Merck Serono's Cyanokit(R) Recommended for European Approval
09/24/07 - PRNewswire
GENEVA, Switzerland, September 24 /PRNewswire/ --
- CHMP Issued Positive Opinion Recommending Marketing Authorization of
Cyanokit(R) for the Treatment of Known or Suspected Cyanide Poisoning
Merck Serono, a division of Merck KGaA, announced today that
the Committee for Medicinal Products for Human Use (CHMP), the scientific
committee of the European Medicines Agency (EMEA), issued a positive opinion
for its product Cyanokit(R) (active substance: hydroxocobalamin) for the
treatment of known or suspected cyanide poisoning. With this positive
opinion, the CHMP recommends the marketing authorization of Cyanokit(R) by
the European Commission.
Cyanokit(R)'s unique mechanism of action is based on its
ability to tightly bind cyanide ions. It may be used either in a pre-hospital
or hospital setting. It is to be administered together with appropriate
decontamination and supportive measures. Cyanide poisoning is primarily
caused by smoke inhalation during closed space structural fires. Additional
causes may include accidental or intentional ingestion or dermal exposure
during industrial accidents or a terrorist attack involving cyanide.
"We are very pleased with the CHMP's positive opinion
recommending the approval of Cyanokit(R)," said Roberto Gradnik, Head of
Merck Serono's Operations for Europe. "Treating cyanide poisoning as soon as
possible after exposure is critical to survival. Emergency health care
professionals will now have an effective product with a favorable safety
profile to treat people immediately for cyanide poisoning at the scene of a
fire, an accident or other emergency as well as in hospital. The availability
of Cyanokit(R) throughout Europe will have an impact on the survival and
prevention of neurological sequels of those who are poisoned by cyanide."
The CHMP reviews drug applications for all 27 countries in the
European Union(1) as well as Iceland, Liechtenstein and Norway. The CHMP
recommendation will now be considered by the European Commission, which will
deliver its final decision on the granting of the marketing authorization.
Cyanokit(R) received the approval from the Food and Drug Administration
in the United States of America in December 2006. When approved by the
European Commission, Cyanokit(R) will be the first cyanide antidote that is
approved in Europe via the Centralised Procedure for the treatment of known
or suspected cyanide poisoning in both adults and children.
(1) Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, United Kingdom
About Merck Serono
Merck Serono, the new division for innovative small molecules
and biopharmaceuticals of Merck, was established following the acquisition of
Serono and the integration of its business with the former Merck Ethicals
division. Headquartered in Geneva, Switzerland, Merck Serono discovers,
develops, produces and commercializes innovative products to help patients
with diseases with unmet needs. Our North American business operates in the
United States and Canada under EMD Serono.
Merck Serono has leading brands serving patients with cancer
(Erbitux(R)), multiple sclerosis (Rebif(R)), infertility (Gonal-f(R)),
metabolic and cardiometabolic disorders (Glucophage(R), Concor(R), Saizen(R),
Serostim(R)), as well as psoriasis (Raptiva(R)). With an annual R&D
investment of EUR 1bn, we are committed to growing our business in
specialist-focused therapeutic areas such as Neurology and Oncology, as well
as new therapeutic areas potentially arising out of our research and
development in autoimmune and inflammatory diseases.
About Merck
Merck is a global pharmaceutical and chemical company with sales of EUR
6.3 billion in 2006, a history that began in 1668, and a future shaped by
35,091 employees in 62 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 http://www.merckserono.net or
http://www.merck.de