CAMBRIDGE, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Biogen Inc.
(http://www.biogen.com) (Nasdaq: BIIB) has completed the acquisition of Human
Immunology Biosciences (HI-Bio(TM)), a privately-held clinical-stage biotechnology
company focused on targeted therapies for patients with severe immune-mediated
diseases (IMDs).
"We are very excited about the addition of felzartamab into our pipeline,
further strengthening our presence in immunology with a promising late-stage
therapeutic candidate being studied in multiple indications," said Priya
Singhal, M.D., M.P.H., Head of Development at Biogen. "With the transaction now
complete, we will begin working together with our colleagues from HI-Bio on
plans to advance felzartamab to phase 3 and ultimately deliver innovative
treatments to patients with unmet needs across a range of rare diseases."
"I'm looking 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, M.D., CEO of HI-Bio. "It's
clear from our engagement over many months - as we considered how HI-Bio
programs could progress in the best possible way - that our teams share many of
the same values, including being science-led and execution-focused, and a core
mission to positively impact patients with severe diseases."
Felzartamab demonstrated positive interim results from the Phase 2 IgA
nephropathy (IgAN) study and from the completed Phase 2 antibody-mediated
rejection (AMR) study. These data were presented at the recent European Renal
Association Congress in Stockholm. The AMR study data were also published in the
New England Journal of Medicine. Felzartamab has also demonstrated 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. Felzartamab has been
shown in clinical studies to selectively deplete CD38+ plasma cells, which may
allow applications that ultimately improve clinical outcomes in a broad range of
diseases driven by pathogenic antibodies. Felzartamab was originally developed
by MorphoSys AG for multiple myeloma. HI-Bio exclusively licensed the rights to
develop and commercialize felzartamab across all indications in all countries
and territories excluding China (including Macau and Hong Kong and Taiwan).
Felzartamab is an investigational therapeutic candidate that has not yet been
approved by any regulatory authority and its safety and effectiveness have not
been established.
About Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients
Antibody-mediated rejection (AMR) is a major cause of kidney transplant failure,
with chronic AMR affecting -12% of patients that receive kidney transplants
annually in the U.S.(1) AMR has emerged as the leading cause of late graft loss
in kidney transplant recipients. Effective treatment options for chronic AMR are
currently limited.(2)
About Primary Membranous Nephropathy (PMN)
Primary membranous nephropathy (PMN) is a rare IMD affecting the kidneys, with
an estimated incidence rate of -1/100K per year in the United States.(3) There
are currently no therapies specifically approved for PMN. Standard of care
comprises off-label use of a variety of agents, including immunosuppressive
therapies like cyclophosphamide, and CD20-targeted B-cell depleting agents such
as rituximab.(4) Even with these strategies, approximately one third of patients
do not achieve remission.(4)
About IgA Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is the most common primary
glomerulonephritis worldwide. It is a leading cause of chronic kidney disease
with up to 40% of IgAN patients progressing to end stage kidney disease about
20 years after diagnosis. IgAN accounts for about 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 to transform patients' lives and to
create value for shareholders and our communities. We apply deep understanding
of human biology and leverage different modalities to advance first-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 post information that may be important to investors on our website
at www.biogen.com (https://www.biogen.com/). Follow us on social media -
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(https://www.linkedin.com/company/biogen-/), X (https://twitter.com/biogen),
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Biogen Safe Harbor
This press release contains forward-looking statements, relating to: the
anticipated and potential benefits of the acquisition of HI-Bio; including with
respect to retention; the potential of, and relating to, the felzartamab program
and HI-Bio's other pipeline programs; expected financing of the proposed
acquisition; costs and other anticipated financial impacts of the proposed
transaction; our strategy and plans; clinical development programs, clinical
trials, and data readouts and presentations; regulatory discussions,
submissions, filings, and approvals; the potential benefits, safety, and
efficacy of products and investigational therapies; actions to augment our
pipeline, collaborations, and business development activities; and our future
financial and operating results. These forward-looking statements may be
accompanied by such words as "aim," "anticipate," "believe," "could,"
"estimate," "expect," "forecast," "goal," "intend," "may," "plan," "potential,"
"possible," "prospect," "will," "would," and other words and terms of similar
