Merck Serono: New Presentation of Cyanokit(R) Approved by U.S. FDABy Merck Serono S A, PRNE
Thursday, April 28, 2011
New Presentation of Cyanide Antidote Cyanokit(R) 5 g in a Single Vial Matches the Antidote Initial Dose
GENEVA, April 29, 2011 - 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
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
For more information, please visit www.merckserono.com
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
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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Tags: April 29, Geneva, Merck Serono S A, Switzerland, United States of America