Protecting those who protect us Meridian Medical Technologies

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 2

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 Bf. Ar. M guidelines 3

Meridian’s Business Groups • Pharmaceutical Systems – Government Systems • Military and Homeland Security – Auto-Injectors – Drug formulation development – Specialty Pharmaceuticals • Epi. Pen 4

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 5

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 Class 100 filling suite for sterile product manufacturing 6

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) 7

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 8

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 9

Meridian’s Medical Readiness Support • Pre-stocking of auto-injector components • Pre-stocking of medications • Scheduled product delivery • Maintaining a constant production base 10

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 11

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 12

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 • Atro. Pen® – Delivers: 2 mg atropine sulfate equivalent in 0. 7 m. L • Pralidoxime Chloride Combo. Pen® – Delivers: 600 mg pralidoxime chloride in 2 m. L • ATOXTM Combo. Pen® – Delivers: 220 mg obidoxime chloride plus 2 mg atropine sulfate in 2 m. L 13

Meridian’s Auto-Injectors • Autoject Combo. Pen® Nerve Agent Antidote (L 4 A 1) – Delivers: 10 mg avisafone/ 2 mg atropine sulfate/ 500 mg pralidoxime methane sulphonate in 2 m. L • Diazepam Auto-Injector C-IV – Delivers: 10 mg diazepam in 2 m. L • Morphine C-II – Delivers: 10 mg morphine sulfate in 1 m. L • Trainers – Atro. Pen Trainer, Combo. Pen Trainer 14

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 15

New Product Introduction: ATNAA Multichambered Auto-injector • A two chambered auto-injector (ATNAA) [NSN 6505 -01 -362 -7427] • Delivers: 2 mg atropine sulfate equivalent and 600 mg pralidoxime chloride in 2. 2 m. L sequentially through a single needle • Intended to replace the Mark I Nerve Agent Antidote Kit, [NAAK], (1 Atro. Pen + 1 Combo. Pen) • Fielded by U. S. Armed Forces in 2003 16

In Development: ATOXTM Multichambered Auto-injector • Under development for a NATO country • Delivers: 2 mg atropine sulfate equivalent and 200 mg obidoxime chloride in 2. 2 m. L sequentially through a single needle • Intended to provide an alternative to the ATOXTM Combo. Pen • Marketing Authorization Application to be filed early 2004 with the regulatory agency 17

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 m. L and 500 mg HI-6 in front chamber for a single injection • Delivers the solution intramuscular • Nose end pressure activated • Anticipated availability in 2005 18

Treatment Regimens per Soldier by Country • United Kingdom – 3 Combo. Pens (avisafone/ 2 mg atropine sulfate/ 500 mg pralidoxime methane sulphonate) – 1 Morphine auto-injector – Pyridostigmine pre-treatment • USA – 3 Atropens (atropine sulphate equivalent) – 3 Combo. Pens (pralidoxime chloride) – Pyridostigmine pre-treatment • Germany – 1 ATOXTM Combo. Pen (atropine sulphate /obidoxime chloride) – 2 Atropens (atropine) – 1 Morphine auto-injector 19

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 Combo. Pens (atropine sulphate /obidoxime chloride) 20

Features of Auto-Injector Systems • • • 21 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). . • Recommended regime. . . . atropine/obidoxime • Recommended auto-injector treatment. . . . • Shelf-life of auto-injector. . . . 55, 000 3 per soldier 5 years from manufacture date • Production batch size. . • Total auto-injector requirement (55, 000 x 3). . . . 22 25, 000 165, 000

INTERNATIONAL CUSTOMER BASE [examples] • • • 23 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 Mo. D and Mo. H USA