page 1OUR GOAL IS TO DEVELOP SELF - ADMINISTERED PARENTERALMEDICINES BASED ON OUR TRUE IM, SC & ID NEEDLE-FREE AUTO-INJECT...
page 2SUMMARY THE DEVICE Full prescribed dose delivered in <1/10s 3 CROSSJECT OFFER Biologics & Super-Generics 11 APP...
1. The device – ZENEO®Superior patented devices forthe needle-free injection of drugsEasy – Fast & Safe
page 4“Poor adherence to long-term treatment of chronic diseases is a worldwideproblem” (according to WHO): Adherence in...
page 5Zeneo® advantage: ease & safety of useEase of use facilitates self-injection,particularly for populations requiring...
page 6Zeneo® - superior device: characteristics Needle-free auto injector for a better compliance Intramuscular, Subcut...
page 7Zeneo® Ensures Delivery of Full Prescribed DoseOpen ZENEO® ZENEO is ready for injectionApply on Injection Site & ...
page 8 Clinically proven: >10 000 tests on human skin & >300 on patients Different injection routes : SQ, IM, ID Differ...
page 9“End-user” validation: perfect for self-administration 3 studies independently conducted by 3 big Pharma partners ...
page 10A clinically validated technology : Results with GSK on vaccines
page 11AN INTERNATIONALLY AWARD WINNING DESIGN
page 12 As a combination product (drug + device), prefilled and singleuse, ZENEO is registered as a drug Each drug combi...
2. Crossject Offer
page 143 Market segments for ZENEO1. Biologics and Vaccines Self-administration Avoids needle-phobia Avoids viral cross...
page 15Crossject French Company founded in 2001, based in Dijon Spin-Off from Fournier Laboratories Crossject Staff: 14...
page 16The ZENEO™ devices : needle free self injector A pharmaceutical sub-assembly An actuatorCasingGas generatorTrigg...
page 17Customisable device : unique versatilityInjection nozzle:number and size of orifice(s)Drug container:Type I glass o...
page 18Industrial Flow: extended companyFull preparationAseptic FillingAssembly(secondary packaging)Mechanical assembly
page 19 Biologics, Biosimilars & Vaccines: Co-development with pharmaceutical companies Licence for use with their drug...
page 20Short term: Super Generic is the value added strategyfor ZENEO in a life cycle management process
page 213 SuperGenerics under development Combination products developed by CROSSJECT Distribution licenses proposed to p...
page 22
page 23
page 24Zeneo® advantage: no needle-stick injury High exposure:12 billion injections/year worldwide 2 million infections ...
page 25Zeneo® advantage: no needle phobia Needle phobia is a defined condition that affectsmore than 10% (7-22%) of the g...
page 26 Ease of use: Safety & reliability for professional and patient Suitable for self-injection, particularly for po...
page 27Zeneo® advantages Accuracy of dosing: Compliance assured (if the injection is made…) Many classical syringe inje...
page 28ZENEO compatible with many drugs, incl. biologicsThe integrity of a wide range of drugs has beenchecked successful...
ZENEO® & Anaphylactic Shock
page 30Reference Product for IM adm. of Epinephrin Alternatives (all needle based) Anapen (Lincoln) E-Cue (Sanofi) Vib...
page 31Key drawbacks of existing solutions (with needles) IM injection not guarantied into tie ZENEO demonstrated true I...
page 32Direct comparison ZENEO®/Needle Auto-Injectors IM Injection of blue coloured water through a piece of jeans Muscl...
ZENEO® & Migraine
page 34Reference Product for Needle-free adm. of Sumatriptan ZOGENIX launched DOSEPRO in 2011 $30M Sales in 2011 $40M S...
page 35Clinical validation of the injection (SQ)Arm Thigh Abdomen0.5 ml 0.8 ml 0.8 ml87 % of subjects would prefer ZENEO® ...
ZENEO® & Arthritis
page 37RA requires highly ergonomic drug delivery system RA patients need life-long treatment Home treatment, with frequ...
page 38Reference Product self administration of MethotrexateMEDACMetoject METHOTREXATE is a first linetreatment in RA: 7...
page 39“End-user” validation: perfect for self-administration 3 studies independently conducted by 3 big Pharma partners...
page 40Clinical validation of the injection (SQ)Arm Thigh Abdomen0.5 ml 0.8 ml 0.8 ml87 % of subjects would prefer ZENEO® ...
Future development for ZENEO®
page 42Other applications for ZENEO technologyIntravitreal injections For retinopathies, glaucoma, allergies, etc. Inje...
page 43Other applications for ZENEO technologyReady to Fill & Polymer Drug Container Allowing customers to manufacture w...
Market segments for ZENEO®
page 45LMWHAnti-TNFG-CSFEPOa-interferonsb-interferonsVaccinesOthers2.1. Crossject Target Markets within BiologicsAdjustabl...
page 462.2 BiosimilarsFast growing market – $3.7bn by 2014 (70%CAGR2009–2015)*30+ branded bio products off-patent 2011-2...
page 472.3 SuperGenerics Premium prices up to x50 compared to basic syringeor vial presentation Selectiono rheumatoid ar...
page 48MARKET DRIVERSObvious medical needs Needle-free systems will be reference for emergency needs:anaphylaxis, inflam...
page 49Unmet needs  Self Administration (1)“Poor adherence to long-term treatment of chronicdiseases is a worldwide prob...
page 50Unmet needs  Self Administration (2)“Outpatient pharmacotherapy of chronicdiseases relies on drug selfadministrat...
page 51Contact for partneringTim MULLER, Chief Business Officer & Executive Board Memberemails : tm@scientex.eu or t.mulle...
page 52
Upcoming SlideShare
Loading in …5
×

