Biogen Exercises Option to Participate in the Development & Commercialization of a Late-Stage Bispecific Antibody

Biogen Inc. recently announced it exercised its option to participate in the development and commercialization of mosunetuzumab. Biogen will pay a $30-million one-time option fee to Genentech, a member of the Roche Group, as part of the companies’ long-standing collaboration on antibodies targeting CD20.

Mosunetuzumab is a CD20xCD3 T-cell engaging bispecific antibody in development for the treatment of people with B-cell non-Hodgkin’s lymphoma (NHL), including follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). In June 2020, mosunetuzumab was granted Breakthrough Therapy Designation (BTD) by the US FDA for the treatment of adult patients with relapsed/refractory (R/R) FL who have received at least two prior systemic therapies.

Genentech plans to complete a Biologics License Application (BLA) submission to the FDA in the near future for approval consideration from the GO29781 study investigating mosunetuzumab in patients with R/R FL. If approved, mosunetuzumab has the potential to be a first-in-class CD20xCD3 T-cell engaging bispecific antibody in NHL. Roche recently submitted the initial marketing authorization application for mosunetuzumab to the European Medicines Agency (EMA), with the hope to bring this drug as soon as possible to people with NHL. In addition, mosunetuzumab recently began a Phase 1b trial in patients with systemic lupus erythematosus.

As a part of the option exercise, Biogen will pay a $30 million one-time option fee to Genentech and will pay for a portion of the mosunetuzumab development expenses incurred during 2021. Biogen will have joint decision-making rights related to development and commercialization of mosunetuzumab and Genentech will continue to lead the strategy and implementation of the program.

Biogen will share in the operating profits and losses of mosunetuzumab in US in the low to mid 30% range and is eligible to receive low single-digit royalties on sales outside the US.

As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing the industry’s most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil fuels across the company’s operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities. For more information, visit www.biogen.com.