Japan's Chugai touts publication of PhI emicizumab study in NEJM

Lab work
Lab work

Tokyo-based Chugai Pharmaceutical touted published data on a Phase I trial for hemophilia A candidate ACE001JP in the New England Journal of Medicine (NEJM) that the company said demonstrated a "clinically acceptable safety profile" and potential patient benefit.

The candidate--the bispecific antibody emicizumab--was used in a trial that involved 18 Japanese patients with severe hemophilia and eyed for preventing bleeding in hemophilia A patients, both with and without factor VIII (FVIII) inhibitors, according to a release.

“A great challenge with the current treatments for hemophilia A is that these patients need frequent intravenous injections and face the possibility of developing inhibitors to FVIII,” Chugai’s director and executive vice president Yutaka Tanaka said.


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"The study results indicated a potential for benefit from emicizumab in treating hemophilia A patients with inhibitors with once-weekly subcutaneous injection. With these findings, we expect that emicizumab may be a new treatment option to fulfill unmet medical needs of hemophilia A patients.”

The candidate, labeled as ACE910/emicizumab in late-stage global trials slated to wind up by 2018, received U.S. FDA breakthrough therapy designation in late 2015. It is currently being developed with Roche ($RHBBY), which holds a majority stake in Chugai.

Earlier this month, Chugai said it had been slapped with a lawsuit in a Tokyo court alleging a patent infringement on ACE910 by Baxter International ($BAX) spinoff Baxalta ($BXLT).

In response, Chugai said it expects to win in court.

"Chugai is confident that emicizumab does not infringe the plaintiff’s patent, and plan to vigorously pursue our defense through the entire court process to prove non-infringement," the release said. "Therefore, no changes are expected to be made to the financial prospects of fiscal year 2016."

- here's the release
- and the NEJM study


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