Healthcare Industry News:  neurodegenerative 

Biopharmaceuticals

 News Release - March 19, 2008

Merck Serono Launches Cyanokit(R) in Japan

Cyanokit(R) is an Antidote for the Treatment of Known or Suspected Cyanide Poisoning

GENEVA, March 19 (HSMN NewsFeed) -- Merck Serono, a division of Merck KGaA of Darmstadt, Germany, announced today that Cyanokit® (active substance: hydroxocobalamin) is commercially available in Japan as of March 18, 2008, through its local affiliate Merck Serono Co., Ltd. Cyanokit® was approved by the Japanese Ministry of Health in November 2007, for the treatment of cyanide intoxication caused by hydrocyanic acid and its derivatives in both adults and the pediatric population. Cyanokit® will be mainly distributed to hospitals and healthcare emergency services.

"The availability of Cyanokit® is a key milestone for emergency healthcare professionals in Japan as they can now rely on an effective product, with an excellent safety profile, to treat people who need immediate, life-saving care," said Franck Latrille, Head of Merck Serono's International Operations. "We believe that Cyanokit® will make a difference on the survival and prevention of irreversible neurological injury of those who have been poisoned, even heavily, by cyanide."

Cyanide poisoning is primarily caused by smoke inhalation during closed-space structural fires. Additional causes may include accidental or intentional ingestion, inhalation, dermal exposure during industrial accidents or a terrorist attack involving cyanide.

The unique mechanism of action of Cyanokit® is based on its ability to tightly bind cyanide ions. It may be used in a hospital setting or on-site at an emergency situation. Cyanokit® is to be administered in conjunction with appropriate decontamination and supportive measures.

The most common side effects associated with Cyanokit® are red coloration of the skin, mucous membranes and urine, all of which are reversible.

Cyanokit® is also commercially available in the United States of America and has recently been approved in the European Union.

About Cyanokit®

The active ingredient in Cyanokit®, hydroxocobalamin, is a precursor of vitamin B12. Hydroxocobalamin works by binding directly to the cyanide ions, creating cyanocobalamin, a natural form of vitamin B12, a stable, non-toxic compound that 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® 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 initial dose of Cyanokit® 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. In pediatric patients, the initial dose of Cyanokit® is 70 mg/kg body weight not exceeding 5 g and the subsequent dose is 70 mg/kg body weight not exceeding 5 g.

About Merck Serono Co., Ltd

Merck Serono Co., Ltd. is the Japanese arm of Merck Serono (Headquarters: Geneva, Switzerland) which was established in January 2007 as Merck's division specializing in prescription medicine following the acquisition of Serono S.A. by Merck. Merck Serono launched operations in Japan on October 1, 2007 with a focus on two areas of therapeutic strength, oncology and fertility.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).

With an annual R&D investment of around 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 autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.1 billion in 2007, a history that began in 1668, and a future shaped by 30,968 employees in 60 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


Source: Merck Serono International

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