La Jolla Labs, Inc.

SPROUT 52-Week Data Demonstrate Durable Response and Consistent Safety Profile of Oral Otezla in Children with Moderate to Severe Plaque Psoriasis Late-Breaking Phase 3 Study of Otezla in Palmoplantar Pustulosis Achieves Primary and Secondary Endpoints at 16 Weeks THOUSAND OAKS, Calif., March 9, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new, 52-week results from the Phase 3 SPROUT study examining the use of Otezla® (apremilast) in children and adolescents aged 6 to 17 years with moderate to severe plaque psoriasis. These data, along with findings from a Phase 3 late-breaking study on Otezla in palmoplantar pustulosis, will be presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San Diego. "These data reflect Amgen's commitment to exploring new ways to treat inflammatory skin disease," said Ponda Motsepe-Ditshego, vice president, Global Medical, at Amgen. "A decade after the launch of Otezla, we continue to study how this oral therapy can help improve care and reduce disease burden in underserved patient populations." SPROUT Phase 3 Study Results from SPROUT, a multicenter, randomized, placebo-controlled, double-blind study, demonstrated the efficacy and safety of Otezla in pediatric patients aged 6 to 17 years with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy. Continued Otezla use resulted in sustained improvements in psoriasis severity and skin involvement in patients for up to one year. The safety profile was consistent with previous Otezla studies. These findings add to the published 16-week results.1 "For the first time, we have a full year of data on a potential oral treatment for children and adolescents with moderate to severe plaque psoriasis, who currently lack any approved oral treatment options," said Loretta Fiorillo, M.D., FRCPC, clinical professor of pediatrics, University of Alberta. "At 52 weeks, more than half of patients achieved clear or almost clear skin. Otezla showed increased efficacy beyond that seen at the week 16 primary endpoint, with a durable maintenance of response – an important finding for families living with this chronic inflammatory disease." All patients in the study received Otezla for a 36-week extended active treatment period following the 16-week randomized placebo-controlled treatment period, providing up to 52 weeks of data. There were 186 patients who completed the 36-week extension: 125 who continued to receive Otezla, and 61 patients switched from placebo to Otezla. Study findings include:2 56.3% of patients who received Otezla through week 52 achieved static Physician Global Assessment (sPGA) response (score of ≥3), an investigator assessment of overall disease severity of plaque psoriasis, the study's primary endpoint. 52.5% of patients who switched from placebo to Otezla achieved sPGA response at week 52. 71.4% of patients who received Otezla through week 52 achieved Psoriasis Area and Severity Index (PASI)-75, an investigator assessment of disease severity and skin involvement, a secondary endpoint. 75.4% of patients who switched from placebo to Otezla achieved PASI-75 at week 52. Treatment-emergent adverse events (AEs) were consistent with the known safety profile of Otezla in adults. The most common AEs (>10%) throughout the study were nausea, diarrhea, abdominal pain, vomiting and headache. Findings will be presented as an e-poster with an oral presentation on Saturday, March 9 at 4:50 p.m. PST. Phase 3 Late-Breaking Palmoplantar Pustulosis Findings Amgen also will present late-breaking findings from a Phase 3 study evaluating the efficacy and safety of Otezla in patients with moderate to severe palmoplantar pustulosis in Japan following inadequate response to topical therapy. Palmoplantar pustulosis is a chronic inflammatory condition characterized by pustules on the palms and soles. The condition can be difficult to treat, with limited available treatment options.3,4 "Palmoplantar pustulosis can severely impact daily functioning due to its painful effects on the hands and feet, necessitating new therapeutic options for this impactful inflammatory skin condition," said Melinda Gooderham, M.D., FRCPC, dermatologist and clinical investigator at SKiN Centre for Dermatology and assistant professor, Queen's University, Ontario, Canada. "The study presented at AAD highlighted significant