* Transaction to include felzartamab, a potential first-in-class therapeutic

    candidate with promise as a pipeline-in-a-product across a range of immune-
    mediated diseases
  * Felzartamab is an investigational anti-CD38 monoclonal antibody that,
    through its cell depletion approach, has demonstrated clinical proof of
    concept in rare immune-mediated indications, with plans to advance to Phase
    3
  * Proposed acquisition builds on Biogen capabilities in immunology with plans
    to combine Human Immunology Biosciences expertise in immune-mediated
    indications with Biogen's global development and commercial experience in
    rare diseases

CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif., May 22, 2024 (GLOBE NEWSWIRE)
-- Biogen (http://www.biogen.com) Inc. (Nasdaq: BIIB) and 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), today announced the companies have entered into a definitive agreement
under which Biogen has agreed to acquire HI-Bio for $1.15 billion upfront and up
to $650 million in potential milestone payments.
HI-Bio's lead asset, felzartamab, is a fully human anti-CD38 monoclonal antibody
that has been shown in clinical studies to selectively deplete CD38+ cells
including plasma cells and natural killer, or NK, cells which may allow for
additional applications that improve clinical outcomes in a broad range of
immune-mediated diseases.
Felzartamab has received Breakthrough Therapy Designation (BTD) and Orphan Drug
Designation (ODD) from the U.S. Food and Drug Administration (FDA) for
development in the treatment of primary membranous nephropathy (PMN) and has
received ODD in the treatment of antibody-mediated rejection (AMR) in kidney
transplant recipients. Phase 2 studies have been completed in PMN and AMR and
remain ongoing in IgA nephropathy (IgAN), and HI-Bio has plans to advance each
indication to Phase 3. HI-Bio plans to present (https://hibio.com/news/hi-bio-
to-present-at-the-61st-european-renal-association-era-congress) two abstracts at
the upcoming European Renal Association (ERA) Congress in Stockholm, including
the complete Phase 2 data from the AMR study in kidney transplant patients and
interim data from the Phase 2 IgAN study. Felzartamab has clinical data in AMR,
PMN and IgAN indications.
"We believe this late-stage asset, which has demonstrated impact on key
biomarkers and clinical endpoints in three renal diseases with serious unmet
needs, is a strategic addition to the Biogen portfolio as we continue to augment
our pipeline and build on our expertise in immunology," said Priya Singhal,
M.D., M.P.H., Head of Development at Biogen. "We look forward to welcoming HI-
Bio employees into Biogen and, together, working to advance potential therapies
for patients with rare immune diseases with high unmet need."
"With its deep development and commercialization capabilities, Biogen is in a
position to accelerate the development of new medicines, including felzartamab,
for patients with severe immune-mediated diseases," said Travis Murdoch, M.D.,
Chief Executive Officer of HI-Bio. "We are excited to combine the HI-Bio team's
expertise with Biogen's global footprint."
Biogen plans to leverage its existing global development and commercialization
capabilities in rare disease and its strong scientific expertise in immunology
to support the advancement of felzartamab and the HI-Bio pipeline. Biogen seeks
to retain expertise and talent from HI-Bio and establish a San Francisco Bay
Area team focused on expanding our efforts in immune-mediated diseases.
In addition to lead program felzartamab, the HI-Bio pipeline includes
izastobart/HIB210, an anti-C5aR1 antibody currently in a Phase 1 trial and with
potential for continued development in a range of complement-mediated diseases.
HI-Bio also has discovery stage mast cell programs with potential in a range of
immune-mediated diseases.
Financial Details and Terms of the Transaction
Under the terms of the agreement, Biogen will make an upfront payment to HI-Bio
of $1.15 billion. HI-Bio's stockholders would also be eligible for payments of
up to an additional $650 million, for a total potential deal value of up to $1.8
billion, should the felzartamab programs achieve certain development milestones.
The acquisition of HI-Bio is not expected to impact Biogen's previously issued
2024 guidance. Biogen expects to finance the acquisition with cash and may also
draw on its revolving credit agreement. The transaction is subject to customary
closing conditions, including receipt of necessary regulatory approvals and is
currently anticipated to close in the third quarter of 2024.
Advisors
Covington & Burling LLP acted as legal advisor to Biogen. Goldman Sachs & Co.
LLC and BofA Securities, Inc. acted as financial advisors to HI-Bio and Goodwin
Procter LLP acted as its legal advisor.
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.
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
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 -
Facebook (https://www.facebook.com/Biogen/), LinkedIn
(https://www.linkedin.com/company/biogen-/), X (https://twitter.com/biogen),
YouTube (https://www.youtube.com/c/biogen).
About HI-Bio
Human Immunology Biosciences, Inc. (HI-Bio(TM)), was incubated by ARCH Venture
Partners and Monograph Capital to develop precision therapies for immune-
mediated diseases and to bring clinical immunology into its next chapter.
Inspired by the rise of targeted therapies in clinical oncology, the company
pursues a therapeutic strategy of targeting and depleting the immune cell types
that drive IMDs. The company's most advanced candidate, felzartamab, is a CD38-
targeted antibody shown in clinical studies to deplete CD38+ cells, including
plasma and natural killer (NK) cells, which are implicated in a range of
indications including antibody-mediated rejection (AMR), IgA nephropathy (IgAN),
lupus nephritis (LN) and primary membranous nephropathy (PMN). Other investors
include Alpha Wave Global, Arkin Bio Capital, Jeito Capital and Viking Global
Investors.
To learn more about HI-Bio, visit www.hibio.com (http://www.hibio.com) or follow
the company on LinkedIn (https://www.linkedin.com/company/hibio)and X
(https://x.com/HIBiosciences).
Biogen Safe Harbor
This press release contains forward-looking statements, relating to: our and HI-
Bio's ability to complete the proposed transaction, and the expected timing of
such completion; 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
 MEDIA CONTACTS:                           INVESTOR CONTACT:
 Biogen                                    Biogen
 Jack Cox                                  Chuck Triano
 + 1 781 464 3260                          +1 781 464 2442
 public.affairs@biogen.com                 IR@biogen.com (mailto:IR@biogen.com)

(mailto:public.affairs@biogen.com)
HI-Bio
Morgan Warners
morgan.warners@fgsglobal.com
(mailto:morgan.warners@fgsglobal.com)
Rich Allan
rich.allan@fgsglobal.com
(mailto:rich.allan@fgsglobal.com)
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