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INJEX Needle-Free Drug Delivery Systems
INJEX Needle-Free Drug Delivery Systems TM A Technology Presentation by INJEX – Equidyne Systems Especially for Company History Injex™-Equidyne Systems, Inc. 1991 Founded and Incorporated in 1991 The founder was Stewart Parsons, an accomplished mechanical engineer with more than 50 issued U.S. Patents to his credit and Co-Inventor of the first GPS guidance systems. 1992-1998 Conducted R & D, Testing, Prototyping, and Clinical Studies at major hospitals. Injex products received FDA 510(k) as well as CE Mark Certification for sale of Injex™ in the European Union. Company History con’t 1999 Injex™ released for sale in the U.S. and European markets. 2004 Established Worldwide Distribution in more than 40 countries for Injex sales and distribution. The Company forms important Strategic Alliances with a few large pharmaceutical companies for use of their drugs in conjunction with Injex needle-free technology. Company History con’t 2005 Company completes purchase of assets of Rosch Medzintechnik, AG, Berlin, Germany, making Injex-Equidyne Systems, Inc., the world leader in needlefree technology. The Company is the only company in the needle-free industry that is currently profitable, and is debt free History of Needle-Free Jet Injection 1853 First hypodermic needle syringe, Charles G. Pravaz, France and Alexander Wood, USA 1866 Needle-free technique as “Aqua puncture,” by Dr. Beclard, France. 1936 First patent for “Jet Injection , to Marshall Lockhard, USA History of Needle-Free Jet Injection 1940 Development of reusable high-pressure “guns” for large scale vaccination programs (Hingson et al.) 1947-1965 Introduction of Jet Injection to clinical practice 1975-1995 Evolution of needle-free devices 1999 Introduction of INJEX™ Needle-Free Technology The Evolution 1960’s – Military utilized air powered gun that administered 6 vaccinations to troops at one time 1980’s – R & D CO2 powered injection devices 1990’s – More refinements newer Spring Powered devices emerge. Other improvements developed include orifice size, pressure controls, velocity of liquid stream, power curve, etc. Many clinical studies were conducted. Needle-Free Technology con’t. The Evolution 2003 – Injex 30 and Injex 50 emerge as cutting edge technology and becomes widely accepted in some markets. 2004 – Injex – Soft Shot TM technology is introduced. Hypodermic Needle Syringes History and Concerns * 75 Year old technology • Spreading of contagious diseases • Contaminated used needles • Improper disposal of dirty needles • Sharing of needle syringes • Pain experienced with needle injection • Needle phobia – Fear of shots • Children NAPPSI National Alliance for the Primary Prevention of Sharps Injuries The NAPPSI Primary and Secondary Prevention Needle Stick Safety Device List Injex recommended on NAPPSI list of devices to utilize as a primary prevention device to reduce exposure to potentially fatal injuries from needles. Injex – Benefits and Advantages • • • • • • • • • Virtually painless and needle-free Subcutaneous injection, tissue preserving Convenient for delivering variable doses Fast, easy and safe in use and effect No risk of needle-stick injuries Eliminates cross-contamination Reduces disposal costs User friendly, compact and can be used everywhere Easy to operate and long-lasting Injex -First Generation Needle-Free Injector 1992 • Designed to deliver liquid medicines through the skin by means of a thin high velocity stream of fluid without the use of a needle. • • Spring activated Re-usable for approx. 3,500 injections orifice plunger ampoule with liquid spring (charged) INJEX 50 Starter Kit Ampule and Vial Adapter Vial Adapter Sterile disposable adapter – Attaches to medication vial Ampule How Injex Penetrates the Skin Needle Syringe Pool of Medication Left by needle Needle-Free Injection Medication is Dispensed Uniformly in Spray Like Pattern Injex Clinical Results Thrombosis prophylaxis: LMW-Heparin Diabetes: Insulin VERSUS Local Anaesthesia: Lidocain Cancer (home-care): Cytokines: Interferon alpha Injex Insulin Kinetics Comparison of Blood Glucose and Insulin Kinetics following Injexand Pen Injection (Schatz,H., Pfohl,M. et al., Ruhr-Univ. Bochum) 36th Annual Conference of the German Diabetes Society (DDG), Aachen, 26.05.2001 Injex Blood Glucose Kinetics Comparison of Blood