improvement in disease severity, symptoms such as itch, pain, discomfort, and patient-reported quality of life among those treated with Otezla compared to placebo." The randomized, placebo-controlled, double-blind study included 176 patients who received Otezla (n=88) or placebo (n=88) for 16 weeks. All primary and secondary endpoints were met. Study findings include:5 67.8% of patients who received Otezla achieved the primary endpoint of PPPASI 50 (>50% improvement in the Palmoplantar Pustulosis Area and Severity Index); this was a significantly greater response as compared to placebo (35.3%; P<0.0001). Statistically significant improvements in all secondary endpoints were observed with Otezla relative to placebo, including changes from baseline to week 16 in PPPASI, PPSI (Palmoplantar Pustulosis Severity Index), Patient Visual Analogue Scale of palmoplantar pruritus and pain/discomfort and DLQI (Dermatology Life Quality Index). Treatment-emergent AEs were consistent with the known safety profile of Otezla. The most common AEs (>10%) throughout the study were diarrhea, soft feces, headache and nausea. Findings will be presented as a late-breaking oral presentation on Saturday, March 9 at 9:20 a.m. PST. Additional Amgen data to be presented at AAD include: Otezla Abstracts Long-term Impact of Apremilast on Cardiometabolic Parameters and the Relationship of Cardiometabolic Changes with Psoriasis Efficacy Abstract #50668, E-Poster and Oral Presentation of Poster on Saturday, March 9 at 3:55 p.m. PST Beyond Race-Ethnicity: Fitzpatrick Skin Type Analysis Highlights Unmet Needs and Differing Treatment Patterns in Psoriasis Among the Conventional Systemics Cohort of British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR) Abstract #51067, E-Poster and Oral Presentation of Poster on Saturday, March 9 at 4:15 p.m. PST Apremilast Improves Clinical Outcomes and Pain in Patients with Oligoarticular Psoriatic Arthritis Abstract #51246, E-Poster Efficacy of Apremilast in Adults with Mild-to-Moderate Plaque Psoriasis with Scalp Involvement: Pooled Data from PROMINENT, ADVANCE, and EMBRACE Trials Abstract #51480, E-Poster Proportion of the US Psoriasis Population Impacted by Common Warnings for Moderate-to-Severe Plaque Psoriasis Treatment Abstract #52846, E-Poster Rocatinlimab (AMG 451/KHK4083) Abstract Rocatinlimab Significantly Improves Clinical Responses in Patients with Moderate-to-Severe Atopic Dermatitis by Week 2 in a Randomized Double-Blind Placebo-Controlled Phase 2b Study Abstract #50233, E-Poster About Psoriasis Psoriasis is a chronic disease where skin cells build up quickly, typically causing red or discolored, scaly, and itchy patches on the skin.6 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 8 million people in the United States.7,8 About 80% of those patients have plaque psoriasis.9 About Otezla® (apremilast) Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 920,000 patients worldwide.10 Otezla® (apremilast) U.S. INDICATIONS INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla is indicated for the treatment of adult patients with active psoriatic arthritis. Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease. Otezla® (apremilast) U.S. IMPORTANT SAFETY INFORMATION Contraindications Otezla® is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation Warnings and Precautions Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla Behçet's Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo Behçet's Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended Adverse Reactions Plaque Psoriasis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in patients with mild to moderate plaque psoriasis was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis Psoriatic Arthritis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache Behçet's Disease: The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection Use in Specific Populations Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Please click here for Otezla® Full Prescribing Information. About Atopic Dermatitis Atopic dermatitis is a chronic inflammatory disease that causes excessively dry, itchy skin that can be painful. Repeated scratching can cause the skin to thicken, harden or become vulnerable to infection. Atopic dermatitis is the most common form of eczema – affecting 1-3% of adults