On December 21, 2015 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the agreement under which GlaxoSmithKline (GSK) grants Novartis Pharma AG (Novartis) the remaining rights to ofatumumab, including rights in autoimmune diseases, is now effective (Press release, Genmab, DEC 21, 2015, View Source [SID:1234508619]). Schedule your 30 min Free 1stOncology Demo! The agreement was announced in August 2015 and was subject to certain closing conditions, which have now been met. Novartis will be responsible for the development and commercialization of ofatumumab for all indications going forward.
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"We are pleased with our existing collaboration with Novartis within the cancer field, and are looking forward to working with Novartis on ofatumumab for all remaining indications, including autoimmune diseases. We are looking forward to the initiation of clinical studies evaluating the subcutaneous formulation of ofatumumab as a potential therapy for patients with various autoimmune disorders," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.
In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.
Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).
Arzerra is marketed under a collaboration agreement between Genmab and Novartis.