Biogen Inc. (BIIB, Financial) announced on Thursday that it has entered into an agreement that will see Samsung BioLogics (XKRX:207940, Financial) acquire Biogen’s equity stake in the Samsung Bioepis joint venture for an aggregate consideration of up to $2.3 billion. The cash injection should help Biogen reach important research goals, such as the next phase in clinical trials for its controversial Alzheimer's treamtent, Aduhelm.
The joint venture
A pioneer in neuroscience, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. Samsung BioLogics provides contract development and manufacturing services for companies in the biopharmaceutical industry.
Biogen and Samsung BioLogics have built the industry leading anti-TNF portfolio in Europe. Upon the acquisition of Biogen’s stake, the companies will continue with their exclusive agreements, including commercialization of their current portfolio. This includes marketed products Benepali (etanercept), a biosimilar referencing Enbrel, Imralditm (adalimumab), a biosimilar referencing Humira and Flixabi (infliximab), a biosimilar referencing Remicade. Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they can offer significant cost savings and increased patient access.
Additionally, Biogen will also retain commercial rights for Byooviztm (ranibizumab-nuna), an approved biosimilar referencing Lucentis (ranibizumab), as well as an investigational biosimilar candidate in development, SB15 (aflibercept), a proposed biosimilar referencing Eylea.
“We are thankful to Samsung BioLogics for a productive collaboration since 2012,” said Michel Vounatsos, CEO of Biogen, in a statement. “We believe biosimilars are essential to help sustain healthcare systems and represent an important value creation opportunity for Biogen.”
Samsung BioLogics has agreed to pay Biogen up to $2.3 billion for its stake in the joint venture. Under the terms of this agreement, Biogen will receive $1 billion in cash at closing and $1.25 billion to be deferred over two payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction.
Biogen is eligible to receive up to $50 million contingent upon achievement of certain commercial milestones. Closing of the transaction is contingent on the effectiveness of a securities registration statement filed by Samsung BioLogics and satisfaction of certain regulatory and other customary closing conditions. Upon closing, Biogen will recognize a GAAP gain on disposal within other income, net in its consolidated statement of income.
Diversifying Aduhelm trials
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.
Following up on this committment, Biogen and Tokyo, Japan-based Eisai Co. Ltd. (TSE:4523, Financial) announced additional details about the Phase 4 post-marketing confirmatory study of Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease, including details of the study’s goal for diverse enrollment and primary endpoint.
Biogen aims to enroll 18% of U.S. participants in the study, called Envision, from Black/African American and Latinx populations, the company said in a release. This goal is reflective of Biogen’s ongoing commitment to increase diversity in clinical trials.
“Historically, patients from diverse backgrounds have been poorly represented in Alzheimer’s disease clinical trials, and we are committed to changing this,” said Priya Singhal M.D., M.P.H., Head of Global Safety and Regulatory Sciences and interim Head of Research and Development at Biogen, in a statement. “This goal matches the diversity among Americans diagnosed with early Alzheimer’s disease, while at the same time, the trial will generate substantial data to verify the effectiveness of ADUHELM.”
Biogen will implement multiple strategies to help overcome barriers to diverse patient enrollment in Alzheimer’s disease trials, such as lack of access to medical centers, familiarity with benefit/risk profile of treatment and financial or logistical burdens.
