Eisai to Launch Botulinum Toxin Type B Neuromuscular-Blocking Agent Nerbloc(R)
intramuscular Injection 2500 Units in Japan
Tokyo, Mar 26, 2013 - (JCN Newswire) - Eisai Co., Ltd. announced today that it
will launch NerBloc(R) Intramuscular Injection 2500 Units (botulinum toxin type
B, "NerBloc"), a neuromuscular-blocking agent, in Japan on March 27
as a treatment for cervical dystonia.
Botulinum toxin type B is a protein produced by the anaerobic bacterium
Clostridium botulinum type B. By acting specifically on motor nerve terminals
at the neuromuscular junction, it inhibits the release of acetylcholine from
the cholinergic nerve endings and exhibits muscle relaxant effects. Eisai
acquired the exclusive rights to develop and market NerBloc in Japan from
U.S.-based Elan Pharmaceuticals, Inc. and Ireland-based Elan Pharma
International Ltd. (collectively, "Elan") in September 2000 and was
approved as the marketing authorization holder following product development.
NerBloc was then listed on the National Health Insurance (NHI) drug price list
on February 22, 2013.
In a double-blind, placebo-controlled trial (Study 131) conducted by Eisai in
Japan in patients with cervical dystonia, NerBloc showed statistically
significant improvement in TWSTRS (Toronto Western Spasmodic Torticollis Rating
Scale) total score from baseline to week four versus placebo. No serious side
effects were reported, with the most common adverse events being difficulty in
swallowing, dry mouth and thirst.
Cervical dystonia causes symptoms such as cephalic displacement, tremor,
scoliosis, and cervical pain as a result of abnormal cervical muscle
contraction. Symptoms normally appear during adolescence or adulthood,
progressing for anywhere between several months and several years before they
eventually reach a plateau. Cervical dystonia can be treated with botulinum
toxin therapy, oral medications such as anticholinergic agents and muscle
relaxants, or surgery. Most notably, botulinum toxin is listed in overseas
treatment guidelines as a safe and effective modality for the treatment of
cervical dystonia and is recommended as a first-line treatment option for the
Eisai obtained exclusive European marketing rights for the drug from
U.S.-based Solstice Neurosciences Inc., LLC (a wholly owned subsidiary of US
WorldMeds, LLC) who had previously assumed the rights to the drug from Elan,
and currently markets the drug in Europe under the brand name NeuroBloc(R). By
providing NerBloc as a new treatment option for cervical dystonia in Japan,
Eisai aims to make further contributions to patients. In accordance with
approval conditions, Eisai will conduct a post-marketing use results survey
(all-case surveillance) in all patients who are administered NerBloc until the
predetermined number of patients has been reached, in order to promote the
effective and safe use of the drug.
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care
(hhc) company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three therapeutic areas: integrative
neuroscience, including neurology and psychiatric medicines; integrative
oncology, which encompasses oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai actively
participates in all aspects of the worldwide healthcare system. For more
information about Eisai Co., Ltd., please visit www.eisai.com.
Public Relations Department,
Eisai Co., Ltd.
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