DURHAM, N.C., June 20
EMD Pharmaceuticals, Inc., a U.S.affiliate of Merck KGaA of Darmstadt, Germany , today announced the completedsubmission of a New Drug Application (NDA) for Cyanokit(R) (hydroxocobalamin)to the U.S. Food and Drug Administration (FDA). Cyanokit is in developmentfor the treatment of known or suspected cyanide poisoning and is currentlymarketed in France by Merck KGaA affiliate Merck Sante. The FDA haspreviously granted Cyanokit Fast Track designation, which is intended tofacilitate the development of new therapeutic medicines for the treatment ofserious or life-threatening conditions with unmet medical needs.
A common and often unrecognized source of cyanide exposure occurs during afire. Cyanide may be produced by the pyrolysis (incomplete burning) of commonsynthetic or plastic materials as well as from natural materials such as wood,paper and silk. Cyanide is increasingly recognized to be as common anddangerous as carbon monoxide as a fire smoke toxicant. Prompt recognition andtreatment of cyanide poisoning with an antidote can save lives.
"As our first NDA filing, this submission marks an important milestone forboth the product and our company," said Nancy J. Wysenski, President of EMDPharmaceuticals. "With no new product approved to treat cyanide poisoning forseveral decades, this submission underscores our commitment to provide a newtreatment for cyanide poisoning in the United States , especially one thatwould be available to treat smoke inhalation in a pre-hospital as well as ahospital setting."
The Cyanokit NDA filing includes data from animal and human studies thatdocument the safety and efficacy of the product, including information fromactual patient case studies of smoke-inhalation victims treated with Cyanokitin France for suspected cyanide poisoning.
Cyanokit has been used in France for 10 years in pre-hospital and hospitalsettings to treat cyanide poisoning resulting from smoke inhalation, ingestionand other causes. Although recognized in Europe for many years, only recentlyhas 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 ofindustrialized countries even though the number of fires has steadilydecreased over the past two decades. Smoke inhalation is responsible for upto 80 percent of U.S. fire-related injuries and deaths. According to the United States Fire Administration (USFA), in 2004, the most recent year forwhich 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 anantidote available at the scene of the incident can be the difference betweenlife and death," said Keith L. Steward, MD, EMD's Vice President of MedicalAffairs. "Cyanokit has many potential applications, including fires,industrial accidents or other incidents in which individuals have inhaled oringested cyanide. In addition, Cyanokit could also be used to improvenational preparedness for acts of chemical terrorism."
Cyanide is widely used in many U.S. industries. In 2004, the U.S. demandfor hydrogen cyanide was projected at 1.838 billion pounds. Cyanide isprimarily used as an intermediary in industrial processes that result inproducts used in building construction, transportation vehicle interiors, andin 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 tocyanides may occur via inhalation, ingestion or dermal contact. (4)
About Cyanokit
The active ingredient in Cyanokit, hydroxocobalamin, is a precursor ofvitamin B12, and has been approved for marketing in France (marketed under thename Cyanokit(R), Merck Sante s.a.s.) since 1996 for the treatment of cyanidepoisoning. Hydroxocobalamin works by binding directly to the cyanide, creatingcyanocobalamin, a natural form of vitamin B12, which is excreted in the urine.The advantage of this approach is that methemoglobin is not produced and theoxygen-carrying capacity of the victim's blood is not lowered. Therefore, itis suitable for use in smoke inhalation victims. The most common side effectseen in clinical trials of hydroxocobalamin is injection site redness andtemporary pink discoloration of the skin, urine and mucous membranes.
About EMD Pharmaceuticals, Inc.
A U.S. subsidiary of Merck KGaA of Darmstadt, Germany , EMD Pharmaceuticalsis a specialty pharmaceutical company with a focus on clinical development,regulatory affairs, business development, sales and marketing in support ofproviding targeted therapies for cancer treatment and other specialty areas,including central nervous system disorders and cyanide poisoning. EMD isheadquartered in Durham, N.C. Additional information about EMD is availableat 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).SOURCE EMD Pharmaceuticals, Inc.
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