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page 1
OUR GOAL IS TO DEVELOP SELF - ADMINISTERED PARENTERAL
MEDICINES BASED ON OUR TRUE IM, SC & ID NEEDLE-FREE AUTO-
INJECTORS THAT OPTIMIZE CLINICAL BENEFITS , PATIENTS
COMPLIANCE WITH ENHANCED COST EFFECTIVE HEALTH OUTCOMES
page 2
SUMMARY
 THE DEVICE
 Full prescribed dose delivered in <1/10s 3
 CROSSJECT OFFER
 Biologics & Super-Generics 11
 APPENDICES 20
ZENEO® & Anaphylactic Shock 27
ZENEO® & Migraine 31
ZENEO® & Arthritis 35
Future development for ZENEO 40
Market segments for ZENEO 43
 CONTACT 50
 PRESS RELEASE ON LAST PARTNERING DEAL 51
1. The device – ZENEO®
Superior patented devices for
the needle-free injection of drugs
Easy – Fast & Safe
page 4
“Poor adherence to long-term treatment of chronic diseases is a worldwide
problem” (according to WHO):
 Adherence in developed countries averages 50%
 Better adherence can produce better health outcomes and limit health
care expenditures
Reducing hospital admissions and caring for people more appropriately
outside of hospital is key.
 Outpatient pharmacotherapy of chronic diseases relies on drug self
administration at home
 Needs Increase with Ageing Population
Self Administration : An Inevitable Evolution
page 5
Zeneo® advantage: ease & safety of use
Ease of use facilitates self-injection,
particularly for populations requiring chronic
treatment.
No needle-phobia; no needle-stick risk
 Increased compliance
 Safety
 Reliability
Decreased « Social stigma »
of the injectable chronic treatments, allowing a
broader acceptance.
Self-Injection by “place and push” in <0.1
second : a warranty on dose administration
page 6
Zeneo® - superior device: characteristics
 Needle-free auto injector for a better compliance
 Intramuscular,
 Subcutaneous,
 Intra dermal.
 1/10s auto-injection : improving medical benefit
for acute care and emergency uses = a warranty on dose
 Pre-filled & Single-use (disposable)
 Drug volume range: 0.1–0.6ml
 User-friendly, not syringe-like design, just “place & push”
 Convenient size, very fast, very easy
 Clinically proven, well-established technology
 Adapted from air bag/seat belt systems technology
 Adaptable to product viscosity

page 7
Zeneo® Ensures Delivery of Full Prescribed Dose
Open ZENEO®
 ZENEO is ready for injection
Apply on Injection Site & Push
 Arm, Stomach, Thigh…
 Automatic injection process (no button)
Just Hear the Click
 Injection is completed in less than 0.1s
Either you inject, or you do not inject…
but you can not miss you injection!
page 8
 Clinically proven: >10 000 tests on human skin & >300 on patients
 Different injection routes : SQ, IM, ID
 Different injection sites: shoulder, tight, abdomen
 Different viscosities (including very high viscous gels)
 Different molecules, including DNA, therapeutic proteins, suspensions...
 High preference to ZENEO for self injection
Standard materials in pharmaceutical sub-assembly
 Minimised regulatory burden – comparability with original syringes
 Use conventional syringe/cartridge automated filling technologies
Easy to customize
 No need for drug reformulation
 Shorter Pharmaceutical & regulatory route
Robust supply chain
 Expert industrial partners
Broad & Strong IP protection
 380 + patents worldwide in 26 families with life up to 2026
Zeneo® - an advanced proprietary platform
A combination
of technologies
for patient care
page 9
“End-user” validation: perfect for self-administration
 3 studies independently conducted by 3 big Pharma partners
 Health care staff (Dermatologists, rheumatologists, nurses) & patients.
 France (Paris, Lille), Germany, Spain, UK, USA (New York)
 “Crossject device meets expectations and is close to the ideal
device”
 Ease of handling
 minimized training requirements,
 high level of comfort,
 highly effective in reducing needle-stick injury,
 extremely safe device to use.
