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Johnson & Johnson to Obtain Rights to a Clinical-Stage Bispecific Antibody to Address Distinct Patient Needs in Atopic Dermatitis

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Johnson & Johnson (NYSE: JNJ) announced a definitive agreement to acquire Numab Therapeutics' subsidiary for global rights to NM26, a Phase 2-ready bispecific antibody.

This $1.25 billion all-cash deal focuses on NM26, which targets IL-4Rα and IL-31 pathways in atopic dermatitis (AD). NM26 aims to address unmet needs in AD by offering a unique treatment for inflammation and itch.

The transaction is expected to close in the second half of 2024, pending regulatory clearance. Johnson & Johnson plans to develop more bispecific antibodies for AD and other immune-mediated diseases.

Positive
  • Acquisition of NM26 for $1.25 billion strengthens Johnson & Johnson's immunology pipeline.
  • NM26 targets two clinically proven pathways, potentially transforming AD treatment.
  • Transaction expected to close in H2 2024, indicating forward momentum.
  • Development of NM26 aligns with Johnson & Johnson's strategy for differentiated bispecifics.
Negative
  • High acquisition cost of $1.25 billion may impact short-term financials.
  • Uncertainty around Phase 2 trial outcomes for NM26.
  • Potential regulatory delays as closing depends on Hart-Scott-Rodino Antitrust clearance.

Insights

Johnson & Johnson's (JNJ) acquisition of Numab Therapeutics' subsidiary for $1.25 billion is strategically significant. This purchase grants JNJ the global rights to NM26, a first-in-class bispecific antibody targeting atopic dermatitis (AD).

From a financial perspective, this acquisition represents JNJ's commitment to expanding its immunology portfolio. The potential for NM26 to address unmet needs in AD treatment could translate into substantial revenue streams if clinical trials succeed. However, the success of this investment hinges on NM26's efficacy and safety data from Phase 2 trials, as well as the subsequent regulatory approvals.

Retail investors should note that JNJ's strong balance sheet allows it to invest in innovative therapeutics without jeopardizing its financial stability. However, the inherent risks in clinical trials and regulatory processes should be acknowledged. Historically, the pharmaceutical sector has faced setbacks in drug development, which can impact stock performance.

NM26's dual-targeting mechanism (IL-4Rα and IL-31) sets it apart from current AD therapies. This bispecific antibody approach could provide more effective relief for AD patients by addressing both inflammation and itch, two critical components of the disease. The fact that 70% of patients do not achieve remission with existing treatments highlights a substantial market opportunity for NM26.

Understanding the science behind IL-4Rα (a trigger of Th2-mediated inflammation) and IL-31 (responsible for itch) is crucial. Targeting these pathways may not only alleviate symptoms but also reduce the risk of infections and improve the overall quality of life for patients. If successful, NM26 could set a new standard of care, making JNJ a leader in the dermatology space.

The global AD market is poised for growth, driven by increasing diagnosis rates and a rising prevalence of chronic skin diseases. JNJ's investment in NM26 reinforces its strategic focus on addressing significant unmet medical needs. Given the competitive landscape, where companies like Sanofi and Regeneron have made strides with Dupixent, NM26's unique mechanism can offer a competitive edge.

Investors should consider the market potential not just in AD but also in other inflammatory skin diseases NM26 could target. JNJ's established distribution networks and marketing capabilities position it well to capitalize on NM26's success if clinical trials prove favorable. This strategic move aligns with industry trends of developing targeted, patient-specific therapies, which could redefine treatment paradigms.

The Company1 enters agreement with Numab Therapeutics to acquire its wholly owned subsidiary2 for the global rights to NM26, a Phase 2-ready investigational, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis (AD)

NM26 has the potential to offer distinctive benefits versus existing treatments and address key unmet needs for AD patients

Johnson & Johnson is committed to developing differentiated bispecific antibodies for treating AD and other immune-mediated diseases

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) announced today it has entered into a definitive agreement with Numab Therapeutics, a clinical-stage biotechnology company advancing a pipeline of immunology and oncology therapeutics, to acquire from Numab's shareholders its wholly-owned subsidiary for the global rights to a novel, investigational first-in-class bispecific antibody, NM26, in an all-cash transaction of approximately $1.25 billion.

