Merck Serono: New Presentation of Cyanokit(R) Approved in Europe

By Merck Serono, PRNE
Tuesday, October 12, 2010

New Presentation of Cyanide Antidote Cyanokit(R) in a Single Vial Facilitates Administration

GENEVA, October 13, 2010 - Merck Serono, a division of Merck KGaA, Darmstadt, Germany,
announced today that the new Cyanokit(R) 5 g presentation (hydroxocobalamin)
has been approved by the European Commission. 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 starting dose
of 5 g hydroxocobalamin in a single vial.

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.

"Immediate administration of an emergency treatment on the
scene of a fire within the first minutes after rescue is critical for the
survival of a smoke inhalation victim," said Dr. Bernhard Kirschbaum,
Executive Vice President Research and Development at Merck Serono. "By
simplifying the reconstitution and administration processes, we believe that
the new Cyanokit 5 g presentation represents a major improvement, allowing
for rapid management of cyanide poisoning, a vital asset particularly when
treating more than one victim."

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, 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 it is marketed by its partner Swedish Orphan

In the US, a Supplemental New Drug Application (sNDA) for the
new Cyanokit(R) presentation is currently under review by the Food and Drug
Administration (FDA).

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, 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.

About Merck Serono

Merck Serono is the division for innovative prescription
pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical
and chemical company. Headquartered in Geneva, Switzerland, Merck Serono
discovers, develops, manufactures and markets innovative small molecules and
biopharmaceuticals to help patients with unmet medical needs. In the United
and Canada, EMD Serono operates through separately incorporated

Merck Serono has leading brands serving patients with cancer (Erbitux(R),
cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility
(Gonal-f(R), follitropin alpha), endocrine and metabolic disorders (Saizen(R)
and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) 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 more than EUR 1 billion,
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 autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with
total revenues of EUR 7.7 billion in 2009, a history that began in 1668, and
a future shaped by approximately 40,000 (including Merck Millipore) employees
in 64 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 or

Media relations: Tel: +41-22-414-36-00

Biotechnology News

October 13 News

will not be displayed