 “ Physicians confirm that Zeneo® device would positively
influence their prescription of a biologic product ”
page 10
A clinically validated technology : Results with GSK on vaccines
page 11
AN INTERNATIONALLY AWARD WINNING DESIGN
page 12
 As a combination product (drug + device), prefilled and single
use, ZENEO is registered as a drug
 Each drug combined with ZENEO will need an approval
 For Drugs already registered
 Registration process similar to generic products
 Only demonstrating:
• Equivalence to needle/syringe (bioequivalence)
• Safety with the device
 No risks
• Everything from the drug is already well known from us and from the
authorities
 Similar procedures world-wide
 Especially for SuperGenerics
A straightforward regulatory process
2. Crossject Offer
page 14
3 Market segments for ZENEO
1. Biologics and Vaccines
 Self-administration
 Avoids needle-phobia
 Avoids viral cross contamination
 Intra-dermal a practical possibility
 No need for adjuvant (intra dermal)
 Avoids needle-phobia
2. Biosimilars
 As above, co-developed only
 Customers: innovator companies: life-cycle management. Generics
majors.
3. SuperGenerics
 CJ development – ‘turnkey’ offerings are possible
 The device adds the value (IP)
 Self-administration
 Preferred injectable version of previously oral drugs
 Wide variety of possible customers
page 15
Crossject
 French Company founded in 2001, based in Dijon
 Spin-Off from Fournier Laboratories
 Crossject Staff: 14 people + partners
 Key competencies:
 Research, Mechanical Design & Engineering, Testing,
 Industrial development,
 Biopharmaceuticals
 QA
 Long development history; well-characterised device
 Strong Industrial partnerships
 Solid mastering of COG
 High potential but focus on turn key SuperGenerics
 Distribution licences
page 16
The ZENEO™ devices : needle free self injector
 A pharmaceutical sub-assembly

 An actuator
Casing
Gas generator
Trigger
Body
Cap
Membrane
Drug container
Nozzle
page 17
Customisable device : unique versatility
Injection nozzle:
number and size of orifice(s)
Drug container:
Type I glass or polymer (COC/COP)
Gas generator: customisable
pressure profile
Standard rubber stoppers
(formulation chosen by customer)
• Simple adaptations for route of administration
(SQ IM ID), volume and drug characteristics
• Primary packaging materials specified by
customer to reduce risks of drug/container issues
page 18
Industrial Flow: extended company
Full preparation
Aseptic Filling
Assembly
(secondary packaging)
Mechanical assembly
page 19
 Biologics, Biosimilars & Vaccines:
 Co-development with pharmaceutical companies
 Licence for use with their drugs
• Therapeutic Area / Worldwide exclusivity
 Sales of devices
 Filling/Packaging services purchased to RECIPHARM
Service Products (SuperGenerics)
 Development by CROSSJECT
 Or with partner
 Distribution licences
 Turnkey product (device + drug)
 Sales price including royalties
CROSSJECT Offers
page 20
Short term: Super Generic is the value added strategy
for ZENEO in a life cycle management process
page 21
3 SuperGenerics under development
 Combination products developed by CROSSJECT
 Distribution licenses proposed to pharmaceutical companies
 Country/country or Region/Region or Worldwide
 METHOTREXATE (rheumatoid arthritis)
 SQ
 7,5mg, 10mg, 15mg, 20mg & 25mg
 EPINEPHRINE (anaphylactic shock)
 IM
 0,15mg and 0,3mg (0,5mg)
 SUMATRIPTAN (acute migraine)
 SQ
 6mg
page 22
page 23
page 24
Zeneo® advantage: no needle-stick injury
 High exposure:
12 billion injections/year worldwide
 2 million infections in 35 million Health Care
Workers annually
 800 000 needle-stick injuries are reported
in the US each year, inducing an average cost
of $ 1000 per injury (excl. contamination)
 Safety devices for the injections mandated
in the US
 Through use of needles, unsafe injections cause
millions infections per year in particular:
 Hepatitis B
 Hepatitis C
 HIV
Source: ISIPS 2004
page 25
Zeneo® advantage: no needle phobia
 Needle phobia is a defined condition that affects
more than 10% (7-22%) of the general population*
 More than 15 million American adults and 5
million children suffer from high discomfort with
injections
 Needle phobia leads to avoidance which may
have severe medical consequences including
death
Roche says that of patients not receiving Fuzeon despite being
eligible, 4 out of 5 cite fear of injection as the main reason
(Scrip, 2004)
Source: * American Psychiatric Association
page 26
 Ease of use:
 Safety & reliability for professional and patient
 Suitable for self-injection, particularly for populations with
chronic treatments
 0,1 second self-injection by “place & push” ensuring
the right dose for acute care and emergency case
 Elimination of risk of needle-stick injury
 2 million infections in 35 million Health Care Workers
annually
 Through use of needles, unsafe injections cause millions
infections per year in particular Hepatitis B, Hepatitis C,
HIV
Zeneo® advantages
 Elimination of needle phobia
 Needle phobia is a defined condition that affects more than 10% (7-22%) of
the general population (up to 30% if discomfort with needles)
 Needle phobia leads to avoidance which may have severe medical consequences
including death
Source: ISIPS 2004
Source: * American Psychiatric Association
page 27
Zeneo® advantages
 Accuracy of dosing:
 Compliance assured (if the injection is made…)
 Many classical syringe injections are thought
to be inappropriate dose and/or injected
at the wrong depth
 ID particularly difficult to achieve correctly
with needles
 Shorter duration of pain and user-
friendly device improve prospects of
injections being made
 87 % of subjects would prefer ZENEO®
over needle for self injection in chronic
treatments
page 28
ZENEO compatible with many drugs, incl. biologics
The integrity of a wide range of drugs has been
checked successfully though “Stress Tests”:
 Therapeutic proteins : 2 MABs tested, Calcitonin*
 Low molecular weight heparins*
 Several vaccines **
• with and without alum adjuvant (suspensions)
 DNA vaccine
 Others (Sumatriptan*, ...)
