mAbxience and Sandoz have entered a licensing, development, manufacturing and commercialization agreement covering a proposed emicizumab biosimilar candidate, mAbxience said. mAbxience is majority-owned by Fresenius SE & Co. KGaA with partial ownership from Insud Pharma, and Sandoz is listed on SIX and OTCQX. Financial terms of the agreement were not disclosed.
Under the agreement, mAbxience will carry out development and manufacturing at GMP-approved facilities in Spain and Argentina. Sandoz will hold exclusive commercialization rights globally, excluding Argentina, Uruguay and Paraguay.
The candidate references Hemlibra (emicizumab) and is indicated for the treatment of hemophilia A. The release puts the estimated global reference market at approximately USD 5.7 billion. Hemophilia A is described as a rare genetic disorder caused by insufficient or defective factor VIII, a blood-clotting protein, and as the most common form of hemophilia, accounting for around 80 percent of all cases worldwide.
Jurgen Van Broeck, chief executive of mAbxience, said the agreement recognizes the company's development and manufacturing platform and its teams, and that combining that work with Sandoz's biosimilars reach offers a pathway to broaden access to treatment for patients living with hemophilia A. The company said the candidate would extend its pipeline into hemophilia A and add to a pipeline that covers oncology, immunology, bone diseases and other specialty care areas.