Yearning for new cancer sales, Eisai hits back at Germany's Halaven reproof

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After suffering key patent losses, Eisai's new cancer meds are critical to its rebound. But for the second time this summer, the Japanese drugmaker has hit a hurdle with Europe's cost watchdogs. First, England's NICE turned away Lenvima, and now Eisai says it’s “bewildered” by a poor Halaven critique from Germany’s tough gatekeeper, IQWiG.

Eisai “cannot understand” IQWiG’s decision to turn away the new drug as a liposarcoma treatment. The agency decided that Halaven's survival advantage has not been proven, “despite compelling Phase III data which show an overall survival benefit,” Dr. Patrik Höller, Eisai GMbH oncology director, said in a statement.

According to an IQWiG release translation, Eisai’s comparator study between Halaven and dacarbazine was flawed because “instead of in combination with another drug (doxorubicin) dacarbazine was given as monotherapy and at the beginning of therapy.” IQWiG also had a problem with dosage in the trial. “The study results are therefore not suitable in order to derive an additional benefit,” according to the release.

But Eisai said the regulator “ignores pivotal Phase III data” with that decision. The Japanese drugmaker commented that the study “demonstrated clearly” that Halaven--approved in Europe in May for advanced liposarcoma--is “the first and only” monotherapy to demonstrate a survival edge in the advanced cancer type.

“The clinical importance of this unprecedented survival benefit cannot be overstated for people who live with advanced liposarcoma and urgently need new and effective treatment options, such as eribulin,” Eisai GmbH medical director Dr. Helga Schmitz said in a statement.

A final decision by Germany's Federal Joint Committee isn’t expected until December, after more consideration of the arguments on both sides. As the discussions unfold, Eisai will push for some form of a reversal, in light of a larger company focus to grow sales for new meds, hoping to offset patent losses on older ones.

Eisai cut 200 jobs last year as it continued to suffer from generic competition for its Alzheimer's drug Aricept and struggled with newer launches.

One new effort--a marketing partnership with Arena Pharmaceuticals ($ARNA) on the obesity drug Belviq--hasn't paid off with the level of sales Eisai had expected. The company ramped up its sales force and expanded its DTC campaign for Belviq in 2014, looking to swing numbers for the drug northward. But though the numbers initially grew, the drug brought in $8 million for Eisai sales in Q4 2015, a top-line haul that declined for the fourth straight quarter.

Meanwhile, analysts are skeptical that Lenvima, a thyroid cancer treatment, can hit the company's ambitious sales projections; Eisai has said Lenvima can bring in $1 billion by 2020 if everything goes according to plan.

So far, it's not. The company is in a separate fight in the U.K., where NICE has delayed its Lenvima review. There, it joined a slew of drugmakers criticizing the institute’s assessment techniques, adding that it’d consider legal options and its future investment in the country due to the delay. The European Commission approved the med in May 2015, but with the NICE delay, it won’t receive a recommendation until at least April 2017, Eisai told Reuters at the time.

- here's the IQWiG release
- read Eisai's statement

Special Report: Big Patent Expirations of 2010 - Aricept

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