Prima cijfers, in lijn der verwachting. Wel flinke enmalige post ivm afwikkelen van destijds gestopte phase 3 onderzoek ofatumumab. Verder geen spectakel. Gewoon doorontwikkelen. Verkoop Darzalex loopt ook prima, waardoor al eerder de outlook was verhoogd. Aandeel doorbrak gisteren zijn alltime high. Veel vertrouwen in het aandeel en altijd ergens op de achtergrond de mogelijke belangstelling van een big pharma voor dit snoepje...
May 10, 2016; Copenhagen, Denmark;
Interim Report for the First Quarter of 2016
Net Sales of DARZALEX® (daratumumab) by Janssen for the first quarter of 2016 were USD 101.9 million, resulting in royalty income of DKK 83 million
Announced positive interim result in Phase III Castor study of daratumumab in relapsed or refractory multiple myeloma
Announced studies of daratumumab in combination with atezolizumab in a solid tumor and multiple myeloma
Achieved USD 5 million milestone for progress in the Phase II study of daratumumab in non-Hodgkin's lymphoma (NHL) under collaboration with Janssen
Announced updated development plans for ofatumumab in autoimmune indications
U.S. Food and Drug Administration (FDA) Approval of Arzerra® (ofatumumab) as extended treatment for recurrent or progressive chronic lymphocytic leukemia (CLL)
U.S. and EU regulatory submissions for ofatumumab in combination with fludarabine and cyclophosphamide for relapsed CLL
"The first quarter of 2016 saw continued rapid progress in the development of daratumumab with Janssen: We reported positive interim data in the Phase III Castor study of daratumumab in combination with bortezomib and dexamethasone, achieved the second milestone in the Phase II NHL study, and announced the first study to combine daratumumab with Roche's anti-PDL1 antibody atezolizumab, in a solid tumor and multiple myeloma. We also started off the year with a number of achievements under our Arzerra collaboration with Novartis. Arzerra was approved in the U.S. as extended treatment for recurrent or progressive CLL and regulatory submissions for ofatumumab in combination with fludarabine and cyclophosamide in relapsed CLL were submitted in the U.S. and Europe. Furthermore, we announced that development of the subcutaneous formulation of ofatumumab in autoimmune indications will be focused on relapsing multiple sclerosis, with large Phase III studies run by Novartis expected to start later this year," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.