Protecting those who protect us Meridian Medical Technologies a King Pharmaceuticals, Inc. Company
Meridian Medical Technologies Meridian Medical Technologies, in business since 1958, was acquired on January 8, 2003 by King Pharmaceuticals, Inc. Headquarters located in Bristol, Tennessee
Meridian’s Manufacturing Facilities Missouri, USA Manufacture auto-injectors Meet current Good Manufacturing Practices Guidelines of the U.S. Food & Drug Administration Aseptic filling, drug formulation Meet United Kingdom’s MHRA guidelines Meet German BfArM guidelines
Meridian’s Business Groups Pharmaceutical Systems Government Systems Military and Homeland Security Auto-Injectors Drug formulation development Specialty Pharmaceuticals EpiPen
Meridian’s Experience Development and production of automatic injector products for military and first responders use in the defense against chemical warfare Ability to apply injector technology to non-military medical problems Supplied more than 175 million auto-injectors for emergency use
Meridian’s Capabilities Pharmaceutical development laboratory, product formulation, process development Cleaning and preparation capability for assembly in aseptic production environment Product formulation consistent with product processing requirements Clean room and product filling operations New Class100 filling suite for sterile product manufacturing
Chemical Agent Threat Many countries engage in production of nerve agents Most can deliver agents via ballistic missiles, aircraft, artillery, bombs More than 20 terrorist organizations exist worldwide Chemical terrorism against civilians became a reality in 1995 (Tokyo subway incident)
Chemical Warfare Agents Extremely potent organophosphorous compounds More widely know agents: tabun (GA), sarin (GB), soman (GD), GF and VX Colourless, odorless liquids Penetrate skin and normal clothing Can be absorbed through lungs
Chemical Warfare Agents (continued) Depending on exposure, symptoms include: Watering eyes, unexplained runny nose Pinpointed pupils of the eye resulting in blurred vision Tightness in chest, difficulty breathing Drooling, excessive sweating, nausea, vomiting and abdominal cramps Involuntary urination and defecation, jerking, twitching and staggering Headache, drowsiness, coma, convulsions, and stoppage of breathing Treat immediately with antidotes: Atropine followed by oxime
Meridian’s Medical Readiness Support Pre-stocking of auto-injector components Pre-stocking of medications Scheduled product delivery Maintaining a constant production base
Advantages of Meridian’s Services Experienced and reliable producer of drug delivery systems Stock filled only as needed Pre-planned manufacturing schedule Access to scarce medications
Medications in Meridian’s Auto-Injector Delivery Systems Atropine Pralidoxime chloride Obidoxime chloride and atropine sulphate Diazepam Morphine Avisafone, atropine sulphate, pralidoxime methane sulphonate HI-6 Other injectable medications possible
Meridian’s Auto-Injectors Auto-injectors are designed for use by military personnel under combat conditions for the self-administration of medication, and by civilian emergency response teams to treat mass casualties AtroPen® Delivers: 2mg atropine sulfate equivalent in 0.7mL Pralidoxime Chloride ComboPen® Delivers: 600mg pralidoxime chloride in 2mL ATOXTM ComboPen® Delivers: 220mg obidoxime chloride plus 2mg atropine sulfate in 2mL
Meridian’s Auto-Injectors Autoject ComboPen® Nerve Agent Antidote (L4A1) Delivers: 10 mg avisafone/ 2mg atropine sulfate/ 500 mg pralidoxime methane sulphonate in 2mL Diazepam Auto-Injector C-IV Delivers: 10mg diazepam in 2mL Morphine C-II Delivers: 10mg morphine sulfate in 1mL Trainers AtroPen Trainer, ComboPen Trainer
New Product Introduction: Multichambered Auto-injector A two chambered auto-injector Nose pressure activated Delivers the solutions sequentially through a single needle A choice of oxime in the rear chamber will be available along with atropine in the front chamber Pralidoxime chloride Obidoxime chloride
New Product Introduction: ATNAA Multichambered Auto-injector A two chambered auto-injector (ATNAA) [NSN 6505-01-362-7427] Delivers: 2mg atropine sulfate equivalent and 600 mg pralidoxime chloride in 2.2mL sequentially through a single needle Intended to replace the Mark I Nerve Agent Antidote Kit, [NAAK], (1 AtroPen + 1 ComboPen) Fielded by U.S. Armed Forces in 2003
In Development: ATOXTM Multichambered Auto-injector Under development for a NATO country Delivers: 2mg atropine sulfate equivalent and 200 mg obidoxime chloride in 2.2mL sequentially through a single needle Intended to provide an alternative to the ATOXTM ComboPen Marketing Authorization Application to be filed early 2004 with the regulatory agency
In Development: Wet / Dry Auto-injector Two chambered [wet and dry], single needle auto-injection system One step, dissolves HI-6 and atropine sulfate (2.0 mg) as it is injected Rear chamber contains 2.0 mg atropine sulfate in 2.4 mL and 500 mg HI-6 in front chamber for a single injection Delivers the solution intramuscular Nose end pressure activated Anticipated availability in 2005
Treatment Regimens per Soldier by Country United Kingdom 3 ComboPens (avisafone/ 2mg atropine sulfate/ 500 mg pralidoxime methane sulphonate) 1 Morphine auto-injector Pyridostigmine pre-treatment USA 3 Atropens (atropine sulphate equivalent) 3 ComboPens (pralidoxime chloride) Germany 1 ATOXTM ComboPen (atropine sulphate /obidoxime chloride) 2 Atropens (atropine)
Treatment Regimens per Soldier by Country Canada 3 Atropine/HI-6 auto-injectors 1 Morphine auto-injector Netherlands, Belgium, Italy, Norway, Greece, Turkey, Czech Republic, Slovak Republic 3 ATOXTM ComboPens (atropine sulphate /obidoxime chloride)
Features of Auto-Injector Systems Individual self injections Improved effectiveness Prefilled dosage Deep Intramuscular injections through clothing Pressure activated Safe for non-medical personnel Sterile, small, light-weight Ease of administration Trainers available
Country Profile: Example of Treatment Requirement Total Armed Forces (active). . . . 55,000 Recommended regime. . . . . . . . atropine/obidoxime Recommended auto-injector treatment . . . . . . . . . . . . . . . . . . 3 per soldier Shelf-life of auto-injector. . . . . . . 5 years from manufacture date Production batch size . . . . . . . . . 25,000 Total auto-injector requirement (55,000 x 3). . . . . . . . . . . . . . . . . 165,000
INTERNATIONAL CUSTOMER BASE [examples] Argentina Australia Belgium Canada Chile Czech Republic Finland Germany Greece Hong Kong Italy Japan Kuwait New Zealand Norway Portugal Singapore Slovak Republic South Africa Spain UAE UK MoD and MoH USA