Eisai says its new thyroid cancer drug is a sure blockbuster

Eisai, on the mend after some big patent losses, believes its top prospect in oncology can bring in peak annual sales north of $1 billion, beginning with thyroid cancer and expanding to treat other tumor types.

The drug, lenvatinib, is a tyrosine kinase receptor inhibitor that blocks the growth agents tumors need to proliferate. In Phase III results published in The New England Journal of Medicine today, the oral treatment significantly improved progression-free survival in thyroid cancer when compared to placebo. Eisai submitted that data to regulators last year, and, thanks to the FDA's priority review system, the company expects to win U.S. approval to treat thyroid cancer in the coming months.

But lenvatinib's full potential depends on its ability to have a marked effect on other cancers, Eisai told The Wall Street Journal. The Japanese drugmaker is plotting further late-stage trials in liver, kidney, lung and endometrial cancers, and, if it runs the table, lenvatinib could gross more than $1 billion a year by 2020, Eisai Vice President Ivan Cheung told the Journal.

"We believe it is a blockbuster with the additional indications," Cheung said.

That might be a bit hasty considering lenvatinib has cleared just one Phase III hurdle, but Eisai, starved for new products, is understandably excited. Thanks in part to recent patent expiries for the Alzheimer's disease drug Aricept and acid reflux treatment AcipHex, Eisai's revenues are on the decline. And the company's latest launches, the weight-loss drug Belviq and seizure medication Fycompa, are facing exclusivity problems of their own.

- read the study results (PDF)
- check out the WSJ story