worldwide – and the prevalence is increasing. The disease typically manifests in childhood followed by other allergy symptoms. About rocatinlimab Rocatinlimab (AMG 451/KHK4083), an investigational product, is a potential first-in-class anti-OX40 monoclonal antibody that is being studied for its ability to inhibit and reduce the number of OX40+ pathogenic T cells responsible for driving systemic and local AD inflammatory responses. It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology. The initial antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology. Amgen and Kyowa Kirin Collaboration On June 1, 2021, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083/AMG 451 for all markets globally, except Japan, where Kyowa Kirin will retain all rights. If approved, the companies will co-promote the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia. About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME. For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn, Instagram, TikTok, YouTube and Threads. Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. 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In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. 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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Kate Meyer, 872-867-0754 (media) Jessica Akopyan, 805-440-5721 (media) Justin Claeys, 805-313-9775 (investors) References 1Fiorillo L, Becker E, de Lucas R, Belloni-Fortina A, Armesto S, Maes P, Oberoi R, Paris M, Zhang W, Zhang Z, & Arkin L. Efficacy and safety results of apremilast in pediatric patients with moderate to severe plaque psoriasis: 16-week results from SPROUT, a phase 3, randomized, controlled study. SKIN, 2023;7(2):s109; . 2Fiorillo L, et al. Efficacy and Safety of Apremilast in Pediatric Patients With Moderate to Severe Plaque Psoriasis: 52-Week Results From the SPROUT Randomized Controlled Trial. AAD Annual Meeting, March 2024. 3Brunasso AMG and Massone C. Recent advances in palmoplantar pustulosis. Faculty Reviews 2021 10:(62) . 4Chung J, Callis Duffin K, Takeshita J, Shin DB, Krueger GG, Robertson AD, et al. Palmoplantar psoriasis is associated with greater impairment of health-related quality of life compared with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2014 Oct; 71(4):623-32. doi: 10.1016/j.jaad.2014.04.063. 5 Terui T, et all. Efficacy and Safety of Apremilast for the Treatment of Japanese Patients With Palmoplantar Pustulosis (PPP): 16-Week Results From a Phase 3, Randomized, Placebo-Controlled Study. AAD Annual Meeting, March 2024. 6National Psoriasis Foundation. About Psoriasis. Available at: . Accessed January 30, 2024. 7National Psoriasis Foundation. Statistics. Available at: . Accessed January 30, 2024. 8Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol. 2004;14(1):41–45. 9National Psoriasis Foundation. Plaque Psoriasis. Available at: . Accessed January 30, 2024. 10Amgen Data on File. November 2023. SOURCE Amgen

PRINCETON, N.J. and TOKYO, March 8, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that post-hoc analysis data from the Phase 2b study of rocatinlimab (AMG 451/KHK4083), an investigational product in patients with moderate-to-severe atopic dermatitis (msAD), will be presented at the American Academy of Dermatology (AAD) 2024 Annual Meeting to be held in San Diego from March 8-12, 2024. Atopic Dermatitis (AD), a chronic, heterogeneous, inflammatory disease characterized by skin redness, pruritus, and pain, is driven by skin barrier disruption and T cell–dependent inflammatory pathways; the relative contribution of different inflammatory pathways in driving disease can vary across populations and within individuals over time. Patients with msAD continue to need additional treatment options due to ongoing symptoms like pruritis. Thus, there remains a need for therapeutic options that can deliver benefits across a heterogeneous AD patient population. e-poster: Rocatinlimab Significantly Improves Clinical Responses in Patients with Moderate-to-Severe Atopic Dermatitis by Week 2 in a Randomized Double-Blind Placebo-Controlled Phase 2b Study, will be available starting Friday, March 8. Author: Emma Guttman- Yassky, MD, PhD et al A multicenter, randomized, double-blind, placebo-controlled Phase 2b trial (NCT03703102) evaluated rocatinlimab for