* Includes successful PK or PD on pigs
** Successful clinical test with flu vaccine
ZENEO® & Anaphylactic Shock
page 30
Reference Product for IM adm. of Epinephrin
 Alternatives (all needle based)
 Anapen (Lincoln)
 E-Cue (Sanofi)
 Vibec (Antares)
MYLAN
Epipen
(needle-based)
 Worldwide leader
 >$500M sales expected for 2012
page 31
Key drawbacks of existing solutions (with needles)
 IM injection not guarantied into tie
 ZENEO demonstrated true IM injections clinically
 Injection time is too long (prep & injection)
 ZENEO injects within less than 50ms
 Preparation time for ZENEO very short (just remove cap & push onto
injection site)
 Others
 Needle Phobia
 Risk of needle-stick injury
 References
 Self-Injectable Adrenaline for Anaphylactic Emergencies: effectiveness of Epipen and Anapen...
Ram J Allergy & Therapy 2012 3:1
 Adequacy of the Epinephrine Auto injectors needle length in delivering epinephrine to the
muscular tissues – Ann Allergy Asthma Immunol 2005 May; 94(5):539-42
 Anaphylaxis: past, present, future – Allergy 66 (2011) 1-14
 What are the “ideal” features of an adrenaline auto-injector in the treatment of anaphylaxis –
Allergy 66 (2011) 15-24
 Comparison of the robustness and functionality of 3 adrenaline auto-injectors – Journal of
Asthma & Allergy 2012:5 39-49
page 32
Direct comparison ZENEO®/Needle Auto-Injectors
 IM Injection of blue coloured water through a piece of jeans
 Muscle shown on photos below (cross section near the injection site)
½ inch needle ZENEO
ZENEO® & Migraine
page 34
Reference Product for Needle-free adm. of Sumatriptan
 ZOGENIX launched DOSEPRO in 2011
 $30M Sales in 2011
 $40M Sales expected for 2012
 Sales Price = 105$
 83% prescriptions conversions from oral form
ZOGENIX (ZGNX)
DosePro
(needle-free 0,5ml/SQ)
 Approved in US and EU
 Regulatory path cleared
 Generic Path
 Fast
 No Risk
page 35
Clinical validation of the injection (SQ)
Arm Thigh Abdomen
0.5 ml 0.8 ml 0.8 ml
87 % of subjects would prefer ZENEO® over needle
for self injection in chronic treatments
Source: Internal Crossject clinical research
ZENEO® & Arthritis
page 37
RA requires highly ergonomic drug delivery system
 RA patients need life-long treatment
 Home treatment, with frequent injections.
Handling syringes is a challenge.
 Crossject contributes to improve the
patient care in this specific disabled
population:
 Ease of use facilitates self-injection
 Compliance, safety and reliability of
the injection.
 Rheumatoid Arthritis (RA) is
an auto-immune disease
(mainly in young women)
 The auto-immune drugs
market represents $10bn.
page 38
Reference Product self administration of Methotrexate
MEDAC
Metoject
 METHOTREXATE is a first line
treatment in RA:
 72% in first intention
 SQ injection of MTX gives better
response than oral MTX
 Injection often performed by a
nurse
page 39
“End-user” validation: perfect for self-administration
 3 studies independently conducted by 3 big Pharma partners
 Health care staff (Dermatologists, rheumatologists, nurses) & patients.
