On August 20, 2020 Genmab A/S (Nasdaq: GMAB) reported that Novartis intends to transition availability of Arzerra (ofatumumab) to an oncology patient access program that will provide Arzerra at no cost to chronic lymphocytic leukemia (CLL) patients in the U.S (Press release, Genmab, AUG 20, 2020, View Source [SID1234563901]). This program will be facilitated through the Patient Access Novartis Oncology (PANO). As a consequence, Novartis will pay Genmab a lump sum of USD 30 million as payment for lost potential royalties. Arzerra was developed by Novartis under a license agreement between Genmab and Novartis Pharma AG.
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"We are pleased that patients with CLL who have benefitted from Arzerra can remain on treatment via Novartis’ patient access program," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Genmab is also improving its 2020 financial guidance last published on August 12, 2020, due to the inclusion of the payment from Novartis.
OUTLOOK
MDKK Revised Guidance Previous
Guidance
Revenue 9,250 – 9,850 9,100 – 9,700
Operating expenses (3,850) – (3,950) (3,850) – (3,950)
Operating income 5,350 – 5,950 5,200 – 5,800
About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of normal B lymphocytes and on B cell malignancies (including chronic lymphocytic leukemia).
In more than 60 countries worldwide, including the United States and EU member countries, Arzerra was approved as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab. In the United States, Arzerra was also 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 combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL, for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL and as monotherapy for the treatment of patients with CLL refractory to fludarabine and alemtuzumab. In the European Union, Arzerra was 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 and in combination with fludarabine and cyclophosphamide for adult patients with relapsed CLL. On January 22, 2018, it was announced that Novartis would transition Arzerra for the treatment of CLL indications from commercial availability to limited availability via compassionate use programs in markets outside of the U.S. and Japan. Subsequently, on August 7, 2020, it was announced that Novartis would transition availability of Arzerra in the U.S. to an oncology access program. Novartis obtained rights for ofatumumab from Genmab in all indications in December 2015.