- Novartis intends to transition availability of Arzerra® (ofatumumab) to an oncology access program for chronic lymphocytic leukemia patients in the U.S.
- Genmab receives USD 30 million from Novartis as payment for lost potential royalties and improves 2020 financial guidance
COPENHAGEN, Denmark I August 20, 2020 I Genmab A/S (Nasdaq: GMAB) announced today 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. 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.
“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.
About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX® (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta® (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA® (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra® (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab’s technology base consists of validated and proprietary next generation antibody technologies – the DuoBody® platform for generation of bispecific antibodies, the HexaBody® platform, which creates effector function enhanced antibodies, the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
SOURCE: Genmab
Post Views: 21
- Novartis intends to transition availability of Arzerra® (ofatumumab) to an oncology access program for chronic lymphocytic leukemia patients in the U.S.
- Genmab receives USD 30 million from Novartis as payment for lost potential royalties and improves 2020 financial guidance
COPENHAGEN, Denmark I August 20, 2020 I Genmab A/S (Nasdaq: GMAB) announced today 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. 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.
“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.
About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX® (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta® (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA® (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra® (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab’s technology base consists of validated and proprietary next generation antibody technologies – the DuoBody® platform for generation of bispecific antibodies, the HexaBody® platform, which creates effector function enhanced antibodies, the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
SOURCE: Genmab
Post Views: 21
