A raft of new results plus an update on ongoing clinical trials featuring Eisai’s epilepsy portfolio have been presented at the European Congress on Epileptology held this week in London.
For Fycompa (perampanel), Eisai’s first-in-class, AMPA-type glutamate receptor antagonist, pooled data from Phase III studies 304, 305 and 306 were presented. Results showed a significant reduction in seizure frequency, across all partial-onset seizure types, with most adverse events considered mild to moderate.
Open label extension data from these studies show sustained efficacy with over 70% patient retention, plus similar efficacy and tolerability results in adolescents and adults, said Bernhard Steinhoff of the Kork Epilepsy Centre in Germany. Other data on the use of Zonegran (zonisamide) in elderly and paediatric patient populations were presented, as were further details of major ongoing studies including Zebinix (eslicarbazepine) in partial-onset seizures (EPOS) study and a Zebinix monotherapy study currently underway in 170 centres in 30 countries.
Speaking to PharmaTimes World News, Gary Hendler, president of Eisai EMEA & Russia reiterated the company’s goal to lead the EU epilepsy market by 2015. “Our aspiration is to become the number one company in epilepsy. It’s as simple as that.”
However, with four marketed treatments for epilepsy, might Eisai be trying to commercialise too many drugs in the same space? “Not at all. Our marketed treatments have different modes of action, which can be complementary or additive,” he said.
According to Mr Hendler, uptake of Fycompa in the first four markets in which it has been launched (UK, Germany, Austria and Denmark) has “surpassed expectations” with refill prescriptions showing patients moving from the 2mg to the 4mg dose.
However he acknowledged that challenges lay ahead and that the company needed to move Zebinix to a monotherapy indication as rapidly as data permits. “60% of monotherapy patients get treated with carbamazepine – there is a huge opportunity to move into that space.”
Mr Hendler said that “we also have the challenge of life cycle management with patent cliffs and loss of exclusivity. We will lose the data exclusivity of Zonegran in 2015, which coincides with our ‘milestone’ goal – so it is very important Zebinix stands up for itself and Fycompa takes off rapidly".
He added that emerging data on the unique mode of action and tolerability of Zebinix were encouraging, because some had called the drug a “me three” after the older carbamazepine and the Novartis offering Trileptal (oxcarbazepine). “As the data are starting to mature, we are seeing the differences being teased out. The beauty of Zebinix is that it is very well tolerated and that is the key driver because all three drugs are similarly effective in terms of seizure reduction, severity or responder rates.”