Glucose and Insulin Kinetics following Injexand Pen Injection (Schatz,H., Pfohl,M. et al., Ruhr-Univ. Bochum) 36th Annual Conference of the German Diabetes Society (DDG), Aachen, 26.05.2001 Injex Histology Investigation of depth of penetration and histologic dispersion of a dye injected with the INJEX-System (MeMiniportmbH/Rösch AG) Results: Depth of penetration : 3.2 – 9.1mm Pattern of spread of dye: conical, 5 – 18mm diameter Compartment : subcutis Additional Findings: Depth of penetration depends on the volume administered Intact epidermis without damage of underlying tissue Dye did not penetrate beyond the fascia into the skeletal muscle Injex Histology Investigation of depth of penetration and histologic dispersion of a dye injected with the INJEX-System (Mediport GmbH/Rösch AG) Epidermis Dermis Magnification: x 40 Injected volume: 100 µl Model-like spread of dye, ending in the s.c. connective tissue. Completely intact epidermis Injex Histology Epidermis Dermis Epidermis Subcutis Muscle © MediD esign The injected fluid (0.2ml) followed the fascia but did not enter the underlying muscle itself. Injex Molecular Integrity Investigation of structural features/efficacy of various compounds after application with Injex Results: No loss of drug efficacy Complete retention of molecular identity Complete retention of immunoreactivity Complete retention of tertiary structure Clinical Studies Vaccines – MMR Vaccine Clinical Immunogenicity of measles, mumps and rubella vaccine delivered by the INJEX needle free jet injection device: Comparison with standard needle syringe The MMR vaccine can be safely and effectively delivered by the Injex jet injector and is a safer alternative that might reduce needle stick accidents. Sarno, Mark J., BA, Blasé, Erich, BA, Galindo, Nelly, RN, Ramirez, Roberto, MD, Schirmer, Carl L., MS and Trujillo-Juarez, Daniel F., MD and Vision Biotech. Consulting, 2000. Pediatric Infectious Disease Journal, Vol. 19 No. 9, September 2000. * MMR – Trademark – Merck & Co. Clinical Studies con’t. Anesthesia Drugs – Subcutaneous Injury and Wound repair – Local Anesthetic A study using the INJEX with local anesthesia. The device offers advantages over the subcutaneous infiltration of various caine anesthetics via syringe an 30 gauge needle weather used with or without Fluori/methane when used in an outpatient clinical setting. Yale, William S., and Industrial Medical Clinics, Inc., 1999. Clinical Studies con’t. Insulin – Blood Sugar, Kinetics, and Structural Potency - Comparison with conventional pen; needle-free Injex controls blood sugar the same, lower pain level, and causes less skin irritation. Ehren, M., Lieder, O., Engelbert, S., Schatz, H., Pfohl, M., Medical University Clinic Bergmannsheil, Bochum, Germany, 2001. - Results demonstrate no loss in insulin potency after injection by either the Injex 30 or the syringe. Sarno, Mark J., Vision Biotechnology Consulting, 2000, Equidyne Systems, Inc. Clinical Studies con’t. Insulin – Fast Acting Types - Pharmacokinetics of Fast Acting Insulin when injected with the Injex needle-free injector versus a syringe and needle. Clinical Studies con’t. Cancer Therapy – Interferon - Patient compliance with prescribed drug regimens significantly improved, reducing overall healthcare costs by allowing treatment to be administered on an outpatient basis. Acanthos, at Fraunhofer Institute, Hanover, Germany, 2000. Patient Acceptance Preparation Insulin Dosing Skin Irritation Injection Pain Safety Com parison w ith Pen Future Use 1 1,5 2 2,5 3 3,5 4 4,5 5 Results of patient evaluations, of the Injex™ (based on the German school grading system, which starts at 1 (excellent) and ends at 6 (unsatisfactory). Injex Proprietary Technology • • • • • Needle-Free technology is heavily Patented 5 issued U.S. Patents Several Patents Pending Foreign Patents – China, Japan, S. Africa, etc. Trademarks Issued – INJEX , The Soft Shot Patents Protected and Methods: – – – – – • Ampule Design Adapters – 3 Types Manufacturing Automated Production Process PCT Patents Worldwide Regulatory Compliance • FDA (510 K) Clearance of INJEX™ systems • ISO-9001 and ISO-9002 Certifications for manufacturing facility at Anaheim, CA and Germany Manufacturing facilities • European CE Mark Certification (CE 0482) for pharmaceuticals suitable for subcutaneous jet-injection Injex Technology Spring powered medical device – Drug Delivery