meaning. Drug development and commercialization involve a high degree of risk,
and only a small number of research and development programs result in
commercialization of a product. Results in early-stage clinical trials may not
be indicative of full results or results from later stage or larger scale
clinical trials and do not ensure 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 made and, except to the extent
required by law, we undertake no 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 reflected in such statements, including: the
impact of the announcement and pendency of the acquisition on HI-Bio's business,
including on relationships with its employees, business partners and government
entities; uncertainties as to the timing and completion of the merger; the risk
that required regulatory approval or other condition to closing may not be
satisfied; the diversion of management time on transaction-related issues; costs
and potential litigation, settlements and investigations relating to the
proposed merger; the ability to retain management and other personnel; our
dependence on sales from our products; uncertainty of long-term success in
developing, licensing, or acquiring other product candidates or additional
indications for existing products; failure to compete effectively; failure to
successfully execute or realize the anticipated benefits of the acquisition or
our strategic and growth 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,
which are outside of our full control; risks associated with current and
potential future healthcare reforms; risks related to commercialization of
biosimilars; failure to obtain, protect, and enforce our data, intellectual
property, and other proprietary rights and the risks and uncertainties relating
to intellectual property claims and challenges; the risk that positive results
in a clinical trial may not be replicated in subsequent or confirmatory trials
or success in early stage clinical trials may not be predictive of results in
later stage or large scale clinical trials or trials in other potential
indications; risks associated with clinical trials, including the ability to
adequately manage clinical activities, unexpected concerns that may arise from
additional data or analysis obtained during clinical trials, or that regulatory
authorities may require additional information or further studies, or may fail
to approve or may delay approval of our or HI-Bio's drug candidates; the
occurrence of adverse safety events, restrictions on use with our products, or
product liability claims; risks relating to technology failures or breaches;
problems with our manufacturing processes; risks relating to management,
personnel and other organizational changes, including attracting and retaining
personnel; failure to comply with legal and regulatory requirements; the risks
of doing business internationally, including currency exchange rate
fluctuations; risks relating to investment in our manufacturing capacity; risks
relating to the distribution and sale by third parties of counterfeit or unfit
versions of our products; risks relating to the use of social media and
artificial intelligence based software for our business; results of operations,
and financial condition; fluctuations in our operating results; risks related to
investment in properties; risks relating to access to capital and credit
markets; risks related to indebtedness; the market, interest, and credit risks
associated with our investment portfolio; risks relating to share repurchase
programs; change in control provisions in certain of our collaboration
agreements; fluctuations in our effective tax rate; environmental risks; and any
other risks and uncertainties that are described in other reports we have filed
with the U.S. Securities and Exchange Commission.
References:
1. Schinstock et al. (2018) Kidney Transplant with Low Levels of DSA or Low
Positive B-Flow Crossmatch: An Underappreciated Option for Highly-Sensitized Transplant Candidates (Page 8). Available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481511/pdf/nihms837168.pdf#pag e=8 ; Ciancio et al. 2018 Antibody-Mediated Rejection Implies a Poor
Prognosis in Kidney Transplantation: Results From a Single Center. Available at: https://onlinelibrary.wiley.com/doi/10.1111/ctr.13392
2. 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/

3. Swaminathan et al. (2006) Changing incidence of glomerular disease in

    Olmsted County, Minnesota: a 30-year renal biopsy study. Available at
    https://pubmed.ncbi.nlm.nih.gov/17699249/

4. Dahan et al. (2017) Rituximab for Severe Membranous Nephropathy: A 6-Month

    Trial with Extended Follow-Up. Available at
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5198292/

5. Rajasekaran et al. (2021) IgA nephropathy: An interesting autoimmune kidney
disease. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5198292/. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8577278/) Hastings et al
(2018) Clinical Research, Life Expectancy for Patients From the Southeastern

    United States With IgA Nephropathy. Available at
    https://www.kireports.org/article/S2468-0249(17)30362-5/fulltext
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