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

2,051 views

Published on

Published in: Business
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
2,051
On SlideShare
0
From Embeds
0
Number of Embeds
4
Actions
Shares
0
Downloads
0
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

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

  1. 1. page 1OUR GOAL IS TO DEVELOP SELF - ADMINISTERED PARENTERALMEDICINES BASED ON OUR TRUE IM, SC & ID NEEDLE-FREE AUTO-INJECTORS THAT OPTIMIZE CLINICAL BENEFITS , PATIENTSCOMPLIANCE WITH ENHANCED COST EFFECTIVE HEALTH OUTCOMES
  2. 2. page 2SUMMARY 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. 3. 1. The device – ZENEO®Superior patented devices forthe needle-free injection of drugsEasy – Fast & Safe
  4. 4. page 4“Poor adherence to long-term treatment of chronic diseases is a worldwideproblem” (according to WHO): Adherence in developed countries averages 50% Better adherence can produce better health outcomes and limit healthcare expendituresReducing hospital admissions and caring for people more appropriatelyoutside of hospital is key. Outpatient pharmacotherapy of chronic diseases relies on drug selfadministration at home Needs Increase with Ageing PopulationSelf Administration : An Inevitable Evolution
  5. 5. page 5Zeneo® advantage: ease & safety of useEase of use facilitates self-injection,particularly for populations requiring chronictreatment.No needle-phobia; no needle-stick risk Increased compliance Safety ReliabilityDecreased « Social stigma »of the injectable chronic treatments, allowing abroader acceptance.Self-Injection by “place and push” in <0.1second : a warranty on dose administration
  6. 6. page 6Zeneo® - superior device: characteristics Needle-free auto injector for a better compliance Intramuscular, Subcutaneous, Intra dermal. 1/10s auto-injection : improving medical benefitfor 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. 7. page 7Zeneo® 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 0.1sEither you inject, or you do not inject…but you can not miss you injection!
  8. 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 2026Zeneo® - an advanced proprietary platformA combinationof technologiesfor patient care
  9. 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 idealdevice” 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 positivelyinfluence their prescription of a biologic product ”
  10. 10. page 10A clinically validated technology : Results with GSK on vaccines
  11. 11. page 11AN INTERNATIONALLY AWARD WINNING DESIGN
  12. 12. page 12 As a combination product (drug + device), prefilled and singleuse, 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 theauthorities Similar procedures world-wide Especially for SuperGenericsA straightforward regulatory process
  13. 13. 2. Crossject Offer
  14. 14. page 143 Market segments for ZENEO1. 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-phobia2. Biosimilars As above, co-developed only Customers: innovator companies: life-cycle management. Genericsmajors.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. 15. page 15Crossject 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. 16. page 16The ZENEO™ devices : needle free self injector A pharmaceutical sub-assembly An actuatorCasingGas generatorTriggerBodyCapMembraneDrug containerNozzle
  17. 17. page 17Customisable device : unique versatilityInjection nozzle:number and size of orifice(s)Drug container:Type I glass or polymer (COC/COP)Gas generator: customisablepressure profileStandard rubber stoppers(formulation chosen by customer)• Simple adaptations for route of administration(SQ IM ID), volume and drug characteristics• Primary packaging materials specified bycustomer to reduce risks of drug/container issues
  18. 18. page 18Industrial Flow: extended companyFull preparationAseptic FillingAssembly(secondary packaging)Mechanical assembly
  19. 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 royaltiesCROSSJECT Offers
