Biogen Completes Acquisition of Human Immunology

CAMBRIDGE, Mass., July 2, 2024 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq BIIB) has completed the acquisition of Human Immunology Biosciences (HI-Bio™), a privately held, clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMD).

“We are very excited to add felzartamab to our portfolio, further strengthening our presence in immunology with a promising late-stage therapeutic candidate that is being studied in multiple indications,” said Priya Singhal, MD, MPH, Head of Development at Biogen. “Upon completion of the transaction, we will begin working with our colleagues at HI-Bio on plans to advance felzartamab to Phase 3 and ultimately deliver innovative treatments to patients with unmet needs across multiple rare diseases.”

“I look forward to the important progress HI-Bio will make as part of Biogen, and the power of combining our talented HI-Bio team with Biogen’s global infrastructure to support the development of felzartamab and accelerate Biogen’s expanding immunology portfolio,” said Travis Murdoch, MD, CEO of HI-Bio. “From our engagement over many months — as we considered how HI-Bio’s programs could best advance — it is clear that our teams share many of the same values, including a commitment to science and execution and a core mission to positively impact patients with serious diseases.”

Felzartamab has shown positive interim results from a phase 2 study in IgA nephropathy (IgAN) and from a completed phase 2 study in antibody-mediated rejection (AMR). These data were presented at the recent European Society of Nephrology Congress in Stockholm. Data from the AMR study were also published in the New England Journal of Medicine. Felzartamab has also shown proof of concept in a phase 2 study in primary membranous nephropathy (PMN), and there are plans to advance felzartamab to phase 3 in AMR, IgAN, and PMN.

About Felzartamab
Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Clinical studies have shown that felzartamab selectively depletes CD38+ plasma cells, which may enable applications that will ultimately improve clinical outcomes in a wide range of pathogenic antibody-mediated diseases. Felzartamab was originally developed by MorphoSys AG for multiple myeloma. HI-Bio has obtained an exclusive license for the rights to develop and commercialize felzartamab for all indications in all countries and territories excluding China (including Macau, Hong Kong, and Taiwan).

Felzartamab is an investigational drug candidate that has not yet been approved by any regulatory authority, and its safety and effectiveness have not been confirmed.

On antibody-mediated rejection (AMR) in kidney transplant recipients
Antibody-mediated rejection (AMR) is a leading cause of kidney transplant failure, with chronic AMR affecting approximately 12% of kidney transplant recipients per year in the United States.¹ AMR has become a leading cause of late graft loss in renal transplant recipients. Effective treatment options for chronic AMR are currently limited.²

About Primary Membranous Nephropathy (PMN)
Primary membranous nephropathy (PMN) is a rare parenchymal renal disease with an estimated incidence of approximately 1/100,000 per year in the United States.³ There are currently no therapies approved specifically for PMN. The standard of care includes off-label use of various agents, including immunosuppressive therapies such as cyclophosphamide and B-cell depleting agents targeting CD20 such as rituximab.⁴ Despite these strategies, approximately one third of patients fail to achieve remission.⁴

About IgA nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is the most common primary glomerular kidney disease worldwide. It is a leading cause of chronic kidney disease, with up to 40% of patients with IgAN developing end-stage renal disease approximately 20 years after diagnosis. IgAN accounts for approximately 40% of all native kidney biopsies in Japan, 25% in Europe, 12% in the United States, but less than 5% in Central Africa.⁵

About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines that transform the lives of patients and create value for shareholders and our communities. We apply a deep understanding of human biology and leverage multiple modalities to develop best-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment, to deliver long-term growth.

We routinely publish information that may be important to investors on our website at www.biogen.com. Follow us on social media – Facebook, LinkedIn, X, YouTube.

