Tokyo-based Chugai Pharmaceuticals has been slapped with a lawsuit in a Tokyo court for its hemophilia candidate ACE910 by Baxter International ($BAX) spin-off Baxalta, alleging a patent infringement.
The candidate, emicizumab, is now in late-stage trials that are backed by Roche ($RHHBY), which holds a majority stake in Chugai, that are slated to wind up by 2018.
But Baxalta, according to a release from Chugai, alleges the candidate infringes a key patent and wants all work to halt, including "manufacture, usage, transfer, exportation, and offer of any transfer regarding emicizumab."
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," according to the Chugai release. "Therefore, no changes are expected to be made to the financial prospects of fiscal year 2016."
Baxalta ($BXLT) is currently a target of acquisition by Shire ($SHPG) that should be completed in the coming month, with the company a leader in hemophilia therapies.
Chugai's development for the hemophilia indication stemmed from earlier work on a bispecific antibody. Roche licensed the product from Chugai in 2014 for global development for hemophilia A. Roche's biologics arm Genentech has moved to start a Phase III trial this year in patients without Factor VIII inhibitors.
In September of 2015, ACE910 received a U.S. FDA breakthrough therapy designation for hemophilia A.
- here's the release from Chugai