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Johnson & Johnson, Kaken Pharmaceutical Strike Licensing Agreement for the STAT6 Program That Targets Autoimmune, Allergic Diseases

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Under terms of the deal, Johnson & Johnson will gain an exclusive license to the STAT6 program, with Kaken maintaining commercialization rights in Japan.

a girl shows her combed dry skin on the bend of her elbow, redness, roughness, itching from atopic dermatitis, the girl s face is not visible. Image Credit: Adobe Stock Images/Evgeniya Primavera

Image Credit: Adobe Stock Images/Evgeniya Primavera

Johnson & Johnson (J&J) announced that it has agreed to terms on a global licensing agreement with Kaken Pharmaceutical for the global development, manufacturing, and commercialization of Kaken’s STAT6 program. According to the company, the deal includes KP-723, Kaken’s lead candidate, which targets autoimmune and allergic diseases, such as atopic dermatitis (AD). Within the next year, KP-723 is expected to enter several Phase I trials in AD and may have applications in other Th2-mediated diseases, including asthma.1

“To address the significant unmet need for people living with the highly heterogeneous diseases of atopic dermatitis and asthma, we must have multiple treatment candidates in our pipeline that target key pathways driving disease progression,” said David Lee, global immunology therapeutic area head, Johnson & Johnson Innovative Medicine, in a press release. “STAT6 represents a promising area of research, as it offers a potential for an effective and safe oral option for people struggling to manage atopic dermatitis and other autoimmune diseases.”

Under terms of the deal, Kaken will retain the commercialization rights in Japan, where J&J will have an option to enter into a co-promotion agreement with Kaken, with J&J gaining commercialization rights globally. Additionally, Kaken will be eligible to receive an equity investment from Johnson & Johnson Innovation—JJDC, Inc.—the venture capital organization of Johnson & Johnson.1

According to the Allergy and Asthma Network, approximately 31.6 million people in the United States are currently living with AD. Globally, 15% to 20% of children have AD, including 15.1% in the United States. In adults, this number decreased to anywhere from 1% to 3% globally and 7.3% in the United States.

An estimated 91% of patients with AD experience itching symptoms on a daily basis. Additionally, adults with AD experience a 29.8% higher rate of anxiety symptoms, 31.2% for depression, and 33.2% of sleep disturbances compared to the general population.

In adults, it is also reported that 51.3% have had their lifestyles limited as a result, including limited social interactions and an impact on daily activities. In children with AD, there is a 12.6% higher rate of ADHD, 7.74% higher rate of conduct disorders, 7.25% higher rate of anxiety, and 3.97% higher rate of autism compared to the general population. Further, 15.5% of adolescents with AD report suicidal ideation compared to 9.1% of adolescents without it.

In 2015, the total annual cost of AD was estimated to be around $5.3 billion, including an annual average of $600 in out-of-pocket expenses for individual patients, with overall totals of $636 million for office visits, $154 million for prescription medications, $108 million for outpatient hospital visits, and $105 million for emergency department visits.2

According to J&J, AD is the most common inflammatory skin disease and causes significant itching and inflammation. It can also lead to increased risk of skin infections and skin pain, especially when a patient scratches the irritated skin. It can come and go during a patient’s lifetime, while significant flares of the disease are common.1

“Nearly three-quarters of people with atopic dermatitis are not achieving remission with currently available treatments,” said Candice Long, worldwide vice president, Immunology, Johnson & Johnson. “Our investment in KP-723 may allow us to provide a novel treatment option with the convenience of a pill for patients living with this complex immune-mediated disease.”

References

1. Johnson & Johnson to license novel oral assets, further strengthening commitment to atopic dermatitis. J&J. December 26, 2024. Accessed January 3, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-to-license-novel-oral-assets-further-strengthening-commitment-to-atopic-dermatitis

2. Eczema (Atopic Dermatitis) Statistics. Allergy and Asthma Network. Accessed January 3, 2025. https://allergyasthmanetwork.org/what-is-eczema/eczema-statistics/

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