King Pharmaceuticals Licenses Exclusive Rights to CYANOKIT in United States

BRISTOL, Tenn. – King Pharmaceuticals, Inc. (NYSE:KG) announced today that it has licensed from Merck Santé S.A.S., an affiliate of Merck KGaA, Darmstadt, Germany, the exclusive rights to market and sell CYANOKIT® 5 g (hydroxocobalamin for injection) ANTIDOTE in the U.S. CYANOKIT® is indicated for the treatment of known or suspected cyanide poisoning, typically caused by smoke inhalation from fires.

"CYANOKIT® is well-suited to King’s existing line of acute care products,” said Brian A. Markison, Chairman, President and CEO. “Our portfolio of antidotes currently serves the emergency medical services community, as well as the U.S. Department of Defense and other federal, state and local agencies. The addition of CYANOKIT® to this portfolio is a natural fit, as we are uniquely positioned to market this antidote in both pre-hospital and hospital settings.”

CYANOKIT® will be sold and distributed through Meridian Medical Technologies, Inc., a wholly owned subsidiary of King.

Cyanide is a chemical that can exist as a colorless gas or as white powder or crystals. Cyanide exposure/poisoning potentially can occur through the following sources: smoke inhalation from structure fires, when products containing carbon and nitrogen burn, such as wool, paper, cotton, silk and plastics; exposure to industrial processes that result in products used in building construction, transportation vehicle interiors, and in residential or commercial building interiors and furnishings; and in the event of a terrorist attack. Smoke inhalation from building fires is the most common source of cyanide poisoning.1

CYANOKIT® is the only emergency antidote indicated for both known and suspected cyanide poisoning. The active ingredient is hydroxocobalamin, which forms a strong bond with cyanide, converting it to vitamin B12, which can then be safely excreted from the body. It is designed specifically to be used on the scene or at the hospital for acute cyanide poisoning, or suspected poisoning, from any source.

“Whether the result of a structure fire or terrorist act, cyanide poisoning is a life-threatening matter that requires immediate medical attention,” said Dr. Joe Nelson, State EMS Medical Director for Florida, which stocks CYANOKIT® in emergency medical service and fire vehicles. “The ability to treat victims of known or suspected cyanide poisoning at the scene helps protect first responders and citizens and can save lives.”

About CYANOKIT® CYANOKIT® is a cyanide poisoning antidote. CYANOKIT® is administered intravenously after being reconstituted with sodium chloride for injection. Hydroxocobalamin, the main component in CYANOKIT®, strongly binds the cyanide directly, forming a natural form of vitamin B12, cyanocobalamin, which is excreted in the urine.2 The initial dose of CYANOKIT® for adults is 5 g, administered by intravenous infusion over 15 minutes. Depending upon the severity of the poisoning and the clinical response, a second dose of 5 g may be administered up to a total dose of 10g.

CYANOKIT® is packaged as two 2.5 g vials of lyophilized (freeze-dried) hydroxocobalamin along with two sterile transfer spikes, one intravenous administration set, user instructions and a package insert. After rapid reconstitution with 100 ml of sodium chloride for injection (not included in kit), each vial can be immediately administered.2

CYANOKIT® was approved by the U.S. Food and Drug Administration in 2006. It has been proven generally safe and well-tolerated, even in suspected cases.

Cyanide poisoning may occur through inhalation, ingestion, dermal exposure or parenteral administration.3 The inhalation route results in the most rapid effect in the body. When hydrogen cyanide is inhaled, it quickly enters the bloodstream through the lungs and rapidly enters cells where it deactivates an important enzyme in cell respiration, and prevents the cells from using oxygen. The brain and the heart are most vulnerable to the effects of cyanide poisoning because they are most dependent on oxygen to function properly.4 Therefore, the first symptoms of cyanide poisoning appear at the neurological and cardiovascular levels.3,5 Cyanide poisoning can be treated effectively if it is recognized promptly and if intervention is initiated immediately. In this context, it is important that pre-hospital providers recognize the signs and symptoms of cyanide poisoning and have smoke inhalation evaluation and treatment protocols in place.5

Indication CYANOKIT® Antidote is indicated for the treatment of known or suspected cyanide poisoning. If clinical suspicion of cyanide poisoning is high, CYANOKIT® Antidote should be administered without delay.

