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Eisai expands into South Africa

Files Halaven and Fycompa for approval


Eisai has filed its two key new products for approval in South Africa, moving its expansion plans for the country into the next phase.

The Japanese pharma company has submitted its breast cancer drug Halaven (eribulin) and epilepsy treatment Fycompa (perampanel) to the Medicines Control Council.

Gary Hendler, president and CEO of Eisai Europe, Middle East, Africa and Russian (EMEA) business, said: "Eisai has been successfully operating in Europe for more than 20 years and we are proud to be bringing effective medicines to countries outside this region.

"The filing of Halaven and Fycompa in South Africa shows our commitment to our expansion plans to provide effective treatments to more patients around the world. This also further validates our human healthcare  mission to satisfy unmet medical needs and contribute to the health and well-being of people worldwide."

The South African pharmaceutical market is expected to double in size over the next six years, aided by government plans to introduce a universal healthcare system.

Halaven was approved in Europe in 2011 and the US in 2010. Those approvals were based on the EMBRACE study, which will also form the backbone of the drug's South African filing,

A phase III open-label, randomised, global, multi-centre study, EMBRACE involved 762 patients.

It showed that patients treated with Halaven survived a median of 2.5 months longer than patients who received treatment of a physician's choice (TPC), with overall survival of 13.1 months vs TPC 10.6 months.

TPC represents active treatment options currently used by doctors in real world clinical practice, and the majority (96 per cent) of patients in the TPC arm received chemotherapy.

In South Africa, an estimated 8,000 South African women are diagnosed with breast cancer every year and it is predicted that 20 per cent will die from the disease.

Meanwhile, Fycompa has been approved by the European Commission (EC) and is now available in the UK, Germany, Austria, Denmark, Sweden and Norway as an adjunctive therapy for patients with partial-onset seizures (the most common form of epilepsy) aged 12 years and above.

Eisai said it expects the drug's availability in South Africa, where an estimated 1 in 100 people have epilepsy, to mark a significant step for people with condition.

29th January 2013


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