 France (Paris, Lille), Germany, Spain, UK, USA (New York)
 “Crossject device meets expectations and is close to the ideal
device”
 Ease of handling
 minimized training requirements,
 high level of comfort,
 highly effective in reducing needle-stick injury,
 extremely safe device to use.
 “ Physicians confirm that Zeneo® device would positively
influence their prescription of a biologic product ”
page 40
Clinical validation of the injection (SQ)
Arm Thigh Abdomen
0.5 ml 0.8 ml 0.8 ml
87 % of subjects would prefer ZENEO® over needle
for self injection in chronic treatments
Source: Internal Crossject clinical research
Future development for ZENEO®
page 42
Other applications for ZENEO technology
Intravitreal injections
 For retinopathies, glaucoma, allergies, etc.
 Injection of very small injection volumes (<0,1ml)
• Precision
• Reduced risks of eye damaging
 Ex vivo results already available with ZENEO
• Proof of concept : passed
 Ergonomics will need to be adapted to eye
 Co-development on-going with pharmaceutical company
• Therapeutic areas available for partnering
(26G Needle) (ZENEO)
page 43
Other applications for ZENEO technology
Ready to Fill & Polymer Drug Container
 Allowing customers to manufacture with
their own equipment
High Injection Volumes (1ml and over)
 Suited for modern biological products
Specific galenic forms of drugs (ZENEO
compatible)
 Suspensions, emulsions, gels…
• Perfectly suitable for fragile or poorly soluble
biologics
• Allow sustained/controlled release
Specific ergonomics
 Animal health
 Cosmetics
Market segments for ZENEO®
page 45
LMWH
Anti-TNF
G-CSF
EPO
a-interferons
b-interferons
Vaccines
Others
2.1. Crossject Target Markets within Biologics
Adjustable doses /
Intravenous injection
e.g. Insulin, HgH, Herceptin
Fixed doses /
Subcutaneous, Intramuscular,
Intradermal injections
Source: Contract Pharma – July/August 2011 – Top 50 Biologics
$51.3bn
$67.7bn
page 46
2.2 Biosimilars
Fast growing market – $3.7bn by 2014 (70%CAGR
2009–2015)*
30+ branded bio products off-patent 2011-2015
 Sales of $51bn will lose their patent exclusivity
 Regulatory pathway relatively recently defined
 Several major Bio-pharma companies and generics
specialists active in this new field
Product differentiation will be a key advantage
Products hard to copy – more expensive than small
molecule generics
 Partnered, not Crossject own development
* USA and 5 major EU markets. Source: Datamonitor published on 23 February 2011
page 47
2.3 SuperGenerics
 Premium prices up to x50 compared to basic syringe
or vial presentation
 Selection
o rheumatoid arthritis (methotrexate):
o acute migraine (triptan) :
o Anaphylactic shock (epinephrine) :
 And many other potential drugs: LMWH, Type 2
diabetes, Fertility, Erectile Dysfunction, Acute Pain
Relief, Inflammatory Burden, Psychiatry, Local
Analgesia, B12 vitamin, Testosterone, etc.
 SuperGeneric product : the added-value comes from the device
- safe, convenient, no phobia, patented, differentiated
page 48
MARKET DRIVERS
Obvious medical needs
 Needle-free systems will be reference for emergency needs:
anaphylaxis, inflammatory burden, acute pain ...
Pharmacoeconomy trends
 Self injection at home for chronic disease (reduces disease
cost management for health care agencies)
page 49
Unmet needs  Self Administration (1)
“Poor adherence to long-term treatment of chronic
diseases is a worldwide problem”
 “Adherence to long-term therapy for chronic illnesses in developed
countries averages 50%”.
 “Better adherence can produce better health outcomes and limit health
care expenditures”
Source World Health Organization
“NHS reforms have for the first time given real incentives
for NHS hospitals to reduce the length of time their
patients spend in hospital”.
 “Reducing hospital admissions and caring for people more appropriately
outside of hospital is key”.
