Eisai Recieves Manufacturing and Marketing Authorization for Ant

Eisai Recieves Manufacturing and Marketing Authorization for Antiepileptic Agent
Inovelon(R) in Japan 
Tokyo, Mar 25, 2013 - (JCN Newswire) -  Eisai Co., Ltd. announced today that it
has received manufacturing and marketing authorization in Japan from the
Japanese Ministry of Health, Labour and Welfare (MHLW) for antiepileptic agent
Inovelon(R) (rufinamide), approving the drug as an adjunctive therapy to other
antiepileptic drugs (AEDs) in the treatment of Lennox-Gastaut syndrome (LGS), a
rare disorder. 
Rufinamide was designated by the MHLW's "Study Group on Unapproved
Drugs," the predecessor to the "Study Group on Unapproved and
Off-Label Drugs of High Medical Need," in October 2009 as an unapproved
drug for which development support would be provided. Following clinical
development studies of rufinamide in Japan, Eisai later submitted a
manufacturing and marketing authorization application for the drug to the MHLW
in August 2012. Rufinamide has been designated as an orphan drug in Japan since
June 2011. 
LGS is one of the most severe and intractable forms of childhood-onset
epilepsy. Characterized by multiple seizure types, the disorder is extremely
difficult to control, with patients normally having to take several different
AEDs. LGS also often leads to delayed intellectual development, behavioral
disturbances, and frequent falls due to sudden loss of consciousness, and
therefore has a significant impact on the quality of life of both patients and
their families. 
Eisai defines epilepsy as a therapeutic area of focus and has been marketing
rufinamide in Europe and the United States since acquiring marketing approval
for the drug in January 2007 and November 2008, respectively. By obtaining
marketing authorization for the drug in Japan, Eisai seeks to make further
contributions to address the diverse needs of, and increase the benefits
provided to, patients with LGS and their families as well as medical
professionals. 
About Lennox-Gastaut Syndrome (LGS) 
One of the most rare and severe forms of epilepsy, LGS usually develops in
preschool-aged children, many of whom have some kind of preexisting organic
brain disorder, such as encephalopathy. LGS is not only characterized by
frequent seizures and multiple seizure types, it is also accompanied by delayed
intellectual development and personality disorders. The majority of patients
with LGS experience tonic (muscle stiffening), atonic (sudden loss of muscle
tone or drop attacks) and absence (brief loss of consciousness or staring)
seizures. Tonic-clonic (grand mal), myoclonic (sudden muscle jerks) and other
types of seizures may also occur. Tonic and atonic seizures lead to the sudden
falls seen in LGS patients that are known as "drop attacks," a
primary cause of injury. Patients with LGS often wear protective helmets with
face guards to protect against head injury from these attacks. Although LGS is
most commonly treated with antiepileptic drugs, patients whose seizures are
difficult to manage with pharmacotherapy may have to undergo surgical
treatment. 
About Rufinamide 
Rufinamide is a triazole derivative that is structurally unrelated to
currently marketed antiepileptic drugs (AEDs). The agent is believed to exert
its antiepileptic effects by regulating activity of sodium channels in the
brain that carry excessive electrical charges thought to cause seizures, so as
to prolong their inactive state. Eisai entered into a license agreement with
Novartis Pharma AG in February 2004, under which Novartis granted Eisai the
exclusive worldwide rights to develop, use, manufacture and market rufinamide
for any human therapeutic use excluding bipolar mood disorder, anxiety
disorders and ophthalmologic disorders. The agent received approval in the
European Union in January 2007 and in the United States in November 2008 as an
adjunctive therapy to other AEDs in the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS). Rufinamide is currently marketed in these
regions under the brand names Inovelon(R) and Banzel(R), respectively, in
addition to the Asia region. 
Clinical Study in Japan 
A 12-week double-blind comparative study of rufinamide versus placebo as
adjunctive therapy to other antiepileptic drugs was conducted in 59 patients
with Lennox-Gastaut syndrome (LGS) aged between 4 and 30 years old. The trial
took into account other, overseas trials of the drug; during the maintenance
period, patients received either placebo or rufinamide at a dose of 1,000 mg,
1,800 mg, 2,400 mg or 3,200 mg daily depending on their weight. Results showed
that the patients who were administered rufinamide experienced a significant
reduction in tonic and atonic seizure frequency (change in seizure frequency;
rufinamide arm: -24.2%; placebo arm: -3.3%; p=0.003) and overall seizure
frequency (change in seizure frequency; rufinamide arm: -32.9%; placebo arm:
-3.1%; p=< 0.001). The most frequently observed adverse reactions were
decreased appetite, somnolence and vomiting. 
Phase III Clinical Study Overseas 
A 12-week double-blind comparative study of rufinamide versus placebo as
adjunctive therapy to other antiepileptic drugs was conducted in 138 patients
with LGS aged between 4 and 30 years old. During the maintenance period,
patients received either placebo or rufinamide at a dose of 1,000 mg, 1,800 mg,
2,400 mg or 3,200 mg daily depending on their weight (target dose of
approximately 45 mg/kg per day). Results showed that the patients who were
administered rufinamide experienced a significant reduction in tonic and atonic
seizure frequency (change in seizure frequency; rufinamide arm: -42.5%; placebo
arm: 1.4%; p=< 0.0001) and overall seizure frequency (change in seizure
frequency; rufinamide arm: -32.7%; placebo arm: -11.7%; p=0.0015). The most
frequently observed adverse reactions were somnolence, decreased appetite and
vomiting. 
Eisai's Commitment to Epilepsy 
Eisai defines epilepsy as a therapeutic area of focus. In addition to
Lennox-Gastaut syndrome treatment Inovelon(R)/Banzel(R), Eisai currently
markets Zonegran(R) (sodium/calcium channel blocking antiepileptic agent
marketed in Europe, the United States and Asia under license from the
originator, Dainippon Sumitomo Pharma Co., Ltd.) and Zebinix(R)
(voltage-dependent sodium channel-blocking antiepileptic agent marketed in
Europe under license from the originator, BIAL-Portela & Ca S.A.) for the
treatment of partial-onset seizures, and the anticonvulsant agent Fostoin(R)
(water-soluble pro-drug of phenytoin marketed in Japan with co-promotion
partner Nobelpharma Co., Ltd.) for use in the treatment of conditions such as
status epilepticus. 
Eisai also received approval to market Fycompa(R) (perampanel), an AMPA
antagonist discovered and developed in-house, as a first-in-class treatment for
partial-onset seizures, in the European Union in July 2012 and in United States
in October 2012, with the drug having already been launched in six countries
across Europe as of March 2013. Perampanel is currently in Phase III clinical
development in Japan for partial-onset seizures and Eisai is also conducting
Phase III clinical studies as part of a global development program for the drug
in the treatment of generalized epilepsy. By offering multiple treatment
options as part of an extensive epilepsy product portfolio, Eisai seeks to make
further contributions to address the diversified needs of, and increase the
benefits provided to, patients with epilepsy and their families. 
About Eisai 
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. 
Contact: 
Eisai Co., Ltd.
Public Relations Department
+81-3-3817-5120 
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