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Novartis intends to transition Arzerra to limited availability in non-US markets.

M2 PHARMA-January 22, 2018-Novartis intends to transition Arzerra to limited availability in non-US markets


Novartis (VTX: NOVN) has revealed its intention to transition Arzerra (ofatumumab), a treatment for certain chronic lymphocytic leukaemia (CLL) indications, from commercial availability to limited availability via compassionate use programmes in all markets except the United States, Genmab A/S (CPH: GEN) announced on Monday.

To ensure continuity of treatment for all patients benefiting from Arzerra, Novartis will work with regulatory authorities to establish compassionate use programmes for those currently receiving the treatment outside the US.

"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," explained Jan van de Winkel, CEO of Genmab.

As a result of the company's decision, Novartis will pay Genmab a total of USD50m to cover lost potential milestones and royalties, as Arzerra is marketed under a collaboration agreement the two companies. Royalties will continue to be earned on net sales of Arzerra.

The intention is to start the transition process as soon as the various regulatory authorities have agreed on a carefully structured plan.

The company will continue its ongoing Phase III studies of ofatumumab in Relapsing Multiple Sclerosis and in indolent non-Hodgkin lymphoma.

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Publication:M2 Pharma
Date:Jan 22, 2018
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