Novartis plans to transition the use of its treatment for certain chronic lymphocytic leukaemia (CLL), Arzerra (ofatumumab), from commercial availability to limited availability via compassionate use programmes in all markets except the US.
As a result of this decision by Novartis, the company will pay a lump sum of $50 million to Genmab for potential lost milestone payments and royalties. This lump sum payment will be included in Genmab’s year guidance to be issued in February and royalties will be paid on net sales of Arzerra.
“Novartis’ intention to transition Arzerra to compassionate use programmes in the non-US markets reflects the fact that many more drugs have become available for CLL over the last five years and that there is a low number of patients using Arzerra outside of the US market. The compassionate use programmes will ensure that patients who benefit from Arzerra can remain on treatment. We welcome the continued commercial availability of Arzerra for US patients,” said Jan van de Winkel, PhD, chief executive officer of Genmab.
In order to establish compassionate use programmes for patients outside of the US, Novartis will work with regulatory. Through this work, patients who are currently being treated with Arzerra will be able to continue treatment as long as they benefit from it and will be offered treatment free-of-charge.
The transition process will start as soon as a carefully structured plan has been agreed with the relevant regulatory authorities.