 “When hospital care is needed, the NHS needs to minimise that time,
whilst not undermining patient safety or quality of care”.
page 50
Unmet needs  Self Administration (2)
“Outpatient pharmacotherapy of chronic
diseases relies on drug self
administration at home”
The EIP Strategic Implementation Plan
identifies 14 priorities
 N°1: identifying innovative solutions to ensure
better adherence to treatment
 N°4; promoting integrated care models for chronic
diseases, including the use of remote monitoring
page 51
Contact for partnering
Tim MULLER, Chief Business Officer & Executive Board Member
emails : tm@scientex.eu or t.muller@crossject.com
Mobile : +33 (0) 645 523 540 (main) or +33 (0) 602 510 791 (secondary) -
Office phone : +33 (0)977 1956 79
page 52

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Crossject self & safe needle-free auto-injectors sc im & id - partnering offer april 2013

  • 1. page 1 OUR GOAL IS TO DEVELOP SELF - ADMINISTERED PARENTERAL MEDICINES BASED ON OUR TRUE IM, SC & ID NEEDLE-FREE AUTO- INJECTORS THAT OPTIMIZE CLINICAL BENEFITS , PATIENTS COMPLIANCE WITH ENHANCED COST EFFECTIVE HEALTH OUTCOMES
  • 2. page 2 SUMMARY  THE DEVICE  Full prescribed dose delivered in <1/10s 3  CROSSJECT OFFER  Biologics & Super-Generics 11  APPENDICES 20 ZENEO® & Anaphylactic Shock 27 ZENEO® & Migraine 31 ZENEO® & Arthritis 35 Future development for ZENEO 40 Market segments for ZENEO 43  CONTACT 50  PRESS RELEASE ON LAST PARTNERING DEAL 51
  • 3. 1. The device – ZENEO® Superior patented devices for the needle-free injection of drugs Easy – Fast & Safe
  • 4. page 4 “Poor adherence to long-term treatment of chronic diseases is a worldwide problem” (according to WHO):  Adherence in developed countries averages 50%  Better adherence can produce better health outcomes and limit health care expenditures Reducing hospital admissions and caring for people more appropriately outside of hospital is key.  Outpatient pharmacotherapy of chronic diseases relies on drug self administration at home  Needs Increase with Ageing Population Self Administration : An Inevitable Evolution
  • 5. page 5 Zeneo® advantage: ease & safety of use Ease of use facilitates self-injection, particularly for populations requiring chronic treatment. No needle-phobia; no needle-stick risk  Increased compliance  Safety  Reliability Decreased « Social stigma » of the injectable chronic treatments, allowing a broader acceptance. Self-Injection by “place and push” in <0.1 second : a warranty on dose administration
  • 6. page 6 Zeneo® - superior device: characteristics  Needle-free auto injector for a better compliance  Intramuscular,  Subcutaneous,  Intra dermal.  1/10s auto-injection : improving medical benefit for acute care and emergency uses = a warranty on dose  Pre-filled & Single-use (disposable)  Drug volume range: 0.1–0.6ml  User-friendly, not syringe-like design, just “place & push”  Convenient size, very fast, very easy  Clinically proven, well-established technology  Adapted from air bag/seat belt systems technology  Adaptable to product viscosity 
  • 7. page 7 Zeneo® Ensures Delivery of Full Prescribed Dose Open ZENEO®  ZENEO is ready for injection Apply on Injection Site & Push  Arm, Stomach, Thigh…  Automatic injection process (no button) Just Hear the Click  Injection is completed in less than 0.1s Either you inject, or you do not inject… but you can not miss you injection!