  20. 20. page 20Short term: Super Generic is the value added strategyfor ZENEO in a life cycle management process
  21. 21. page 213 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
  22. 22. page 22
  23. 23. page 23
  24. 24. page 24Zeneo® advantage: no needle-stick injury High exposure:12 billion injections/year worldwide 2 million infections in 35 million Health CareWorkers annually 800 000 needle-stick injuries are reportedin the US each year, inducing an average costof $ 1000 per injury (excl. contamination) Safety devices for the injections mandatedin the US Through use of needles, unsafe injections causemillions infections per year in particular: Hepatitis B Hepatitis C HIVSource: ISIPS 2004
  25. 25. page 25Zeneo® advantage: no needle phobia Needle phobia is a defined condition that affectsmore than 10% (7-22%) of the general population* More than 15 million American adults and 5million children suffer from high discomfort withinjections Needle phobia leads to avoidance which mayhave severe medical consequences includingdeathRoche says that of patients not receiving Fuzeon despite beingeligible, 4 out of 5 cite fear of injection as the main reason(Scrip, 2004)Source: * American Psychiatric Association
  26. 26. page 26 Ease of use: Safety & reliability for professional and patient Suitable for self-injection, particularly for populations withchronic treatments 0,1 second self-injection by “place & push” ensuringthe right dose for acute care and emergency case Elimination of risk of needle-stick injury 2 million infections in 35 million Health Care Workersannually Through use of needles, unsafe injections cause millionsinfections per year in particular Hepatitis B, Hepatitis C,HIVZeneo® advantages Elimination of needle phobia Needle phobia is a defined condition that affects more than 10% (7-22%) ofthe general population (up to 30% if discomfort with needles) Needle phobia leads to avoidance which may have severe medical consequencesincluding deathSource: ISIPS 2004Source: * American Psychiatric Association
  27. 27. page 27Zeneo® advantages Accuracy of dosing: Compliance assured (if the injection is made…) Many classical syringe injections are thoughtto be inappropriate dose and/or injectedat the wrong depth ID particularly difficult to achieve correctlywith needles Shorter duration of pain and user-friendly device improve prospects ofinjections being made 87 % of subjects would prefer ZENEO®over needle for self injection in chronictreatments
  28. 28. page 28ZENEO compatible with many drugs, incl. biologicsThe integrity of a wide range of drugs has beenchecked 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
  29. 29. ZENEO® & Anaphylactic Shock
  30. 30. page 30Reference Product for IM adm. of Epinephrin Alternatives (all needle based) Anapen (Lincoln) E-Cue (Sanofi) Vibec (Antares)MYLANEpipen(needle-based) Worldwide leader >$500M sales expected for 2012
  31. 31. page 31Key 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 ontoinjection 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 themuscular 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 ofAsthma & Allergy 2012:5 39-49
  32. 32. page 32Direct 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
  33. 33. ZENEO® & Migraine
  34. 34. page 34Reference 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 formZOGENIX (ZGNX)DosePro(needle-free 0,5ml/SQ) Approved in US and EU Regulatory path cleared Generic Path Fast No Risk
  35. 35. page 35Clinical validation of the injection (SQ)Arm Thigh Abdomen0.5 ml 0.8 ml 0.8 ml87 % of subjects would prefer ZENEO® over needlefor self injection in chronic treatmentsSource: Internal Crossject clinical research
  36. 36. ZENEO® & Arthritis
  37. 37. page 37RA 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 thepatient care in this specific disabledpopulation: Ease of use facilitates self-injection Compliance, safety and reliability ofthe injection. Rheumatoid Arthritis (RA) isan auto-immune disease(mainly in young women) The auto-immune drugsmarket represents $10bn.
