SEATTLE, WA – Aptevo Therapeutics Inc. (NASDAQ:APVO), 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.
RUXIENCE is a trademark of Pfizer; RITUXAN is a trademark of Biogen.
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, please visit www.aptevotherapeutics.com
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding potential milestone payments, Aptevo’s outlook, financial performance or financial condition, estimated cash burn, Aptevo’s technology and related pipeline, collaboration and partnership opportunities, milestones, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will” and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause Aptevo’s actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo’s business or prospects; adverse developments in research and development; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in Aptevo’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as filed on March 25, 2020 and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo’s expectations in any forward-looking statement.