BiondVax’s M‐001 vaccine has a good safety profile and is well‐IntroductionScienceClinical TrialsMarketValue Proposition

BiondVax s M‐001 vaccine has a good safety profile and is well‐tolerated

M‐001 vaccine enhanced the elderly (65+) participants’ responses to 

pRoad Ahead

y ( ) p p pseasonal flu vaccine (TIV) confirming previous results in older adults 

This improved immunity to influenza in the elderly was generated by single priming with M‐001 vaccine without any added adjuvant

M‐001 vaccine alone induced cellular responses to several influenza strains including H1N1 and H3N2 strains providing the rationale for astrains including H1N1 and H3N2 strains, providing the rationale for a mechanism of action that supports both indications: the current combination vaccine as well as its future potential to serve as a universal vaccineuniversal vaccine

BiondVax – TASE, May 2012 17

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One ● For All

AgendaIntroductionIntroductionScienceClinical TrialsMarketValue Proposition

►p

Road Ahead

Market

BiondVax – TASE, May 2012

Page 19: BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase II (BVX‐005): 120 participants, ♀♂, 65‐91 years old. Aug 2011 –Feb 2012.

Flu Vaccines: Large & Growing MarketOne ● For All

AgendaIntroduction

g g

Seasonal Flu Vaccine Market Flu Vaccine MarketIntroductionScienceClinical TrialsMarketValue Proposition $1,077m

Others$446m

• Seasonal Flu: 2010 sales: ~$3bn worldwide2

~500m doses supplied2►

pRoad Ahead

38%3%

16%$91m

Forecasted CAGR of 6‐10% over next 5 years

Expected 2016 sales: ~$5 bn38%

7%

4%

$200m

$104m• Pandemic Flu:Swine Flu (A/H1N1), 2009  sales: ~ $3.6 bn worldwide3 (in addition to seasonal 

14%18%

$flu vaccine sales)

$378m1

$516m2http://www.sanofipasteur.com/sanofi‐pasteur2/sp‐media/SP_CORP/EN/222/1758/EN_Factsheet%20SP%20world%20manufacturer_2011.pdf3http://www.gsk.com/investors/presentations/2011/2011‐03‐23‐

ti d iti df

BiondVax – TASE, May 2012 19

Source: Datamonitor, BCC Research1BiondVax estimate. Actual Novartis 2008 Influenza Vaccine sales data are not publicly available

martin‐andrews‐citi.pdf

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M&A Activity – Vaccine MakersOne ● For All

AgendaIntroduction

ySignificant Vaccine Transactions

($m, log‐scale)IntroductionScienceClinical TrialsMarketValue Proposition $5.4bn

$15.6bn

$68bn

$6.6bn10,000

100,000

►p

Road Ahead $1.5bn$888m

$1,5bn

$480m $380m $364m$550m $781m

$2.4bn

1,000

10

100

12002 2003 2005 2006 2007 2008 2009 2010

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M&A Activity: Phase II Biotech BenchmarksOne ● For All

AgendaIntroduction

M&A Activity: Phase II Biotech Benchmarks

IntroductionScienceClinical TrialsMarketValue Proposition

CompanyCerexa1 Novexel2 BiPar3 Facet 

Biotech4 BioVex5Description

Anti‐ Anti‐ Multiple►

pRoad Ahead Activity Anti‐

bacterialAnti‐bacterial Anti‐cancer Multiple 

Sclerosis Anti‐cancer

Buyer Forrest Lab AstraZeneca Sanofi‐

Aventis Abbott AmgenLab Aventis

M&A($millions)

$480 cash$100 MS

$430 cash$75 MS

$500 cash + MS $450 cash $425 cash

$475 MS

MS - milestone

1 (2006) http://www.domainvc.com/PDF/Cerexa%20Forest%201.05.pdf2 (2009) http://www.antiinfectivesconsulting.com/PDF/Novexel_Press_Release.pdf3 (2009) http://www.fiercebiotech.com/story/hungry‐sanofi‐snaps‐bipar‐500m‐deal/2009‐04‐154 (2010) http://www.nature.com/nbt/journal/v28/n5/full/nbt0510‐387.html5 (2011) h // l h k/fi / b / h i l d h i l /8280114/A b