  38. 38. page 38Reference Product self administration of MethotrexateMEDACMetoject METHOTREXATE is a first linetreatment in RA: 72% in first intention SQ injection of MTX gives betterresponse than oral MTX Injection often performed by anurse
  39. 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 idealdevice” 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 positivelyinfluence their prescription of a biologic product ”
  40. 40. page 40Clinical validation of the injection (SQ)Arm Thigh Abdomen0.5 ml 0.8 ml 0.8 ml87 % of subjects would prefer ZENEO® over needlefor self injection in chronic treatmentsSource: Internal Crossject clinical research
  41. 41. Future development for ZENEO®
  42. 42. page 42Other 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. 43. page 43Other applications for ZENEO technologyReady to Fill & Polymer Drug Container Allowing customers to manufacture withtheir own equipmentHigh Injection Volumes (1ml and over) Suited for modern biological productsSpecific galenic forms of drugs (ZENEOcompatible) Suspensions, emulsions, gels…• Perfectly suitable for fragile or poorly solublebiologics• Allow sustained/controlled releaseSpecific ergonomics Animal health Cosmetics
  44. 44. Market segments for ZENEO®
  45. 45. page 45LMWHAnti-TNFG-CSFEPOa-interferonsb-interferonsVaccinesOthers2.1. Crossject Target Markets within BiologicsAdjustable doses /Intravenous injectione.g. Insulin, HgH, HerceptinFixed doses /Subcutaneous, Intramuscular,Intradermal injectionsSource: Contract Pharma – July/August 2011 – Top 50 Biologics$51.3bn$67.7bn
  46. 46. page 462.2 BiosimilarsFast growing market – $3.7bn by 2014 (70%CAGR2009–2015)*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 genericsspecialists active in this new fieldProduct differentiation will be a key advantageProducts hard to copy – more expensive than smallmolecule generics Partnered, not Crossject own development* USA and 5 major EU markets. Source: Datamonitor published on 23 February 2011
  47. 47. page 472.3 SuperGenerics Premium prices up to x50 compared to basic syringeor vial presentation Selectiono rheumatoid arthritis (methotrexate):o acute migraine (triptan) :o Anaphylactic shock (epinephrine) : And many other potential drugs: LMWH, Type 2diabetes, Fertility, Erectile Dysfunction, Acute PainRelief, Inflammatory Burden, Psychiatry, LocalAnalgesia, B12 vitamin, Testosterone, etc. SuperGeneric product : the added-value comes from the device- safe, convenient, no phobia, patented, differentiated
  48. 48. page 48MARKET 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 diseasecost management for health care agencies)
  49. 49. page 49Unmet needs  Self Administration (1)“Poor adherence to long-term treatment of chronicdiseases is a worldwide problem” “Adherence to long-term therapy for chronic illnesses in developedcountries averages 50%”. “Better adherence can produce better health outcomes and limit healthcare expenditures”Source World Health Organization“NHS reforms have for the first time given real incentivesfor NHS hospitals to reduce the length of time theirpatients spend in hospital”. “Reducing hospital admissions and caring for people more appropriatelyoutside 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. 50. page 50Unmet needs  Self Administration (2)“Outpatient pharmacotherapy of chronicdiseases relies on drug selfadministration at home”The EIP Strategic Implementation Planidentifies 14 priorities N°1: identifying innovative solutions to ensurebetter adherence to treatment N°4; promoting integrated care models for chronicdiseases, including the use of remote monitoring
  51. 51. page 51Contact for partneringTim MULLER, Chief Business Officer & Executive Board Memberemails : tm@scientex.eu or t.muller@crossject.comMobile : +33 (0) 645 523 540 (main) or +33 (0) 602 510 791 (secondary) -Office phone : +33 (0)977 1956 79
  52. 52. page 52

×