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30 Apr 2008 |
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Merck Serono Announces Initiation of Phase II Clinical Trial of Atacicept in Relapsing Multiple Sclerosis |
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Geneva, Switzerland, April 30, 2008 – Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and its partner ZymoGenetics, Inc. (NASDAQ: ZGEN) today announced the initiation of a Phase II clinical trial to evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis (RMS).
“This trial with atacicept underlines Merck Serono’s long-term commitment to patients with multiple sclerosis,” said Dr. Anton Hoos, Head of Global Development at Merck Serono. “Atacicept has the potential to complement existing MS drugs by offering a novel mode of action and convenient administration.”
“Patients with multiple sclerosis need more treatment options,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “Our preclinical models have shown biological activity of atacicept in multiple sclerosis and, because of the growing body of supporting data in the literature indicating the importance of B cells and antibodies in the pathology of multiple sclerosis, we believe there is strong rationale for the clinical testing of atacicept in patients with RMS.”
The four-arm randomized, double-blind, placebo-controlled, multicenter study will evaluate the safety and efficacy of atacicept in patients with RMS over 36 weeks of treatment. The primary objective of the study is to evaluate the efficacy of atacicept in reducing central nervous system inflammation in subjects with RMS as assessed by frequent MRI measures.
Approximately 300 RMS patients meeting the eligibility criteria will be randomly assigned to receive one of three subcutaneous doses of atacicept or placebo for 36 weeks. Patients will be followed up until week 48.
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16 Apr 2008 |
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Merck Announces Planned Investment of $50 million in Research Center in the US |
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Geneva, Switzerland, April 16, 2008 – Merck Serono and its US affiliate EMD Serono, Inc., announced today a planned expansion of EMD Serono’s US presence with an anticipated investment of $50 million at its Billerica facility northwest of Boston, Massachusetts. The company anticipates that this investment will create more than 100 new jobs in Massachusetts.
The investment will support the construction of a center of excellence in discovery, creating critical mass in research with a common goal of finding new treatments for unmet medical needs.
Once complete, the new site will accommodate approximately 200 scientists with expertise in cancer biology, cancer immunotherapy, oncogene signaling, manufacturing cell lines, medicinal chemistry, molecular modeling, protein engineering, and therapeutic antibodies, across the research areas of cancer and fertility, as well as approximately 50 employees in Technical Operations who specialize in process development and protein production.
The company’s protein production facility in Billerica, which manufactures products for early stage clinical testing, is a significant reason why the site was selected for expansion; the close proximity of protein production to research drives collaborative interactions and supports the rapid transition from research to manufacturing.
Construction at the new site will begin early next year and is expected to be complete in 2010. Upon completion, the total square footage of the Billerica Campus will be approximately 64,000 square meters, including more than 48,800 square meters of lab space.
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19 Mar 2008 |
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Merck Serono Launches Cyanokit® in Japan |
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Cyanokit® is an antidote for the treatment of known or suspected cyanide poisoning
Geneva, Switzerland, March 19, 2008 – Merck Serono 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.
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