NM26 is a Phase 2-ready, first-in-class bispecific antibody
targeting two clinically proven pathways in atopic dermatitis
(AD)
The Company is leveraging a multi-pathway approach to transform
treatment in atopic dermatitis and other immune-mediated
diseases
Johnson & Johnson1 (NYSE: JNJ) announced today that it has
successfully completed the acquisition of Yellow Jersey, a demerged
subsidiary of Numab Therapeutics to secure the global rights to
NM26, a novel, investigational first-in-class bispecific antibody,
in an all-cash transaction of approximately $1.25 billion, as
announced on May 28, 2024.
NM26, which is ready to enter Phase 2 studies in atopic
dermatitis (AD), targets two clinically proven pathways, IL-4R
alpha subunit (IL-4Rα) and IL-31, which trigger Th2-mediated skin
inflammation and skin itch, respectively.
“NM26 is designed to help different subpopulations of patients
by targeting two disease-driving pathways, which is key when
treating a heterogeneous disease like AD,” said David Lee, Global
Immunology Therapeutic Area Head, Johnson & Johnson Innovative
Medicine. “We are excited about the potential this represents to
transform the standard of care for AD, as well as other
inflammatory skin diseases involving Th2 inflammation and
itch.”
AD is the most common inflammatory skin disease2. It causes
itching and inflammation which are made worse by scratching. It can
lead to increased risk of skin infections, skin pain, difficulty
sleeping, anxiety, stress, depression and even an increased risk of
suicide.
“Nearly three-quarters of people with AD are not achieving
remission with currently available treatments3. The unmet need is
high, and we must do better for patients,” said Candice Long,
Worldwide Vice President, Immunology, Johnson & Johnson. “Our
investment in NM26, and other bispecific antibodies, is another
important step towards our mission of durable, symptom-free
remission for all patients living with immune-mediated
diseases.”
1 Legal entity, Cilag Holding AG 2
https://pubmed.ncbi.nlm.nih.gov/27690741/ 3
https://pubmed.ncbi.nlm.nih.gov/27690741/
About Atopic Dermatitis
Atopic dermatitis (AD), also referred to as eczema, is a chronic
inflammatory skin disorder affecting more than 9.6 million children
and 16.5 million adults in the United States. AD is characterized
by an overactive immune system that causes damage to the skin
barrier, leaving it dry, itchy, and prone to rashes. AD may come
and go throughout life and patients can experience severe flares of
their disease. The condition can cause poor quality of life by
causing social stigma impacting the ability to interact with family
and friends, interrupting sleep due to intense itching and/or
painful skin, and leading to anxiety, stress and depression with an
increased risk of suicide.
About the agreement
Under the terms of the transaction Johnson & Johnson (the
Company) has acquired Yellow Jersey Therapeutics which includes the
NM26 program, and which was formed through a demerger with Numab.
J&J entered a separate agreement with Kaken Pharmaceutical to
secure rights in the Asia Pacific Region.
In accordance with US GAAP, the transaction is being accounted
for as an asset acquisition, resulting in an in-process research
and development charge of approximately $1.25B in the third quarter
of 2024 and full year Adjusted EPS dilution of $0.56 in 2024 and
approximately $0.10 in 2025. The 2024 impact will be reflected in
updated guidance at the second quarter earnings call on July 17,
2024.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our
strength in healthcare innovation empowers us to build a world
where complex diseases are prevented, treated, and cured, where
treatments are smarter and less invasive, and solutions are
personal. Through our expertise in Innovative Medicine and MedTech,
we are uniquely positioned to innovate across the full spectrum of
healthcare solutions today to deliver the breakthroughs of
tomorrow, and profoundly impact health for humanity. Learn more at
https://www.jnj.com/ or at
www.janssen.com/johnson-johnson-innovative-medicine. Follow us at
@JanssenUS and @JNJInnovMed. Janssen Research & Development,
LLC and Janssen Biotech, Inc. are both Johnson & Johnson
companies.
Cautions concerning Forward-Looking Statements
This press release contains “forward-looking statements”
regarding the acquisition of NM26 from Numab. The reader is
cautioned not to rely on these forward-looking statements. These
statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or known or unknown risks
or uncertainties materialize, actual results could vary materially
from the expectations and projections of Cilag Holding AG, Janssen
Research & Development, LLC, Janssen Biotech, Inc., and/or
Johnson & Johnson. Risks and uncertainties include, but are not
limited to: the potential that the expected benefits and
opportunities of the acquisition may not be realized or may take
longer to realize than expected; challenges inherent in product
research and development, including uncertainty of clinical success
and obtaining regulatory approvals; uncertainty of commercial
success for new products; manufacturing difficulties and delays;
product efficacy or safety concerns resulting in product recalls or
regulatory action; economic conditions, including currency exchange
and interest rate fluctuations; the risks associated with global
operations; competition, including technological advances, new
products and patents attained by competitors; challenges to
patents; changes to applicable laws and regulations, including tax
laws and global health care reforms; adverse litigation or
government action; change in behavior and pending patterns or
financial distress of purchasers of health care services and
products; and trends toward health care cost containment. A further
list and descriptions of these risks, uncertainties, and other
factors can be found in Johnson & Johnson’s Annual Report on
Form 10-K for the fiscal year ended December 31, 2023, including in
the sections captioned “Cautionary Note Regarding Forward-Looking
Statements” and “Item 1A. Risk Factors,” and in Johnson &
Johnson’s subsequent Quarterly Reports on Form 10-Q, and other
filings by Johnson & Johnson with the SEC. Copies of these
filings are available online at www.sec.gov, at www.jnj.com or on
request from Johnson & Johnson. None of Cilag Holding AG,
Janssen Research & Development, LLC, Janssen Biotech, Inc. nor
Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments, except as required by law.
Non-GAAP Financial Measures
This press release includes Adjusted EPS, which represents a
non-GAAP financial measure. The Company believes that providing
this non-GAAP financial measure enhances the Company’s and
investors’ understanding of our financial performance. Non-GAAP
financial measures should not be considered a substitute for, or
superior to, financial measures determined or calculated in
accordance with GAAP. The Company’s definitions of its non-GAAP
financial measures may not be comparable to similarly titled
measures reported by other companies. The most directly comparable
GAAP measure to Adjusted EPS is earnings per share, or EPS. The
Company is not providing a reconciliation of Adjusted EPS to EPS,
however, because Johnson & Johnson does not provide GAAP
financial measures on a forward-looking basis as the Company is
unable to predict with reasonable certainty the ultimate outcome of
adjusted items, such as legal proceedings, unusual gains and
losses, acquisition-related expenses, and purchase accounting fair
value adjustments without unreasonable effort. These items are
uncertain, depend on various factors, and could be material to
Johnson & Johnson's results computed in accordance with
GAAP.
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version on businesswire.com: https://www.businesswire.com/news/home/20240711820115/en/
Media contact: Michelle Romano Mobile: +1 215 385 0372
mromano3@its.jnj.com
Investor contact: Raychel Kruper
investor-relations@its.jnj.com
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