Swiss-based Neovii Pharmaceuticals AG and Singapore-based Mundipharma Pte Ltd have entered into an agreement giving Mundipharma the rights to develop, distribute, and support Grafalon in China and Japan starting in November 2018.
Grafalon, a polyclonal antibody immunosuppressant, is a rabbit anti-human T-lymphocyte immunoglobulin used as part of immunosuppressive regimens for the prevention of graft-vs-host disease (GvHD) in stem cell transplantation, prevention, and treatment of rejection in solid organ transplantation, or as an immunosuppressive in the treatment of aplastic anemia.
The drug currently is approved in China for prevention of rejection and the treatment of acute steroid resistant rejection in solid organ transplants.
While Grafalon is approved and used for GvHD prophylaxis in some 50 countries, U.S. patients currently don’t have an FDA approved treatment option to prevent chronic GvHD, according to Neovii.
Phase III trial data released last fall for Grafalon anti-T lymphocyte globulin as a treatment for chronic GvHD did not meet its primary endpoint, although the company reported that the trial did show “a statistically significant reduction in acute GVHD II-IV as well as moderate and severe cGVHD.”
Privately owned Neovii, headquartered in Rapperswil, Switzerland, maintains a branch office, Neovii Biotech NA, Inc., in Lexington, MA, and a biotechnology manufacturing facility in Graefelfing, Germany. Mundipharma is a network of privately owned independent associated companies covering pharmaceutical markets in Asia-Pacific, Latin America, the Middle East, and Africa.