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

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

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

“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

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

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


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!

 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

“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 ”

A clinically validated technology : Results with GSK on vaccines

AN INTERNATIONALLY AWARD WINNING DESIGN

 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

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

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

The ZENEO™ devices : needle free self injector
 A pharmaceutical sub-assembly

 An actuator
Casing
Gas generator
Trigger
Body
Cap
Membrane
Drug container
Nozzle

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

Industrial Flow: extended company
Full preparation
Aseptic Filling
Assembly
(secondary packaging)
Mechanical assembly

 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

Short term: Super Generic is the value added strategy
for ZENEO in a life cycle management process

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

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

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

 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

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

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

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

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

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

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

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

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.

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

Future development for ZENEO®

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)

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

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

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

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

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)

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”.

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

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

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

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