BRISTOL, TN – King Pharmaceuticals, Inc. (NYSE: KG) has been granted approval by the U.S. Food and Drug Administration (FDA) to market Duodote(tm) (atropine and pralidoxime chloride injection) to emergency medical services (EMS) personnel as a treatment for chemical nerve agent and insecticide poisoning.
Duodote(tm) is a single, dual-chambered auto-injector containing two separate drug products, atropine and pralidoxime chloride. Duodote(tm) is intended for administration in the event of chemical nerve agent and insecticide poisoning. The auto-injector is a pre-filled, ready-to-use unit designed to treat symptoms caused by chemical nerve agents, and organophosphorous insecticides. Duodote(tm) replaces the Mark I(tm) Nerve Agent Auto-Injector Kit that contains two separate auto-injectors (two separate injections) – one containing atropine and one containing pralidoxime chloride. The Mark I(tm) currently is used by the U.S. Department of Defense and allied nations, as well as EMS personnel in the U.S. “In these uncertain times it makes sense for EMS personnel to have the necessary tools to protect themselves and victims from potential nerve agent attacks,” said Dr. David Prezant, chief medical officer, FDNY-EMS Office of Medical Affairs. “The FDA’s decision allows us to provide atropine and pralidoxime chloride as a single injectable to EMS personnel to prepare for this threat.” Approved by the FDA, King’s chemical nerve agent antidote auto-injectors have been supplied to the U.S. Department of Defense and allied nations since the 1950s, and to emergency responders in the U.S. since 1995. Additionally, King has distributed a number of drug formulations, in its proprietary auto-injectors, to more than 30 countries for the emergency treatment of the victims of a chemical nerve agent poisoning. With marketing approval secured, King plans to launch Duodote(tm) in the fourth quarter, with product available in the first quarter of 2007. About Duodote(tm) Duodote(tm) is a single, pre-filled, dual-chambered auto-injector containing two separate chemical nerve agent antidotes widely known and trusted by the medical community and clinically accepted worldwide – atropine and pralidoxime chloride. Duodote(tm) is designed for the quick administration of a precise dose of atropine and pralidoxime chloride to treat symptoms of chemical nerve agent poisonings, such as with soman, tabun, sarin and VX, as well as toxic levels of common organophosphorous insecticides. When an individual is poisoned by a chemical nerve agent, the agent binds to enzymes in the body which cause neurotransmitters to over-stimulate nerves, muscles and glands. This results in an over-secretion of mucus in the respiratory tract and can eventually lead to suffocation due to the build-up of mucus. Atropine competes with the over-stimulating neurotransmitters, blocking the effects until normal function can return to the nerves, muscles and glands. In Duodote(tm), atropine is administered through the auto-injector first, immediately followed by the pralidoxime chloride. The pralidoxime chloride helps restore function of the nerves, muscles and glands. Duodote(tm) auto-injectors are designed to deliver medication through clothing and outer garments, including specialized personal protective ensembles worn by emergency responders. The auto-injector requires no preparation prior to use, and the technology is proven and reliable. For more information on Duodote(tm) please call (800) 638-8093 or send an inquiry to duodote@meridianmt.com. Fair Balance Statement The Duodote (atropine and pralidoxime chloride injection) Auto-Injector is indicated for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides. The Duodote Auto-Injector should be administered by Emergency Medical Services personnel who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication. The Duodote Auto-Injector is intended as an initial treatment of the symptoms of organophosphorous insecticide or nerve agent poisonings; definitive medical care should be sought immediately. Individuals should not rely solely upon agents such as atropine and pralidoxime to provide complete protection from chemical nerve agents and insecticide positioning. Primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective garments including masks designed specifically for this use. Evacuation and decontamination procedures should be undertaken as soon as possible. Medical Personnel assisting evacuated victims of nerve agent poisoning should avoid contaminating themselves by exposure to the victim’s clothing. In the presence of life-threatening poisoning by organophosphorous nerve agents or insecticides, there are no absolute contraindications to the use of the Duodote Auto-Injector. When symptoms of poisoning are not severe, Duodote Auto-Injector should be used with extreme caution in people with heart disease, arrhythmias, recent myocardial infarction, severe narrow angle glaucoma, pyloric stenosis, prostatic hypertrophy, significant renal insufficiency, chronic pulmonary disease, or hypersensitivity to any component of the product. PLEASE SEE ACCOMPANYING FULL PRESCRIBING INFORMATION. About King Pharmaceuticals King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management. For more information:Executive OfficeKing Pharmaceuticals, Inc.501 Fifth StreetBristol, TN 37620Investor Contacts: James E. GreenExecutive Vice President, Corporate Affairs Phone: (423) 989-8125 David E. RobinsonSenior Director, Corporate Affairs Phone: (423) 989-7045 Media Contact: Shannon CaudillPorter Novelli Public RelationsPhone: (312) 856-8892 Email: shannon.caudill@porternovelli.com
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