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5 (2011) http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/8280114/Amgen‐to‐buy‐experimental‐cancer‐drug‐maker‐Biovex‐in‐1bn‐deal.html

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BiondVax Leads the WayOne ● For All

AgendaIntroduction

y

Company Product Technology Phase Last News

Universal Flu Vaccines in DevelopmentIntroductionScienceClinical TrialsMarketValue Proposition

Company Product Technology Phase Last News DatePre-clinical Phase I Phase II

BiondVax Multimeric-001 Multi-epitope (B&T)recombinant protein Feb-2012►

pRoad Ahead Dynavax N8295 NP-M2e fusion protein

plusTLR9ag DNA seq Feb-2011

Vaxinnate M2e-Flagellin M2e-flagellin fusion protein Apr-2009

Colby Cationic lipid withColby(Juvaris) JVRS-100 M2e Cationic lipid with

Tetrameric M2e peptides May-2009

Bionor Vacc-flu NP and M2e domains plusGM-CSF (ID) 2011

Sanofi Pasteur ACAM-FLU-A M2e protein Dec-2009(Acambis) ACAM FLU A M2e protein Dec 2009

Immune Targeting Sys. FP-01 Fluoro-conj. peptides (PA,

PB1, PB2, NP, M1) T-cell 2011

Seek Flu-v 6 T-cell epitopes 28 people challenge Sep-2011g

Crucell / J&J flu-mAb MAbs Jan 2010

PeptiVir PVI-1000 Conformational HA stempeptides 2011

BiondVax – TASE, May 2012 22

Inovio INO-3510 HA DNA constructs (ID) Sep-2010

Sources:  Respective company web sites and press releases.

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Competitive Advantages of Multimeric‐001One ● For All

AgendaIntroduction

p g

BiondVax’s M‐001 universal flu vaccine is the most advanced inIntroductionScienceClinical TrialsMarketValue Proposition

BiondVax s M‐001 universal flu vaccine is the most advanced in clinical development

In all 4 clinical trials BiondVax’s M‐001 vaccine has demonstrated a ►

pRoad Ahead good safety profile and was well‐tolerated

M‐001 vaccine induces cellular and humoral immune responses without any added adjuvant

M‐001 vaccine has two indications: (1) universal flu vaccine, (2) universal primer for seasonal and pandemic flu vaccinesuniversal primer for seasonal and pandemic flu vaccines

BiondVax is the first to develop the priming in elderly model using existing surrogate marker for flu protection (HAI) currently acceptedexisting surrogate marker for flu protection (HAI) currently accepted by FDA and EMA

BiondVax – TASE, May 2012 23

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One ● For All

AgendaIntroductionIntroductionScienceClinical TrialsMarketValue Proposition► pRoad Ahead

Value Proposition►

BiondVax – TASE, May 2012

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Value Proposition: Combination VaccineOne ● For All

AgendaIntroduction

pMedicare Part B Payment Allowances Given yearly with TIV

OECD Peak Sales Potential: IntroductionScienceClinical TrialsMarketValue Proposition os

e ($)

$630 ‐ $3,800m

Peak Sales ($ )

Uptake in Elderly► p

Road AheadPrice pe

r Do ($ m) 35% 70%

5.00 $630 $1,300

10.00 $1,300 $2,500e pe

r se ($

)

Assumptions for Peak Sales:

P 10.00 $1,300  $2,500

15.00 $1,900  $3,800 Pric

Do s

Assumptions for Peak Sales:• Uptake is proportion of elderly that receive M‐

001 as well as TIV• Of note, today  in US TIV uptake in elderly is 70% • Assuming elderly population in OECD in 2050 is

Note: The Medicare Part B payment allowance limits for seasonal influenza and pneumococcal vaccines are 95% of the  • Assuming elderly population in OECD in 2050 is 

~360 million (OECD Factbooks 2009 and 2011)Source: US Dept of Health and Human Services, CMS (Centers for  Medicare and Medicaid Services) accessed at https://www.cms.gov/mcrpartbdrugavgsalesprice/10_vaccinespricing.asp 

pAverage Wholesale Price (AWP)

BiondVax – TASE, May 2012 25

Assuming pricing of Combination Vaccine similar to Fluzone HD and a TIV price of $12, the Multimeric‐001 component could be priced up to $18

