Eisai Takes Legal Action In Federal Court Alleging Unreasonable Delay In DEA Scheduling Of FYCOMPA™ (perampanel) Epilepsy Drug Still Not Available to Patients 10 Months After FDA Approval

WOODCLIFF LAKE, N.J., Aug. 19, 2013 /PRNewswire/ -- Eisai Inc. filed a petition today with the U.S. Court of Appeals for the District of Columbia asking the court to direct the Drug Enforcement Administration (DEA) to promptly schedule the company's epilepsy drug so that it can make it available to patients.

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FYCOMPA™ (perampanel), a new chemical entity (NCE), was approved by the Food and Drug Administration (FDA) in October 2012 as an adjunctive therapy for the treatment of partial onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older. The FDA sent its scheduling recommendation for FYCOMPA to the DEA in January 2013, but seven months later the DEA has not yet begun the scheduling process. 

In its petition for a writ of mandamus, Eisai asserted that the DEA has "unreasonably" and "egregiously" delayed the scheduling of FYCOMPA, a delay which means that thousands of potential patients suffering with partial onset seizures – a serious medical condition for which there is great unmet medical need – cannot obtain the drug. The papers also challenge the justification for the delay and highlight the lack of any timetable, predictability, or transparency related to the DEA's scheduling process. In addition, it explains that the DEA's delay also continues to harm Eisai by preventing it from launching FYCOMPA in the United States even though Eisai demonstrated to the satisfaction of the FDA that the drug is safe and effective when prescribed in accordance with its labeling.

Partial onset seizures occur in about 60 percent of those with epilepsy and approximately 30 percent of these patients -- several hundred thousand people in the U.S. -- have seizures that are not controlled.

Attached to the petition are several letters from the epilepsy community urging expedited scheduling of FYCOMPA and other epilepsy drugs.

"People with epilepsy, their caregivers, or parents of children with epilepsy find it very frustrating to wait for an additional treatment option for seizure control due to DEA delay," said Phil Gattone, President and CEO of the Epilepsy Foundation, a leading patient organization representing the 2.2 million Americans with epilepsy and their families. "It is even more disheartening to know that the system is not required to have a clear timeline for consumers."

Michael Rogawski, M.D., Ph.D., a professor of neurology at the University of California, Davis, sent the DEA a personal letter expressing his frustration with the agency's significant delay in scheduling FYCOMPA."There are a large number of patients who could benefit from FYCOMPA if it were available. It is unreasonable to delay access of this medication to patients who could potentially benefit," he said.

"We have reached out to the DEA several times to better understand why there is such a lengthy delay in scheduling this drug and making it available to patients," said Allen Waxman, Senior Vice President and General Counsel of Eisai Inc. "Unfortunately, 10 months after FDA approval, we still await the initiation of the DEA's scheduling process."

FDA requires that sponsors of drugs that FDA recommends for scheduling wait until the scheduling process is finished before commercially distributing the product. The scheduling process for NCEs, such as FYCOMPA, has lengthened over the past fifteen years from an average of 49 days during the 1997 to 1999 timeframe, to an average of 237 days between 2009 and 2013.  

Important Safety Information

Mental (psychiatric) Problems
FYCOMPA may cause new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability, being suspicious or distrustful (believing things that are not true) or other unusual or extreme changes in behavior or mood. Patients should call their healthcare provider right away if they have any new or worsening mental problems while taking FYCOMPA. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol.

Suicidal Thoughts and Actions
Antiepileptic drugs, including FYCOMPA, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients should call their healthcare provider right away if they have any new or worsening symptoms of depression, any unusual or sudden changes in mood, feelings, behavior, or suicidal thoughts, behavior, or thoughts of self-harm that they have never had before or may be worse than before. 

Dizziness, Vertigo (sense of spinning) and Problems Walking Normally
Patients may have problems walking normally if they are unsteady because they feel dizzy. These symptoms may increase when their dose of FYCOMPA is increased. A patient's risk of feeling dizzy and having problems walking normally may be higher if they are elderly.

Sleepiness and Tiredness
FYCOMPA may make a patient feel sleepy or tired. Patients should not drive, operate heavy machinery, or do other dangerous activities until they know how FYCOMPA affects them. A patient's risk of feeling sleepy and tired may be higher if they are elderly.

Falls
Taking FYCOMPA may increase a patient's chance of falling. These falls can cause serious injuries. A patient's risk of falling may be higher if they are elderly.

Withdrawal of AEDs
Patients must not stop FYCOMPA without first talking to their healthcare provider. Stopping FYCOMPA suddenly can cause serious problems and can cause patients to have seizures more often.

Drug Abuse and Dependence
FYCOMPA can be abused. Patients should tell their healthcare provider if they have abused prescription medicines, street drugs, or alcohol in the past. Physical dependence is characterized by withdrawal symptoms. The potential for FYCOMPA to produce withdrawal symptoms has not been adequately studied.

Pregnancy and Nursing
It is not known if FYCOMPA can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant while taking FYCOMPA. Patients and their healthcare providers will decide if they should take FYCOMPA while they are pregnant. If a patient becomes pregnant while taking FYCOMPA, she should talk to her healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334). It is not known if FYCOMPA passes into breast milk or if it can harm a baby. Patients should talk to their healthcare provider about the best way to feed their baby if they take FYCOMPA.

Liver and Kidney Problems
Patients should tell their healthcare provider if they have liver or kidney problems. They should not take FYCOMPA if they have severe kidney or liver problems.

Interactions with Other Medicines
Taking FYCOMPA with certain other medicines, such as birth control pills, carbamazepine, phenytoin, oxcarbazepine, rifampicin, and St. John's Wort, can cause side effects or reduce either drug's benefit. Patients should not drink alcohol or take other medicines that make them sleepy or dizzy while taking FYCOMPA until they talk to their healthcare provider. FYCOMPA taken with alcohol or medicines that cause sleepiness or dizziness may make their sleepiness or dizziness worse.

Most Common Adverse Reactions
In clinical trials, the most common adverse reactions seen in patients receiving FYCOMPA, were dizziness, sleepiness, tiredness, irritability, falls, nausea, problems with muscle coordination, problems walking normally, vertigo and weight gain.

Please see the FYCOMPA full Prescribing Information.

About Epilepsy
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. According to the Institute of Medicine, epilepsy is one of the most common neurological disorders, affecting 2.2 million people in the United States. About 60 percent of people with epilepsy have partial-onset seizures. In about 30 percent of these patients, the seizures remain uncontrolled with current treatment.

Epilepsy is a therapeutic area of focus for Eisai. The company continues to make further contributions to help address the diversified needs of epilepsy patients and their families as part of its corporate human health care (hhc) mission.

About FYCOMPA (perampanel)
FYCOMPA is an oral medication taken once daily and is the first FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain. Glutamate is the primary excitatory neurotransmitter in the central nervous system.

Discovered and developed by Eisai, FYCOMPA has been approved in more than 30 countries and is currently available in the U.K., Sweden, Norway, Denmark, Austria, Switzerland and Canada.

FYCOMPA will be supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets.

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., our passionate commitment to patient care 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.

Media Inquiries

Investor Inquiries

Laurie Landau

Alex Scott

Eisai Inc.

Eisai Inc.

201-746-2510

201-746-2177

SOURCE Eisai Inc.



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