  • 8. page 8  Clinically proven: >10 000 tests on human skin & >300 on patients  Different injection routes : SQ, IM, ID  Different injection sites: shoulder, tight, abdomen  Different viscosities (including very high viscous gels)  Different molecules, including DNA, therapeutic proteins, suspensions...  High preference to ZENEO for self injection Standard materials in pharmaceutical sub-assembly  Minimised regulatory burden – comparability with original syringes  Use conventional syringe/cartridge automated filling technologies Easy to customize  No need for drug reformulation  Shorter Pharmaceutical & regulatory route Robust supply chain  Expert industrial partners Broad & Strong IP protection  380 + patents worldwide in 26 families with life up to 2026 Zeneo® - an advanced proprietary platform A combination of technologies for patient care
  • 9. page 9 “End-user” validation: perfect for self-administration  3 studies independently conducted by 3 big Pharma partners  Health care staff (Dermatologists, rheumatologists, nurses) & patients.  France (Paris, Lille), Germany, Spain, UK, USA (New York)  “Crossject device meets expectations and is close to the ideal device”  Ease of handling  minimized training requirements,  high level of comfort,  highly effective in reducing needle-stick injury,  extremely safe device to use.  “ Physicians confirm that Zeneo® device would positively influence their prescription of a biologic product ”
  • 10. page 10 A clinically validated technology : Results with GSK on vaccines
  • 11. page 11 AN INTERNATIONALLY AWARD WINNING DESIGN
  • 12. page 12  As a combination product (drug + device), prefilled and single use, ZENEO is registered as a drug  Each drug combined with ZENEO will need an approval  For Drugs already registered  Registration process similar to generic products  Only demonstrating: • Equivalence to needle/syringe (bioequivalence) • Safety with the device  No risks • Everything from the drug is already well known from us and from the authorities  Similar procedures world-wide  Especially for SuperGenerics A straightforward regulatory process
  • 14. page 14 3 Market segments for ZENEO 1. Biologics and Vaccines  Self-administration  Avoids needle-phobia  Avoids viral cross contamination  Intra-dermal a practical possibility  No need for adjuvant (intra dermal)  Avoids needle-phobia 2. Biosimilars  As above, co-developed only  Customers: innovator companies: life-cycle management. Generics majors. 3. SuperGenerics  CJ development – ‘turnkey’ offerings are possible  The device adds the value (IP)  Self-administration  Preferred injectable version of previously oral drugs  Wide variety of possible customers
  • 15. page 15 Crossject  French Company founded in 2001, based in Dijon  Spin-Off from Fournier Laboratories  Crossject Staff: 14 people + partners  Key competencies:  Research, Mechanical Design & Engineering, Testing,  Industrial development,  Biopharmaceuticals  QA  Long development history; well-characterised device  Strong Industrial partnerships  Solid mastering of COG  High potential but focus on turn key SuperGenerics  Distribution licences
  • 16. page 16 The ZENEO™ devices : needle free self injector  A pharmaceutical sub-assembly   An actuator Casing Gas generator Trigger Body Cap Membrane Drug container Nozzle
  • 17. page 17 Customisable device : unique versatility Injection nozzle: number and size of orifice(s) Drug container: Type I glass or polymer (COC/COP) Gas generator: customisable pressure profile Standard rubber stoppers (formulation chosen by customer) • Simple adaptations for route of administration (SQ IM ID), volume and drug characteristics • Primary packaging materials specified by customer to reduce risks of drug/container issues
  • 18. page 18 Industrial Flow: extended company Full preparation Aseptic Filling Assembly (secondary packaging) Mechanical assembly
  • 19. page 19  Biologics, Biosimilars & Vaccines:  Co-development with pharmaceutical companies  Licence for use with their drugs • Therapeutic Area / Worldwide exclusivity  Sales of devices  Filling/Packaging services purchased to RECIPHARM Service Products (SuperGenerics)  Development by CROSSJECT  Or with partner  Distribution licences  Turnkey product (device + drug)  Sales price including royalties CROSSJECT Offers
  • 20. page 20 Short term: Super Generic is the value added strategy for ZENEO in a life cycle management process
  • 21. page 21 3 SuperGenerics under development  Combination products developed by CROSSJECT  Distribution licenses proposed to pharmaceutical companies  Country/country or Region/Region or Worldwide  METHOTREXATE (rheumatoid arthritis)  SQ  7,5mg, 10mg, 15mg, 20mg & 25mg  EPINEPHRINE (anaphylactic shock)  IM  0,15mg and 0,3mg (0,5mg)  SUMATRIPTAN (acute migraine)  SQ  6mg
