The candidate is in early-stage development and references Hemlibra (emicizumab), a medicine used to treat patients with haemophilia A. The companies said the reference medicine has estimated global sales of $5.7bn.
Under the agreement, mAbxience will develop and manufacture the proposed biosimilar at its good manufacturing practice (GMP)-approved facilities in Argentina and Spain.
Sandoz will receive exclusive global commercialisation rights, excluding Argentina, Paraguay and Uruguay. The financial terms were not disclosed.
The agreement is said to be the first haemophilia medicine in Sandoz’s biosimilar pipeline. It also expands mAbxience’s rare-disease portfolio to include haemophilia A.
Haemophilia A is a genetic disorder caused by insufficient or defective factor VIII, a blood-clotting protein. It represents 80% of haemophilia cases worldwide, according to the companies.
mAbxience CEO Jurgen Van Broeck said: “This agreement with Sandoz represents a significant recognition of mAbxience’s development and manufacturing platform and the expertise of our teams.
“This agreement combines our capabilities with Sandoz’s global biosimilars reach and provides a clear pathway to broaden access to treatment for patients living with haemophilia A.
“It also reinforces our strategy of combining world-class development and manufacturing capabilities with selected commercial partnerships that can help accelerate patient access to high-quality biologic medicines worldwide.”
Based in Spain, mAbxience is majority-owned by Fresenius Kabi, with Insud Pharma holding a partial stake. The company develops, produces and commercialises biopharmaceuticals.
The company has three approved products and operates in more than 100 markets via a business-to-business model. It has over 40 partners and more than 1,300 employees.
Its biosimilar pipeline includes products across bone diseases, immunology, oncology and other speciality care areas. mAbxience also provides contract development and manufacturing services.
Last month, Sandoz entered a collaboration agreement with Shanghai Henlius Biotech to work on new biosimilars.