Sandoz expands biosimilar pipeline with mAbxience deal for haemophilia A treatment
The agreement covers licensing, development, manufacturing and commercialisation of the candidate, which is currently in the early stages of development.
SWITZERLAND—Sandoz and mAbxience have signed an agreement to develop, manufacture and commercialize a proposed biosimilar to emicizumab, a medicine used to prevent bleeding in people with haemophilia A.
The agreement covers licensing, development, manufacturing and commercialisation of the candidate, which is currently in the early stages of development.
The companies said the reference medicine, Hemlibra (emicizumab), generated estimated global sales of US$5.7 billion.
Development and manufacturing
Under the agreement, mAbxience will lead development and manufacturing of the proposed biosimilar at its Good Manufacturing Practice (GMP) approved facilities in Argentina and Spain.
Sandoz will hold exclusive global commercialisation rights to the candidate, except in Argentina, Paraguay and Uruguay.
The companies did not disclose the financial terms of the agreement.
The deal marks Sandoz’s entry into haemophilia through its biosimilar pipeline.
For mAbxience, it adds haemophilia A to its rare disease portfolio and builds on the company’s existing biologics development and manufacturing capabilities.
Focus on haemophilia A
Haemophilia A is an inherited bleeding disorder caused by insufficient or defective factor VIII, a protein required for normal blood clotting.
According to Sandoz and mAbxience, haemophilia A accounts for about 80% of haemophilia cases worldwide.
Emicizumab is a bispecific antibody that is used as a prophylactic treatment to help prevent bleeding episodes in people with haemophilia A.
The proposed biosimilar remains at an early development stage, and further development and regulatory processes will be required before it can reach markets.
Companies combine capabilities
Jürgen Van Broeck, CEO of mAbxience, said the agreement recognises the company’s development and manufacturing capabilities and the expertise of its teams.
He said the partnership brings together mAbxience’s development and manufacturing capabilities with Sandoz’s global biosimilars commercialisation network.
According to Van Broeck, the arrangement is intended to support broader access to biologic treatments for people living with haemophilia A.
He added that the agreement aligns with mAbxience’s strategy of combining its development and manufacturing capabilities with selected commercial partnerships.
Sandoz and mAbxience said the proposed collaboration will cover the development and manufacturing of the candidate by mAbxience and its commercialisation by Sandoz across the agreed territories.
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