  • 24. page 24 Zeneo® advantage: no needle-stick injury  High exposure: 12 billion injections/year worldwide  2 million infections in 35 million Health Care Workers annually  800 000 needle-stick injuries are reported in the US each year, inducing an average cost of $ 1000 per injury (excl. contamination)  Safety devices for the injections mandated in the US  Through use of needles, unsafe injections cause millions infections per year in particular:  Hepatitis B  Hepatitis C  HIV Source: ISIPS 2004
  • 25. page 25 Zeneo® advantage: no needle phobia  Needle phobia is a defined condition that affects more than 10% (7-22%) of the general population*  More than 15 million American adults and 5 million children suffer from high discomfort with injections  Needle phobia leads to avoidance which may have severe medical consequences including death Roche says that of patients not receiving Fuzeon despite being eligible, 4 out of 5 cite fear of injection as the main reason (Scrip, 2004) Source: * American Psychiatric Association
  • 26. page 26  Ease of use:  Safety & reliability for professional and patient  Suitable for self-injection, particularly for populations with chronic treatments  0,1 second self-injection by “place & push” ensuring the right dose for acute care and emergency case  Elimination of risk of needle-stick injury  2 million infections in 35 million Health Care Workers annually  Through use of needles, unsafe injections cause millions infections per year in particular Hepatitis B, Hepatitis C, HIV Zeneo® advantages  Elimination of needle phobia  Needle phobia is a defined condition that affects more than 10% (7-22%) of the general population (up to 30% if discomfort with needles)  Needle phobia leads to avoidance which may have severe medical consequences including death Source: ISIPS 2004 Source: * American Psychiatric Association
  • 27. page 27 Zeneo® advantages  Accuracy of dosing:  Compliance assured (if the injection is made…)  Many classical syringe injections are thought to be inappropriate dose and/or injected at the wrong depth  ID particularly difficult to achieve correctly with needles  Shorter duration of pain and user- friendly device improve prospects of injections being made  87 % of subjects would prefer ZENEO® over needle for self injection in chronic treatments
  • 28. page 28 ZENEO compatible with many drugs, incl. biologics The integrity of a wide range of drugs has been checked successfully though “Stress Tests”:  Therapeutic proteins : 2 MABs tested, Calcitonin*  Low molecular weight heparins*  Several vaccines ** • with and without alum adjuvant (suspensions)  DNA vaccine  Others (Sumatriptan*, ...) * Includes successful PK or PD on pigs ** Successful clinical test with flu vaccine
  • 30. page 30 Reference Product for IM adm. of Epinephrin  Alternatives (all needle based)  Anapen (Lincoln)  E-Cue (Sanofi)  Vibec (Antares) MYLAN Epipen (needle-based)  Worldwide leader  >$500M sales expected for 2012
  • 31. page 31 Key drawbacks of existing solutions (with needles)  IM injection not guarantied into tie  ZENEO demonstrated true IM injections clinically  Injection time is too long (prep & injection)  ZENEO injects within less than 50ms  Preparation time for ZENEO very short (just remove cap & push onto injection site)  Others  Needle Phobia  Risk of needle-stick injury  References  Self-Injectable Adrenaline for Anaphylactic Emergencies: effectiveness of Epipen and Anapen... Ram J Allergy & Therapy 2012 3:1  Adequacy of the Epinephrine Auto injectors needle length in delivering epinephrine to the muscular tissues – Ann Allergy Asthma Immunol 2005 May; 94(5):539-42  Anaphylaxis: past, present, future – Allergy 66 (2011) 1-14  What are the “ideal” features of an adrenaline auto-injector in the treatment of anaphylaxis – Allergy 66 (2011) 15-24  Comparison of the robustness and functionality of 3 adrenaline auto-injectors – Journal of Asthma & Allergy 2012:5 39-49
  • 32. page 32 Direct comparison ZENEO®/Needle Auto-Injectors  IM Injection of blue coloured water through a piece of jeans  Muscle shown on photos below (cross section near the injection site) ½ inch needle ZENEO
  • 34. page 34 Reference Product for Needle-free adm. of Sumatriptan  ZOGENIX launched DOSEPRO in 2011  $30M Sales in 2011  $40M Sales expected for 2012  Sales Price = 105$  83% prescriptions conversions from oral form ZOGENIX (ZGNX) DosePro (needle-free 0,5ml/SQ)  Approved in US and EU  Regulatory path cleared  Generic Path  Fast  No Risk
  • 35. page 35 Clinical validation of the injection (SQ) Arm Thigh Abdomen 0.5 ml 0.8 ml 0.8 ml 87 % of subjects would prefer ZENEO® over needle for self injection in chronic treatments Source: Internal Crossject clinical research
  • 37. page 37 RA requires highly ergonomic drug delivery system  RA patients need life-long treatment  Home treatment, with frequent injections. Handling syringes is a challenge.  Crossject contributes to improve the patient care in this specific disabled population:  Ease of use facilitates self-injection  Compliance, safety and reliability of the injection.  Rheumatoid Arthritis (RA) is an auto-immune disease (mainly in young women)  The auto-immune drugs market represents $10bn.