Important Safety Information Prior to administration of CYANOKIT® Antidote, smoke-inhalation victims should be assessed for: exposure to fire or smoke in an enclosed area; presence of soot around the mouth, nose or oropharynx; altered mental status. Use caution in the management of patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin. Allergic reactions may include: anaphylaxis, chest tightness, edema, urticaria, pruritus, dyspnea, and rash. Most common adverse reactions (>5%) are transient and include chromaturia (red-colored urine), erythema (skin redness), rash, increased blood pressure, nausea, headache, decreased lymphocyte percent, and injection site reactions. Usage may interfere with some clinical laboratory evaluations. If the decision is made to administer another antidote with CYANOKIT®, these drugs should not be administered in the same IV line. The safety of simultaneous administration has not been established.

Please see www.CYANOKIT.com for full Prescribing Information.

About King Pharmaceuticals King, headquartered in Bristol, Tenn., 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 and technologies that compliment the Company’s focus in specialty-driven markets, particularly the neuroscience and hospital markets. King’s wholly–owned subsidiary, Alpharma, Inc., is also a leader in development, registration, manufacture and the marketing of pharmaceutical products for food producing animals.

King is the leading manufacturer of acute-care products for the self-administration of injectable drugs, including DuoDote™ Auto-Injector in the U.S., which is indicated for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides, and EpiPen®, which is indicated for emergency treatment of allergic reactions (anaphylaxis) for people with a history of an anaphylactic reaction.

  1. Walsh DW, O’Brien DJ, Arnold JL. Cyanide poisoning: not just a HAZMAT issue. http://fe.pennnet.com/Articles/Article_Display.cfm?Section=OnlineArticles&ARTICLE_ID=212520&VERSION_NUM=1&p=71. Accessed June 22, 2009.
  2. CYANOKIT® Prescribing Information. Napa, CA: Dey, LP; 2006.
  3. Holstege CP, Isom, GE, Kirk, MA. Cyanide and hydrogen sulfide. In: Flomenbaum NE, Goldfrank LR, Hoffman RS, Howland MA, Lewin NA, Nelson LS, eds. Goldfrank's Toxicologic Emergencies. 8th ed. New York, NY: McGraw-Hill; 2006:1712-1757.
  4. Borron SW. Recognition and treatment of acute cyanide poisoning. J Emerg Nurs. 2006;32:S12-S18.
  5. Walsh DW, O’Brien DJ, Augustine J. Cyanide Exposure, Smoke Inhalation and Pre-Hospital Treatment: Recognizing the Signs and Symptoms and Available Treatment Options. http://www.firesmoke.org/index.php?option=com_content&view=article&id=166&Itemid=142. Accessed September 18, 2009.

Florida Bureau of EMS does not endorse products or services. This information is provided as a courtesy to the EMS community and interested parties.

CYANOKIT Antidote is a registered trademark of Merck Santé S.A.S., licensed by Meridian Medical Technologies, Inc., a wholly owned subsidiary of King Pharmaceuticals, Inc.

DuoDote Auto-Injector is a trademark of Meridian Medical Technologies, Inc., a wholly owned subsidiary of King Pharmaceuticals, Inc.

EpiPen is a registered trademark of Mylan, Inc. licensed exclusively to its wholly owned affiliate, Dey, L.P. of Napa, California, USA.

Copyright © 2009 Meridian Medical Technologies, Inc., a wholly owned subsidiary of King Pharmaceuticals, Inc.

For more information, contact: Jack Howarth Vice President, Investor Relations Phone: 908-429-8350

Media Contact: Shannon Caudill (Porter Novelli) Phone: 312-856-8892 Email: shannon.caudill@porternovelli.com