Eisai Receives Marketing Approval for Zonegran® (zonisamide) Monotherapy Treatment for Epilepsy

HATFIELD, England, July 3, 2012 /PRNewswire/ --

The European Medicines Agency (EMA) has issued Marketing Authorisation Approval (MAA) to extend the use of once-daily Zonegran^® (zonisamide) from adjunctive therapy to also include monotherapy for the treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy.

Zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure which is unrelated to any other AEDs.^[1] For patients with newly diagnosed epilepsy, monotherapy is the preferred option for managing their condition as this reduces the potential for adverse drug interactions.^[2]

Commenting on the MAA, Michel Baulac, Head of the Epilepsy department at the Pitie-Salpetrière Hospital, Paris, France said, "Monotherapy is the optimal treatment approach for managing epilepsy. Therefore, the EU approval of zonisamide monotherapy is of real significance for newly diagnosed epilepsy patients who will, for the first time, be able to access this proven treatment as a first-line option in their care pathway."

There are an estimated six million people living with epilepsy in Europe^[3] and an estimated 50 million people worldwide.^[4] The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge in some patients.

"Zonegran is already a successful once-daily, add-on therapy for patients with epilepsy. The new monotherapy indication means this important treatment can now be used in newly diagnosed patients to help improve seizure control," said Dr Bettina Bauer, Head of EMEA Epilepsy Business Unit, Eisai Europe. "Zonegran is one of only six AEDs available as monotherapy, providing doctors with a new option to tailor treatment to individual patient needs."

"The EU approval of Zonegran monotherapy illustrates Eisai's commitment to bringing new therapeutic options to patients with epilepsy," continued Dr Bauer. "We will be working closely with health authorities and clinicians across Europe to ensure patients have access to this treatment from first diagnosis."

The efficacy and safety of zonisamide as monotherapy has been demonstrated in a double-blind, randomised, multicentre study of 583 newly diagnosed adult partial epilepsy patients, which compared the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy. The study's primary endpoint was the proportion of seizure-free patients at six months. Zonisamide demonstrated high response rates for achieving seizure freedom in newly diagnosed patients with epilepsy,^[5] similar to controlled release carbamazepine. In the majority of patients, seizure freedom was achieved at the target dose of 300 mg. Zonisamide demonstrated non-inferiority to carbamazepine, was well tolerated and had no apparent safety concerns after one year of treatment at doses ranging from 300 to 500 mg/day.

The development of zonisamide underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.

About Zonegran (zonisamide)

Zonisamide is licensed in Europe as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. In addition, zonisamide is also indicated as adjunctive therapy in the treatment of partial seizures (with or without generalisation) in adults with epilepsy. It has a broad spectrum of anti-epileptic modes of action and has no appreciable effects on steady-state plasma concentrations of other AEDs, such as phenytoin, carbamazepine and valproate.^[1]

Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The recommended initial daily dose for adjunctive use is 50mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg.^[1]

For more information please visit: http://www.zonegran.eu

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe.^[6] There are an estimated six million people living with epilepsy in Europe^[3], and an estimated 50 million people with the condition worldwide^[3]. Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity causing seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.

About Eisai Europe in Epilepsy

Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in the European market.

In Europe, Eisai currently has three marketed treatments including:

• Zonegran^® (zonisamide) as monotherapy and adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
• Zebinix^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation
• Inovelon^® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years

In addition to three marketed AEDs, Eisai's new Phase III AED perampanel (Fycompa^®), the first in a new class of epilepsy treatment for use as an adjunctive treatment for focal (partial) seizures, with or without secondary generalised seizures, in patients with epilepsy aged 12 years and older, received CHMP positive opinion in May 2012 and is expected to launch in September 2012.

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical companies and has defined its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc). Eisai recently expanded their UK Hatfield facility which now supports the company's growing European, Middle Eastern and African (EMEA) business.

Eisai concentrates its R&D activities in three key areas:

• Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression
• Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
• Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, Slovenia, the Netherlands, and Belgium.

For further information please visit our web site http://www.eisai.com

References

1. Eisai Ltd 2012. Zonegran Summary of Product Characteristics

2. St. Louis, K. Rosenfeld. W. Bramley, T. Antiepileptic Drug Monotherapy: The Initial Approach in Epilepsy Management (2009) &(2): 77 - 72

3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available from; http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf (Accessed June 2011)

4. Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-didyouknow (Accessed June 2011)

5. Baulac, M. Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurology (2012), 11 (7) 579 - 588

6. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224 - 2233

Date of preparation: July 2012

Job code: Zonegran-UK2444