Biogen Safe Haven
This press release contains forward-looking statements regarding: the expected and potential benefits of the acquisition of HI-Bio, including with respect to customer retention; the potential for the felzartamab program and other HI-Bio programs within the program and matters related thereto; the expected financing of the proposed acquisition; the costs and other expected financial effects of the proposed transaction; our strategy and plans; our clinical development programs, clinical trials and data readouts and presentations; regulatory discussions, applications, submissions and approvals; the potential benefits, safety and effectiveness of our investigational products and therapies; activities to expand our program, collaborations and business development activities; and our future financial and operating results. These forward-looking statements may be supplemented by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “project,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “outlook,” “will,” “could” and other similar words and terms. The development and commercialization of drugs involves a high degree of risk, and only a small number of R&D programs result in commercialization of a product. Results from early clinical trials may not be indicative of full results or the results of subsequent clinical trials or larger studies and do not guarantee regulatory approval. You should not place undue reliance on these statements. All forward-looking statements contained in this press release speak only as of the date hereof and, except to the extent required by law, we do not undertake any obligation to publicly update or revise any forward-looking statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements, including: the impact of the announcement and suspension of the acquisition on HI-Bio’s business, including its relationships with its employees, business partners and governmental entities; uncertainty regarding the timing and completion of the merger; the risk that any required regulatory approval or other condition to closing may not be satisfied; the expenditure of management’s time on matters related to the transaction; the costs and potential litigation, settlements and investigations related to the proposed merger; the ability to retain management and other personnel; our dependence on sales of our products; uncertainty regarding long-term success in developing, licensing or acquiring other product candidates or additional indications for existing products; the lack of effective competition; the failure to successfully realize or realize the anticipated benefits of the acquisition or our strategic and development initiatives; difficulties in obtaining and maintaining adequate coverage, pricing and reimbursement for our products; our dependence on collaborators and other third parties for the development, regulatory approval and commercialization of products and other aspects of our business that are beyond our full control; risks related to current and potential future healthcare reforms; risks related to the commercialization of biosimilars; failure to obtain, protect and enforce our data, intellectual property rights and other proprietary rights; and risks and uncertainties related to intellectual property claims and challenges; the risk that positive results from a clinical trial may not be replicated in subsequent or confirmatory trials or success in early phase clinical trials may not be predictive of results in later stage or large-scale clinical trials or trials in other potential indications; risks related to clinical trials, including the ability to appropriately manage clinical activities, unexpected concerns that may arise from additional data or analyses obtained during clinical trials, or that regulatory authorities may require additional information or further studies, or may not approve or delay approval of our or HI-Bio’s drug candidates; the occurrence of adverse safety events, restrictions on the use of our products or product liability claims; risks related to technology failures or breaches; problems with our manufacturing processes; risks related to management, personnel and other organizational changes, including the attraction and retention of personnel; failure to meet legal and regulatory requirements; risks related to doing business internationally, including currency fluctuations; risks related to investments in our manufacturing capabilities; risks related to third parties distributing and selling counterfeit or inappropriate versions of our products; risks related to the use of social media and artificial intelligence software in our business; operating results and financial condition; fluctuations in our operating results; risks related to investing in real estate; risks related to access to capital and credit markets; risks related to debt; market, interest and credit risks related to our investment portfolio; risks related to stock repurchase programs; changes in the control provisions in certain of our cooperation agreements; fluctuations in our effective tax rate; environmental risks; and any other risks and uncertainties described in other reports we file with the U.S. Securities and Exchange Commission.

Bibliography:

Schinstock et al. (2018) Kidney transplantation with low DSA or low positive B-flow crossmatch: an underestimated option for highly sensitive transplant candidates (page 8). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481511/pdf/nihms837168.pdf#page=8 ; Ciancio et al. 2018 Antibody-mediated rejection signifies poor prognosis in kidney transplantation: results from a single center. Available at: https://onlinelibrary.wiley.com/doi/10.1111/ctr.13392
Rodriguez-Ramirez et al. 2022 Antibody-mediated rejection: prevention, monitoring, and treatment dilemmas (page 1). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9475491/
Swaminathan et al. (2006) Changing incidence of glomerular kidney disease in Olmsted County, Minnesota: a 30-year renal biopsy study. Available at https://pubmed.ncbi.nlm.nih.gov/17699249/
Dahan et al. (2017) Rituximab in the treatment of severe membranous nephropathy: a 6-month study with extended follow-up. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5198292/
Rajasekaran et al. (2021) IgA nephropathy: an interesting autoimmune kidney disease. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5198292/. Hastings et al. (2018) Clinical studies, life expectancy of patients from the southeastern United States with IgA nephropathy. Available at https://www.kireports.org/article/S2468-0249(17)30362-5/fulltext