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 (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 RecipientsAntibody-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 BiogenFounded 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. Follow us on social
media - Facebook, LinkedIn, X, YouTube.
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:
- 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#page=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
- 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
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 for Severe Membranous
Nephropathy: A 6-Month Trial 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 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
|
|
MEDIA
CONTACTS:BiogenJack Cox+ 1 781 464
3260public.affairs@biogen.com |
INVESTOR
CONTACT:BiogenChuck Triano+1 781 464
2442IR@biogen.com |
Grafico Azioni Biogen (NASDAQ:BIIB)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni Biogen (NASDAQ:BIIB)
Storico
Da Dic 2023 a Dic 2024