Merck Serono: New Presentation of Cyanokit(R) Approved by U.S. FDA

GENEVA, April 29, 2011 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that a new presentation of Cyanokit(R) 5 g (hydroxocobalamin) has been approved by the U.S. Food and Drug Administration (FDA). In the US, Cyanokit(R) is currently available in a kit comprising two 2.5 g vials as the starting dose that totals 5 g hydroxocobalamin. The new presentation contains the initial antidote dose of 5 g hydroxocobalamin in a single vial.

"The survival of a smoke inhalation victim with cyanide poisoning is highly related to the speed at which he/she receives the antidote", said Dr. Bernhard Kirschbaum, Executive Vice President Global Research and Development at Merck Serono. "As the initial dose required in the adult treatment is 5 g, we believe that emergency healthcare professionals will gain a significant amount of time to treat people who need immediate care, particularly when treating more than one patient."

Cyanokit(R) is indicated for the treatment of known or suspected cyanide poisoning. The drug is typically administered by fire and rescue crews at an emergency scene or in a hospital emergency room. It must be administered in conjunction with appropriate decontamination and supportive measures.

Cyanide poisoning commonly results from exposure to smoke produced from burning synthetic substances or natural materials such as cotton or paper in a closed environment. Additional causes may include accidental or intentional ingestion or exposure during industrial accidents or a terrorist attack involving cyanide.

In Europe, Cyanokit(R) is marketed by Merck Serono, with the exception of the Netherlands, Ireland, the United Kingdom and the Nordic and Baltic countries where the product is marketed by its partner Swedish Orphan Biovitrum. The new Cyanokit(R) 5 g presentation was approved in October 2010 by the European Medicines Agency (EMA).

In the US, Cyanokit(R) is commercialized through Merck Serono's partner Meridian Medical Technologies, Inc. that belongs to Pfizer Inc. The launch of Cyanokit(R) 5 g is planned towards end of 2011.

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. In the United States and Canada, EMD Serono operates as a separately incorporated affiliate of Merck Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility (Gonal-f(R), follitropin alfa), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride), (Egrifta(TM), tesamorelin), as well as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R), bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of over EUR 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in rheumatology.

For more information, please visit http://www.merckserono.com or http://www.merck.de

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 9.3 billion in 2010, a history that began in 1668, and a future shaped by more than 40,000 employees in 67 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.com or http://www.merck.de.

About Cyanokit(R)

The active ingredient in Cyanokit(R), hydroxocobalamin, is a precursor of vitamin B12. Hydroxocobalamin works by binding directly to the cyanide ions, creating cyanocobalamin, a natural form of vitamin B12, which is excreted in the urine.

Advantages of this approach are that methemoglobin is not produced and the oxygen-carrying capacity of the victim's blood is not lowered. Therefore, Cyanokit(R) is suitable for use in smoke inhalation victims. The most common adverse reactions seen in clinical trials of hydroxocobalamin with human subjects are transient and include: reddish discoloration of the skin, mucous membranes and urine, rash, increased blood pressure, nausea, vomiting, diarrhea, headache, and decreased white blood cell count and injection site reactions. Allergic reactions have been observed. Usage may interfere with some clinical laboratory evaluations.

The starting dose of Cyanokit(R) for adults is 5 g, administered by intravenous infusion. 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 10 g.

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