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Value Proposition: Pandemic PreparednessOne ● For All

AgendaIntroduction

p p

WHO Global Influenza Preparedness Plan

IntroductionScienceClinical TrialsMarketValue Proposition► pRoad Ahead

BiondVax M‐001 Priming Period Pandemic VaccineM‐001 ReleaseRelease from 

Stockpile

Potential Pre‐Pandemic Sales

OECD Sales ($m)OECD Population Penetration Rate

Assumptions:

OECD Sales ($m)

25% 75%

5.00 $1,500 $4,500 pe

r ($)

BiondVax – TASE, May 2012 26

Assumptions:• Current population in OECD is 1.2bn (OECD 

Factbook 2011)

10.00 $3,000 $9,000 

15.00 $4,500 $13,500 Price 

Dose 

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BiondVax’s Intellectual PropertyOne ● For All

AgendaIntroduction

Solid, Comprehensive IP Protection

p y

IntroductionScienceClinical TrialsMarketValue Proposition

Subject Matter Priority & Assignee Status Expiry1– US 

& EUROPE

P tid B d V i30/11/1998Y d R&D

Granted:  USA, Israel, Australia, Korea, M i N Z l d E ( ll d)► p

Road AheadPeptide‐Based Vaccine for Influenza

Yeda R&D licensed to BiondVax

Mexico, New Zealand, Europe (allowed)Under Examination: CanadaFiled: Hong Kong

Nov 2019

Improved Peptide Based6/12/2005Yeda R&D Granted: USA, Europe 

Improved Peptide‐Based Influenza Vaccine 

Yeda R&D licensed to BiondVax 

Under Examination: Israel, AustraliaFiled: Canada

Dec 2026

Multimeric Multi‐ / /

Filed: Brazil, Canada, Hong Kong, India, Japan, Korea, USAMultimeric Multi

Epitope Polypeptide Influenza Vaccines

2/8/2007BiondVax

Japan, Korea, USAUnder Examination: Europe, Eurasia, Mexico, Israel, ChinaGranted: Australia

Aug 2028

Multimeric Multi‐Epitope Polypeptides as Primer to Improve Seasonal and Pandemic Influenza Vaccines

BiondVax Filed: PCT Unpublished

BiondVax – TASE, May 2012 27

1. NOTE: The expiry dates shown do not reflect any potential extensions that may be granted in the respective jurisdictions (potentially up to a maximum of 5 additional years in the US or 5½ years in some EU countries)

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One ● For All

AgendaIntroductionIntroductionScienceClinical TrialsMarketValue PropositionpRoad Ahead

The Road Ahead►

BiondVax – TASE, May 2012

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Combination Vaccine Regulatory PathwayOne ● For All

AgendaIntroduction

Combination Vaccine Regulatory Pathway

IntroductionScienceClinical TrialsMarketValue PropositionpRoad Ahead

Fourth Phase II1

Third       Phase II

Pivotal    Phase III2

Regulatory Submissions

Phase II

•2‐300  elderly (65+)

•Worldwide

• 150 elderly (65+)

• EU: multicenter

Phase III

• 3,000 – 4,000 elderly (65+)

• Worldwide

Submissions

• US BLA

• EU MAA

•$ 2.5m• $1m • $20 – 25m

1Additi l Ph II ill lik l b f d i i M 001 i i b f H5N1

BiondVax – TASE, May 2012 29

1Additional Phase IIs will likely be performed e.g., examining M‐001 priming before H5N1 avian flu vaccine2Pivotal Phase III clinical trials likely require strategic partner

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One ● For All

AgendaIntroduction One ●For AllIntroductionScienceClinical TrialsMarketValue Proposition

One ●For All

A G Ch fp

Road Ahead A Game Changer for Flu Vaccines

Thank You!

For further details:

Dr. Ron Babecoff, DVMPresident & CEOBiondVax Pharmaceuticals Ltd.T 972 8 9302529

Tanya Gottlieb, PhDBusiness DevelopmentBiondVax Pharmaceuticals Ltd.T 972 8 9302529

BiondVax – TASE, May 2012 30

T: +972‐8‐9302529E: [email protected]

T: +972‐8‐9302529E: [email protected]