Disposable sterile medication cartridge (Ampule) Orifice .005 inches diameter Disposable How Injex Works Concept of Operation • Ampule is filled with drug • Ampule is attached to Injector • Coil spring is compressed inside Injector • Trigger is pressed, spring is released and pushes piston forward against plunger shaft • Fluid is rapidly expelled out ampule through very small orifice at tip (600 feet per second velocity) Prefilled Ampule Inert Cap • Glass lined • Filled at Pharma filling plant • We assist with filling equipment • Unit Dose Inert Seal Injex Product Configuration Options A. Reusable Injector with: - Variable dose (from Vial) - Unit dose (0.5 ml) or (1.0 ml) B. Reusable Injector with Pre-Filled dose C. All Disposable Injector with: - Variable dose ampule - Pre-filled ampule – Unit dose Applications Injex Needle-Free Injection Self-Administered drugs Vaccinations Drug Therapy Special Drug Applications Public Health - Worldwide Mass Public Immunization Immunization Programs Public Health World Health Organization- WHO Center for Disease Control- CDC International Sponsorship Self Administered Drugs List • Insulin – 50 years • Stroke Medications • Growth Hormone (HGH) – Children and Older People • Cardiovascular Drugs • Cancer - Interferon • Rheumatoid Arthritis – Embrel, Humira • Migraine headaches • Military Use – Chemical and Biological Gas, etc. Why Injex needle free injection? A better way to inject drugs • Virtually painless injection • Eliminates – – – – Sharing of needles by patients Risks associated with needles Contaminated needle exposure Hazardous waste disposal • Better medication absorption • Bioavailability equivalence Technological Advantages Factors To Be Considered Spring powered vs. CO2 gas cartridges Additional cost of CO2 cartridges – CO2 Size of device and ergonomics – Patient preference Cost of disposable Ampule – 1.0 ml Ease of use Variable gas pressure as CO2 runs low Over-powered CO2 start and underpowered at end World Headquarters and Facilities Injex – Equidyne Systems, Inc. Anaheim, CA USA Injex Production Facilities Two Production Facilities —Anaheim, California, USA —Gottingen, Germany ISO-9001 Certification – Both facilities CE Mark Certification – Germany produced products FDA 510(k) – All products (Both Facilities) Automated Production Line Gottingen, Germany ISO-9001 and CE Mark Certified Tooling & Injection Molding Equipment 8 each – 16 Cavity high performance injection ampule molds in U.S. Facility 9 each – 16 Cavity high performance injection ampule molds – Germany Facility 2 each – Automated assembly and packaging systems. Cost $2.4 Million each. Manufacturing Capacity / Output Ampules – Germany production 8 million pieces per month Ampules – U.S. production 7.5 million pieces per month INJEX 50 Injectors – 1 million per month Approximate capacity Technology Comparison List Factors to Consider FACTOR INJEX 1.0 ml. OTHER Injector cost – Estimate $70.00 Over $200 Disposable cost $ .35 Much more CO2 cartridges cost None Extra Size and weight 2.8 oz. 1.5 lb. User friendliness & ease of use Easy Complex Ergonomics & convenience Excellent Portability Excellent Bulky Complexity to operate Easy Compact size Small Large Technology Comparison List con’t. Factors to Consider FACTOR INJEX 1.0 ML. OTHER Delivers 1.0 ml dose properly Yes Marginal Multi orifice 1.0 ml. ampoule Yes No Prevents bolus injection Yes No Force exerted during injection Minimal Excessive Potential bruising or bleeding Minimal Excessive Pain during injection None to Min Medium Supplier’s financial strength Profitable Losses Drug efficacy and bioavailability Excellent Excellent Preserve of molecular integrity Excellent Excellent Injector Size Comparison Injex 50 – 2.7 Oz. 3.8” long Gas CO2 Type Injector – 1.5 lbs. 8.25” long CO2 Cartridge – 10 Shots Comparison of Propellant Advantages Injex Super Spring Highly consistent delivery Life of Super Spring10,000 injections No added costs or complexity No CO2 cartridges No inconveniences for patient Other Technology Gas CO2 Force Variable injection force First few shotsExcessive force Last few shotsInsufficient force Life of CO2 cartridge10 injections Added cost for CO2 cartridges Requires skill to change cartridges Frost & Sullivan Award - 2004 Award Recipient Injex-Equidyne Systems 2004 U.S. Emerging Injectable Drug Delivery Product Quality Leadership of the Year Award Thank you
