Eisai and Glenmark Reach Settlement over Generic Version of BANZEL® (rufinamide)

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Apr 30, 2015, 10:09 ET

WOODCLIFF LAKE, N.J., April 30, 2015 /PRNewswire/ -- Eisai Inc. and Eisai Co., Ltd. have entered into a settlement agreement with Glenmark Pharmaceuticals, Ltd., Glenmark Generics Ltd., and Glenmark Generics, Inc., USA ("Glenmark"), to resolve their patent litigation relating to Eisai's BANZEL^® (rufinamide) in the United States. As a result of the settlement, Glenmark will be permitted to market a generic version of BANZEL in the United States on May 30, 2022, or potentially earlier under certain circumstances. Additional terms of the settlement agreement are confidential.

About BANZEL^®(rufinamide)
BANZEL^® (rufinamide) is an anti-epileptic drug indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 1 year and older and adults.

BANZEL is currently available in 200 and 400 mg tablets and in a 40 mg/mL oral suspension formula for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 1 year and older and adults. It has been on the market since its FDA approval on November 14, 2008.

BANZEL Important Safety Information

Contraindication:

BANZEL is contraindicated in patients with Familial Short QT syndrome.

Warnings:

AEDs increase the risk of suicidal thoughts or behavior in patients. Patients, their caregivers, and families should be informed of the risk and advised to monitor and report any emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior, or thoughts of self-harm. If these symptoms occur, consider if it may be related to the AED or illness because epilepsy itself can increase these risks.
Use of BANZEL has been associated with central nervous system-related adverse reactions, such as somnolence or fatigue, coordination abnormalities, dizziness, gait disturbances, and ataxia.

Precautions:

Formal cardiac ECG studies demonstrated shortening of the QT interval (mean = 20 msec, for doses greater than or equal to 2400 mg twice daily) with BANZEL. Caution should be used when administering BANZEL with other drugs that shorten the QT interval.
Multi-organ hypersensitivity syndrome has been reported in association with BANZEL therapy. In clinical trials, hypersensitivity reactions occurred in children less than 12 years of age and within 4 weeks of starting BANZEL therapy. In addition, rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms and Stevens-Johnson syndrome have been reported in association with rufinamide therapy post marketing. If any of these reactions are suspected, BANZEL should be discontinued and alternative treatment started. All patients who develop a rash while taking BANZEL must be closely supervised.
As with all AEDs, BANZEL should be gradually withdrawn to minimize the risk of increased seizure frequency.

Adverse reactions:

In the pooled, double-blind, adjunctive therapy studies in adults and pediatric patients ages 4 and older, the most commonly observed (greater than or equal to 10%) adverse reactions with BANZEL vs placebo, respectively, were headache (25% vs 20%), dizziness (17% vs 10%), fatigue (15% vs 9%), somnolence (13% vs 9%), and nausea (11% vs 7%).

In a multicenter, parallel group, open-label study in pediatric patients (1 year to less than 4 years of age) the most commonly observed (greater than or equal to 10%) adverse reactions and with a higher frequency with BANZEL vs any other AED, respectively, were vomiting (24% vs 9%), somnolence (16% vs 0%), constipation (12% vs 9%), cough (12% vs 9%), bronchitis (12% vs 0%), rash (12% vs 9%), and decreased appetite (12% vs 9%).

Please see the BANZEL Full Prescribing Information

Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.

Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including oncology and neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries. For more information about Eisai Co., Ltd., please visit www.eisai.com.