Transcript Presentation

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
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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
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Meridian’s Business Groups
• Pharmaceutical Systems
– Government Systems
• Military and Homeland Security
– Auto-Injectors
– Drug formulation development
– Specialty Pharmaceuticals
• EpiPen
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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
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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
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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)
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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
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Chemical Warfare Agents (continued)
• Depending on exposure, symptoms include:
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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
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Meridian’s Medical Readiness
Support
• Pre-stocking of auto-injector components
• Pre-stocking of medications
• Scheduled product delivery
• Maintaining a constant
production base
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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
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Medications in Meridian’s AutoInjector Delivery Systems
• Atropine
• Pralidoxime chloride
• Obidoxime chloride and atropine
sulphate
• Diazepam
• Morphine
• Avisafone, atropine sulphate, pralidoxime methane
sulphonate
• HI-6
• Other injectable medications possible
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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
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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
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New Product Introduction:
Multichambered Auto-injector
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A two chambered auto-injector
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Nose pressure activated
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Delivers the solutions sequentially through a single
needle
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A choice of oxime in the rear chamber will be available
along with atropine in the front chamber
– Pralidoxime chloride
– Obidoxime chloride
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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
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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
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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
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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)
– Pyridostigmine pre-treatment
• Germany
– 1 ATOXTM ComboPen (atropine sulphate /obidoxime chloride)
– 2 Atropens (atropine)
– 1 Morphine auto-injector
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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)
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Features of Auto-Injector Systems
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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
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INTERNATIONAL CUSTOMER BASE
[examples]
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Argentina
Australia
Belgium
Canada
Chile
Czech Republic
Finland
Germany
Greece
Hong Kong
Italy
Japan
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Kuwait
New Zealand
Norway
Portugal
Singapore
Slovak Republic
South Africa
Spain
UAE
UK MoD and MoH
USA