NM26, which is ready to enter Phase 2 studies, targets two clinically proven pathways, IL-4R alpha subunit (IL-4Rα) and IL-31, in atopic dermatitis (AD). Atopic dermatitis, the most common inflammatory skin disease3, is highly heterogeneous with different disease-driving mechanisms in distinct patient subpopulations. NM26 targets IL-4Rα, which triggers Th2-mediated skin inflammation4, and IL-31, which impacts skin itch and subsequent scratching that worsen the disease5. In addition to potentially transforming the standard of care for AD, NM26 could also be efficacious in other inflammatory skin diseases involving Th2 inflammation and itch.

“To deliver durable, symptom-free remission for the millions of people living with AD, our medicines need to be tailored to target multiple disease-driving pathways in different patient subpopulations,” said David Lee, Global Immunology Therapeutic Area Head, Johnson & Johnson Innovative Medicine. “That’s why we are committed to developing differentiated bispecifics that combine the targeting of two distinct disease-driving pathways. NM26 has the potential to deliver a treatment specifically for patients who have inflamed skin associated with intense itching.”

People living with AD experience inflamed skin that can be associated with itch and subsequent scratching, which causes skin pain, skin abrasions that increase risk of infection, difficulty sleeping, anxiety, stress, depression and even an increased risk of suicide. Current therapies fall short of delivering durable, symptom-free remission, with approximately 70% of patients not achieving remission in what is the most common inflammatory skin disease.6

“Our goal is to deliver transformational efficacy for all patients living with immune mediated diseases like AD,” said Candice Long, Worldwide Vice President, Immunology, Johnson & Johnson. “Our investment in differentiated bispecifics is the next chapter in our impactful Immunology legacy. It reinforces our commitment to address unmet medical needs by leveraging patient insights and our deep disease expertise.”

The closing of the transaction is expected to occur in the second half of 2024, following clearance under the Hart-Scott-Rodino Antitrust Improvements Act and satisfaction of other customary closing conditions. Accounting treatment will be communicated on or before the close of the transaction.

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. Cilag Holding AG, Janssen Research & Development, LLC and Janssen Biotech, Inc. are all 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.

1 Legal entity, Cilag Holding AG
2 J&J will acquire Numab’s NM26 program on a global basis by way of the purchase of 100% of the issued and outstanding shares of a newco, Yellow Jersey Therapeutics, which will include the NM26 program, and which will be formed through a demerger with Numab. J&J will enter a separate agreement with Kaken Pharmaceutical to secure rights in the Asia Pacific region.
3 https://pubmed.ncbi.nlm.nih.gov/27690741/
4 https://pubmed.ncbi.nlm.nih.gov/27690741/
5 https://onlinelibrary.wiley.com/doi/full/10.1111/bjd.20873
6 https://pubmed.ncbi.nlm.nih.gov/27690741/

Media contact:

Michelle Romano

Mobile: 215 385 0372

mromano3@its.jnj.com

Investor contact:

Raychel Kruper

Investor-relations@its.jnj.com

Source: Johnson & Johnson

FAQ

What is Johnson & Johnson's recent acquisition related to?

Johnson & Johnson is acquiring Numab Therapeutics' subsidiary for global rights to NM26, a Phase 2-ready bispecific antibody.

How much is Johnson & Johnson paying for the NM26 rights?

Johnson & Johnson is paying approximately $1.25 billion in an all-cash transaction.

What are the targeted pathways of NM26?

NM26 targets two clinically proven pathways: IL-4Rα and IL-31.

When is the transaction expected to close?

The transaction is expected to close in the second half of 2024, following regulatory clearance.

What potential benefits does NM26 offer for atopic dermatitis (AD)?

NM26 aims to address unmet needs in AD by targeting inflammation and itch, potentially offering a unique treatment.

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