Seattle Genetics Achieves Milestone Following European Commission Approval of Roche’s Polivy® (Polatuzumab Vedotin)

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that it will receive a milestone payment from Roche triggered by European Commission conditional marketing authorisation for Polivy^® (polatuzumab vedotin). Polivy is an antibody-drug conjugate (ADC) that utilizes Seattle Genetics’ technology. It was developed and is commercialized by Roche/Genentech. Polivy was approved in combination with bendamustine plus MabThera^® (rituximab) (BR) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a haematopoietic stem cell transplant. Polivy was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of people with R/R DLBCL in 2017.

“In addition to our two marketed ADC products ADCETRIS^® (brentuximab vedotin) and the recently FDA-approved PADCEV^™ (enfortumab vedotin-ejfv), the European Commission approval of Polivy highlights the increasing importance of ADCs in the treatment of cancer,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Across our internal and collaborator pipelines, there are more than ten ADCs in clinical development employing our proprietary technology. We continue to lead in the field of ADCs with our novel linker systems, cell-killing payloads and conjugation technologies.”

Seattle Genetics’ ADC technology combines the specificity of monoclonal antibodies, innovative linker systems and potent cell-killing agents to treat cancer. The technology has been licensed to several companies, including Roche/Genentech and GlaxoSmithKline. Under the terms of these agreements, each licensee company has rights to use the technology with antibodies against specified targets. The licensee is responsible for research, product development, manufacturing and commercialization. Seattle Genetics is entitled to receive fees, progress-dependent milestone payments and royalties on worldwide net sales of any resulting ADC products.

About Seattle Genetics

Seattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative medicines targeting cancer to make a meaningful difference in people’s lives. ADCETRIS^® (brentuximab vedotin) and PADCEV^™ (enfortumab vedotin-ejfv) use the company’s industry-leading antibody-drug conjugate (ADC) technology designed to bring a powerful medicine directly to cancer cells. ADCETRIS is approved for the treatment of several types of CD30-expressing lymphomas, and PADCEV is approved to treat adults with metastatic urothelial cancer. In addition, investigational agent tucatinib, a small molecule tyrosine kinase inhibitor, is in late-stage development for HER2-positive metastatic breast cancer, and in clinical development for metastatic colorectal cancer. The company is headquartered in Bothell, Washington, and has offices in California, Switzerland and the European Union. For more information on our robust pipeline, visit www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

Forward-Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to anticipated milestone payments, fees, and royalties due to the company from Genentech and other licensees, the therapeutic uses of Polivy, the importance of ADCs in treating cancer and the company’s leadership in the field of ADCs. Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to factors such as unanticipated delays in or other obstacles to the development or commercialization of ADCs subject to these license agreements and the receipt by the Company of consideration from the subject ADC licenses. More information about the risks and uncertainties faced by the company is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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