  • 38. page 38 Reference Product self administration of Methotrexate MEDAC Metoject  METHOTREXATE is a first line treatment in RA:  72% in first intention  SQ injection of MTX gives better response than oral MTX  Injection often performed by a nurse
  • 39. page 39 “End-user” validation: perfect for self-administration  3 studies independently conducted by 3 big Pharma partners  Health care staff (Dermatologists, rheumatologists, nurses) & patients.  France (Paris, Lille), Germany, Spain, UK, USA (New York)  “Crossject device meets expectations and is close to the ideal device”  Ease of handling  minimized training requirements,  high level of comfort,  highly effective in reducing needle-stick injury,  extremely safe device to use.  “ Physicians confirm that Zeneo® device would positively influence their prescription of a biologic product ”
  • 40. page 40 Clinical validation of the injection (SQ) Arm Thigh Abdomen 0.5 ml 0.8 ml 0.8 ml 87 % of subjects would prefer ZENEO® over needle for self injection in chronic treatments Source: Internal Crossject clinical research
  • 42. page 42 Other applications for ZENEO technology Intravitreal injections  For retinopathies, glaucoma, allergies, etc.  Injection of very small injection volumes (<0,1ml) • Precision • Reduced risks of eye damaging  Ex vivo results already available with ZENEO • Proof of concept : passed  Ergonomics will need to be adapted to eye  Co-development on-going with pharmaceutical company • Therapeutic areas available for partnering (26G Needle) (ZENEO)
  • 43. page 43 Other applications for ZENEO technology Ready to Fill & Polymer Drug Container  Allowing customers to manufacture with their own equipment High Injection Volumes (1ml and over)  Suited for modern biological products Specific galenic forms of drugs (ZENEO compatible)  Suspensions, emulsions, gels… • Perfectly suitable for fragile or poorly soluble biologics • Allow sustained/controlled release Specific ergonomics  Animal health  Cosmetics
  • 45. page 45 LMWH Anti-TNF G-CSF EPO a-interferons b-interferons Vaccines Others 2.1. Crossject Target Markets within Biologics Adjustable doses / Intravenous injection e.g. Insulin, HgH, Herceptin Fixed doses / Subcutaneous, Intramuscular, Intradermal injections Source: Contract Pharma – July/August 2011 – Top 50 Biologics $51.3bn $67.7bn
  • 46. page 46 2.2 Biosimilars Fast growing market – $3.7bn by 2014 (70%CAGR 2009–2015)* 30+ branded bio products off-patent 2011-2015  Sales of $51bn will lose their patent exclusivity  Regulatory pathway relatively recently defined  Several major Bio-pharma companies and generics specialists active in this new field Product differentiation will be a key advantage Products hard to copy – more expensive than small molecule generics  Partnered, not Crossject own development * USA and 5 major EU markets. Source: Datamonitor published on 23 February 2011
  • 47. page 47 2.3 SuperGenerics  Premium prices up to x50 compared to basic syringe or vial presentation  Selection o rheumatoid arthritis (methotrexate): o acute migraine (triptan) : o Anaphylactic shock (epinephrine) :  And many other potential drugs: LMWH, Type 2 diabetes, Fertility, Erectile Dysfunction, Acute Pain Relief, Inflammatory Burden, Psychiatry, Local Analgesia, B12 vitamin, Testosterone, etc.  SuperGeneric product : the added-value comes from the device - safe, convenient, no phobia, patented, differentiated
  • 48. page 48 MARKET DRIVERS Obvious medical needs  Needle-free systems will be reference for emergency needs: anaphylaxis, inflammatory burden, acute pain ... Pharmacoeconomy trends  Self injection at home for chronic disease (reduces disease cost management for health care agencies)
  • 49. page 49 Unmet needs  Self Administration (1) “Poor adherence to long-term treatment of chronic diseases is a worldwide problem”  “Adherence to long-term therapy for chronic illnesses in developed countries averages 50%”.  “Better adherence can produce better health outcomes and limit health care expenditures” Source World Health Organization “NHS reforms have for the first time given real incentives for NHS hospitals to reduce the length of time their patients spend in hospital”.  “Reducing hospital admissions and caring for people more appropriately outside of hospital is key”.  “When hospital care is needed, the NHS needs to minimise that time, whilst not undermining patient safety or quality of care”.
  • 50. page 50 Unmet needs  Self Administration (2) “Outpatient pharmacotherapy of chronic diseases relies on drug self administration at home” The EIP Strategic Implementation Plan identifies 14 priorities  N°1: identifying innovative solutions to ensure better adherence to treatment  N°4; promoting integrated care models for chronic diseases, including the use of remote monitoring
  • 51. page 51 Contact for partnering Tim MULLER, Chief Business Officer & Executive Board Member emails : tm@scientex.eu or t.muller@crossject.com Mobile : +33 (0) 645 523 540 (main) or +33 (0) 602 510 791 (secondary) - Office phone : +33 (0)977 1956 79