Eisai opens Fycompa UK manufacturing line
pharmafile | September 25, 2012 | News story | Manufacturing and Production, Sales and Marketing | Eisai, Fycompa
Eisai has opened a new solid dose production line for epilepsy drug Fycompa at its UK base in Hatfield, Hertfordshire.
As revealed by InPharm last week, Fycompa (perampanel) is the first of the company’s drugs to be manufactured outside Japan.
The Tokyo-based firm’s UK subsidiary Eisai Manufacturing, housed at Eisai’s EMEA HQ at Hatfield, has received a licence to make Fycompa from European regulators.
The first-in-class AMPA receptor antagonist was launched earlier this month in the UK, Germany, Austria and Denmark.
The FDA is set to give Fycompa the green light next month and Eisai says it will seek permission from regulatory authorities worldwide, to allow the company to use Hatfield as a global manufacturing site for all Fycompa markets.
The once-daily pill has been indicated as as an adjunctive treatment for partial-onset seizures, with or without secondarily generalised seizures.
It has a different mechanism to current anti-epileptic drugs and blocks postsynaptic glutamate AMPA receptors – seizures are primarily mediated by the neurotransmitter glutamate.
The drug was discovered by UK scientists in collaboration with Japanese colleagues, with work on it done at Eisai London Laboratories at UCL.
Eisai expects Fycompa to be available in most of the rest of Europe over the next year: around six million people on the continent suffer from epilepsy.
Eisai already has several treatments in this field: Zonegran and Zebinix for adult patients with partial-onset seizures, and Inovelon for seizures associated with Lennox-Gastaut syndrome, a severe form of early childhood-onset epilepsy.
Eisai will be hoping to capitalise on significant market shifts: GlaxoSmithKline and Valeant’s Potiga (ezogabine) was approved in the US last year but some big drugs, including GSK’s blockbuster Lamictal and Johnson & Johnson’s Topomax, are due to go off patent.
Adam Hill
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