- Published Articles Suggest the Global Market for Rituximab Biosimilars Could Potentially be over $1B Per Year
- Royalty Stream Relates to Agreement Acquired in Aptevo Spin-off from Emergent BioSolutions
Aptevo Therapeutics Inc., a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR bispecific technology platform, today announced that it will receive a royalty from Pfizer related to sales of a rituximab biosimilar product, RUXIENCE (Rituximab-pvvr), which was approved by the U.S. Food and Drug Administration in July 2019 and launched by Pfizer in the United States and Japan in early 2020.
"We are pleased to be receiving this first royalty payment from Pfizer and look forward to future quarterly payments, all of which will contribute non-dilutive funding to support our organization," said Marvin L. White, President and Chief Executive Officer. "This funding will help to support the advancement of our novel ADAPTIR bispecific antibody platform and more specifically, our lead ADAPTIR bispecific candidate, APVO436, which is progressing in a Phase 1/1b clinical study for the treatment of acute myeloid leukemia. Dosing in cohort 6 of the study is currently underway. We look forward to providing an update on this clinical program as additional data are available."
The payment from Pfizer relates to an agreement acquired by Aptevo as part of its spin-off from Emergent BioSolutions in 2016, which applies a fixed royalty rate in the low single digits on net sales in the United States, European Union, and Japan. The agreement was originally executed by Trubion Pharmaceuticals (which was subsequently acquired by Emergent BioSolutions Inc.,) and Wyeth (a wholly-owned subsidiary of Pfizer). The royalty term runs until the seventh anniversary of the first commercial sale of the CD20 biosimilar. Royalties payments to Aptevo are due within 60 days after the end of each quarter.
RUXIENCE is a biosimilar of Biogen's RITUXAN. In the US, RUXIENCE is approved for treatment of Non-Hodgkin's Lymphoma (alone or with other chemotherapy medicines), Chronic Lymphocytic Leukemia (with the chemotherapy medicines fludarabine and cyclophosphamide), and Granulomatosis with Polyangiitis and Microscopic Polyangiitis (with glucocorticoids). The product is also approved for use in Japan and received marketing authorization in the European Union in April 2020.
Additional information can be found in the Current Report on Form 8-K filed by Aptevo on June 25, 2020.
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for the treatment of cancer. The Company's lead clinical candidate, APVO436, and preclinical candidates, ALG.APV-527 and APVO603 were developed based on the Company's versatile and robust ADAPTIR modular protein technology platform. The ADAPTIR platform is capable of generating highly differentiated bispecific antibodies with unique mechanisms of action for the treatment of different types of cancer. For more information, visit www.aptevotherapeutics.com.