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EMD Pharmaceuticals, Inc. Announces Submission Of New Drug Application For Cyanokit(R) For Treatment Of Cyanide Poisoning


6/20/2006 10:30:09 AM

DURHAM, N.C., June 20 /PRNewswire/ -- EMD Pharmaceuticals, Inc., a U.S. affiliate of Merck KGaA of Darmstadt, Germany, today announced the completed submission of a New Drug Application (NDA) for Cyanokit(R) (hydroxocobalamin) to the U.S. Food and Drug Administration (FDA). Cyanokit is in development for the treatment of known or suspected cyanide poisoning and is currently marketed in France by Merck KGaA affiliate Merck Sante. The FDA has previously granted Cyanokit Fast Track designation, which is intended to facilitate the development of new therapeutic medicines for the treatment of serious or life-threatening conditions with unmet medical needs.

A common and often unrecognized source of cyanide exposure occurs during a fire. Cyanide may be produced by the pyrolysis (incomplete burning) of common synthetic or plastic materials as well as from natural materials such as wood, paper and silk. Cyanide is increasingly recognized to be as common and dangerous as carbon monoxide as a fire smoke toxicant. Prompt recognition and treatment of cyanide poisoning with an antidote can save lives.

"As our first NDA filing, this submission marks an important milestone for both the product and our company," said Nancy J. Wysenski, President of EMD Pharmaceuticals. "With no new product approved to treat cyanide poisoning for several decades, this submission underscores our commitment to provide a new treatment for cyanide poisoning in the United States, especially one that would be available to treat smoke inhalation in a pre-hospital as well as a hospital setting."

The Cyanokit NDA filing includes data from animal and human studies that document the safety and efficacy of the product, including information from actual patient case studies of smoke-inhalation victims treated with Cyanokit in France for suspected cyanide poisoning.

Cyanokit has been used in France for 10 years in pre-hospital and hospital settings to treat cyanide poisoning resulting from smoke inhalation, ingestion and other causes. Although recognized in Europe for many years, only recently has the risk of cyanide exposure in fire smoke gained recognition in the U.S. The U.S. maintains one of the highest fire-related death rates of industrialized countries even though the number of fires has steadily decreased over the past two decades. Smoke inhalation is responsible for up to 80 percent of U.S. fire-related injuries and deaths. According to the United States Fire Administration (USFA), in 2004, the most recent year for which statistics are available:

-- 3,900 civilians and 117 firefighters lost their lives in fires, with an additional 17,785 civilians injured as the result of fire(1) -- Of all civilian fire-related deaths, 83 percent of them occurred in residences(2) -- An estimated 20,800 residential structure fires are attributed to mattresses, pillows, and bedding materials, all of which are highly likely to contain synthetic materials that release hydrogen cyanide when they smolder(3)

"Timing is critical when cyanide poisoning is suspected and having an antidote available at the scene of the incident can be the difference between life and death," said Keith L. Steward, MD, EMD's Vice President of Medical Affairs. "Cyanokit has many potential applications, including fires, industrial accidents or other incidents in which individuals have inhaled or ingested cyanide. In addition, Cyanokit could also be used to improve national preparedness for acts of chemical terrorism."

Cyanide is widely used in many U.S. industries. In 2004, the U.S. demand for hydrogen cyanide was projected at 1.838 billion pounds. Cyanide is primarily used as an intermediary in industrial processes that result in products used in building construction, transportation vehicle interiors, and in residential or commercial building interiors and furnishings. Man-made end- product sources may include nylon, rayon, polyvinyl chloride, modacrylic, polyurethane foam, polyester wadding, neoprene foam, rubber, plastics, Styrofoam, insulation and adhesive resins. Because it is readily available, cyanide also has the potential to be used as a terrorist weapon. Exposure to cyanides may occur via inhalation, ingestion or dermal contact. (4)

About Cyanokit

The active ingredient in Cyanokit, hydroxocobalamin, is a precursor of vitamin B12, and has been approved for marketing in France (marketed under the name Cyanokit(R), Merck Sante s.a.s.) since 1996 for the treatment of cyanide poisoning. Hydroxocobalamin works by binding directly to the cyanide, creating cyanocobalamin, a natural form of vitamin B12, which is excreted in the urine. The advantage of this approach is that methemoglobin is not produced and the oxygen-carrying capacity of the victim's blood is not lowered. Therefore, it is suitable for use in smoke inhalation victims. The most common side effect seen in clinical trials of hydroxocobalamin is injection site redness and temporary pink discoloration of the skin, urine and mucous membranes.

About EMD Pharmaceuticals, Inc.

A U.S. subsidiary of Merck KGaA of Darmstadt, Germany, EMD Pharmaceuticals is a specialty pharmaceutical company with a focus on clinical development, regulatory affairs, business development, sales and marketing in support of providing targeted therapies for cancer treatment and other specialty areas, including central nervous system disorders and cyanide poisoning. EMD is headquartered in Durham, N.C. Additional information about EMD is available at www.emdpharmaceuticals.com.

(1) National Fire Protection Association Fire Loss in the U.S. During 2004 Abridged Report and USFA's Firefighter Fatalities in the United States in 2004. (2) National Fire Protection Association Fire Loss in the U.S. During 2004 Abridged Report and USFA's Firefighter Fatalities in the United States in 2004. (3) U.S. Fire Administration Topical Fire Research Series: Mattress and Bedding Fires in Residential Structures; Vol. 2, Issue 17 (March 2002). (4) Agency for Toxic Substances and Disease Registry (ATSRD). ATSDR Toxicological Profile for Cyanide, September 2004 Update. National Institutes for Occupational Safety and Health (NIOSH), US Department of Health and Human Services, Public Health Service, Atlanta, GA (2004).

EMD Pharmaceuticals, Inc.

CONTACT: Lauren Tortorete of Biosector 2, +1-212-845-5609, orltortorete@biosector2.com


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