Eisai Seeks Global Approval For Cancer Agent Eribulin As Aricept Patent Expiration Looms

TOKYO - Eisai March 31 said it had applied for manufacturing and marketing approval with Japan's Ministry of Health, Labor and Welfare; U.S. FDA and the European Medicines Agency for eribulin for the treatment of locally advanced and metastatic breast cancer.

"Eisai clearly is rushing to launch eribulin because its Aricept patent expires in the U.S. in November and it needs next core products," Fujio Ando, a medical and pharmaceutical industry analyst with Chibagin Asset Management Co. told PharmAsia News.

Eisai spokesman Tadaharu Mitsui said the company is projecting peak-year global sales of eribulin to exceed $1 billion. He declined to comment on when that peak year would likely occur once the drug is approved, but Ando said "it better be before 2015" because of a substantial revenue contraction possibility resulting from the patent expiration on Aricept (donepezil). In fiscal 2009, ended in March 2010, the Alzheimer's disease drug global sales topped $3 billion, Mitsui said.

To cope with the looming patent expiration of Aricept, Eisai has found a combination of efficiency models and belt-tightening - along with a pretty aggressive push to establish an oncology franchise - to realize growth after 2011. The company expects a $1.2 billion decrease of U.S. Aricept sales in fiscal 2012 following the patient expiration (Also see "With Aricept Losses Looming, Eisai Looks To Emerging Markets, Flexibility For New Growth" - Scrip, 8 Mar, 2010.).

Ando predicted that eribulin stands "a fairly good" chance of gaining approval, probably next year. Mitsui said Eisai is gearing to announce applications of more products that it hopes will become the company's core products later this year and next, particularly in the oncology area.

Eisai said March 26 that the independent data monitoring committee had recommended that the company continue clinical trials of its proprietary toll-like receptor 4 antagonist eritoran for the treatment of severe sepsis, in a setback for the company that was expected to submit its application for the drug by the end of March.

The spokesman said Eisai is gearing up to submit the application for the drug by year-end.

In submitting the applications for eribulin, Eisai's EMBRACE study enrolled 762 women with locally recurrent or metastatic breast cancer who were previously treated with at least two prior chemotherapy regimens. Results demonstrated a "statistically significant improvement in overall survival," according to Eisai.

Major side effects were asthenia, neutropenia, alopecia, nausea and peripheral neuropathy, it said.

Quintiles announced late last year that it would collaborate with Eisai to conduct 11 proof-of-concept trials in six oncology compounds. The goal of the collaboration is to determine the potential efficacy of the compounds in the shortest time possible. The Japanese drug maker will be conducting 18 trials of its own on the six compounds from its pipeline as well (Also see "Quintiles And Eisai Collaborate To Develop Cancer Compounds" - Scrip, 2 Nov, 2009.).

Earlier this month, Eisai obtained U.S. FDA approval for five-day dosing of Dacogen (decitabine) injection for patients with myelodysplastic syndrome .

- Toshio Aritake ([email protected])

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