Struggling Eisai files its thyroid cancer drug lenvatinib in U.S., EU

Still suffering from the loss of patent protection on its big Alzheimer's drug Aricept, Japan's Eisai said today that the company had fired off a pair of applications for its new cancer drug to U.S. as well as European regulators.

Eisai is seeking to gain approvals in both markets to sell lenvatinib for a certain type of thyroid cancer after registering positive progression-free survival data in a late-stage study funded by SFJ Pharma, which is pursuing a novel approach to partnering on late-stage therapies.

Back in March the Tokyo-based pharma said that lenvatinib--a tyrosine kinase receptor (TKR) inhibitor--had hit the primary endpoint in the SELECT study. And the company is seeking an approval for progressive radioiodine-refractory differentiated thyroid cancer.

That news is a solid plus for SFJ Pharma, a startup trial operation that funded the study under a new development model hatched back in 2011. SFJ fronted the cash for the study in exchange for a set of milestones for a successful outcome of the study, which was conducted by Eisai. This new model for drug development that has attracted attention at Pfizer and other pharma operations looking to spread the risk and cost of R&D.

Eisai says it has several other Phase III and Phase II studies of the drug underway in other tumor types. The company earlier reported plans to get the drug made at one of its U.K. facilities.

Eisai has experienced several setbacks in its quest to recover from the loss of Aricept. While it heralded new applications for lenvatinib, the company was also expressing its outrage at once again seeing its epilepsy drug Fycompa spurned by German regulators, who see it as nothing special compared to therapies already on the market. Germany has a tough new set of regulations in place that demand to see clear evidence of superiority in a new drug before the country will agree to pay a premium for it.

In the U.S., Eisai filed suit against the FDA recently complaining that the agency started the clock ticking on its 5-year exclusivity period for Fycompa and the weight-loss drug Belviq well before it had the drug labels finalized. And a few days ago the company was forced to report that its non-small cell cancer drug eribulin failed a Phase III study.

Eisai also announced a licensing deal today for one of its in-house proton pump inhibitors, granting Zeria Pharmaceutical the right to co-develop and market the therapy in Japan.

- here's the release

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