msAD. Primary endpoint achievement (Week 16 Eczema Area and Severity Index [EASI]) has been presented. Randomized patients (1:1:1:1:1) received subcutaneous rocatinlimab 150mg/600mg every 4 weeks (Q4W) or 300mg/600mg every 2 weeks (Q2W) for 36 weeks, or placebo (Weeks 0–18) followed by rocatinlimab (600mg Q2W Weeks 18–36). All cohorts had 20-week off-treatment follow-up. The current post-hoc analysis (267 patients; rocatinlimab: n=210, placebo: n=57) of the phase 2b study evaluated EASI and pNRS between baseline and week 16 to investigate early clinical response. Difference in least squares mean of percent change from baseline between rocatinlimab cohorts and placebo were assessed. The post hoc analysis showed statistically significant improvement in pNRS scores for patients in the treatment arms compared to placebo. Pruritis improved with rocatinlimab by Week 2 in all cohorts (−18.40% to −21.96%; p≤0.018) except 600mg Q4W (−9.66%; p=0.208), and in all cohorts by Week 4 (−15.70% to −27.19%; p≤0.045); EASI improvements vs. placebo were significant in all rocatinlimab cohorts by Week 6 (−20.50% to −32.13%; p≤0.001), and the 300mg & 600mg Q2W cohorts by Week 2 (−13.27% and −13.66%; p≤0.028). Further improvements vs. placebo continued to Week 16; improvements vs. baseline continued in all active cohorts to Week 36 and were maintained for 20 weeks off-treatment. Adverse events reported were generally similar between rocatinlimab groups. Common adverse events during the double-blind period included fever, chills, headache, aphthous ulcers and nausea. An Amgen & Kyowa Kirin co-sponsored symposium: From Heterogeneity Comes New Insights: Exploring the role of T Cells and OX40 in Atopic Dermatitis Presenters: Chih-ho Hong, MD, Clinical Assistant Professor at the University of British Columbia Raj Chovatiya, MD, PhD, Assistant Professor of Dermatology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois Date: Saturday, March 9th, 11:15 am Location: Exhibit Hall, Theater 2 About rocatinlimab Rocatinlimab (AMG 451/KHK4083), an investigational product, is a potential first-in-class anti-OX40 monoclonal antibody that is being studied for its ability to inhibit and reduce the number of OX40+ pathogenic T cells responsible for driving systemic and local AD inflammatory responses. It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology. The initial antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology. Amgen and Kyowa Kirin Collaboration On June 1, 2021, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083/AMG 451 for all markets globally, except Japan, where Kyowa Kirin will retain all rights. If approved, the companies will co-promote the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. You can learn more about the business of Kyowa Kirin at: . SOURCE Kyowa Kirin

PRINCETON, N.J. and TOKYO, Feb. 14, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that disease education and data from the Phase 2b study of rocatinlimab (AMG451/KHK4083), an investigational product being studied in patients with moderate-to-severe atopic dermatitis, will be presented at the upcoming American Academy of Dermatology (AAD) 2024 Annual Meeting in San Diego from March 8-12, 2024. Atopic Dermatitis (AD), a chronic, heterogeneous, inflammatory disease characterized by skin redness, pruritus, and pain, is driven by skin barrier disruption and T cell–dependent inflammatory pathways; the relative contribution of different inflammatory pathways in driving disease can vary across populations and within individuals over time. Globally, the prevalence of AD is up to 10% among adults and up to 20% among children, making it the 15th most common non-fatal disease and the skin disorder with the highest disease burden, in terms of disability-adjusted life-years. Despite available therapies, many patients with moderate-to-severe AD fail to achieve or sustain treatment goals and/or may not be suitable for or tolerate these therapies. Thus, there remains a need for therapeutic options that can deliver durable benefits across a heterogeneous AD patient population. AD is associated with a significant clinical burden due to unpredictable flares (acute worsening of symptoms) and chronic symptoms, including redness, dryness, and lichenification (skin thickening); clinical burden may be more prominent for those with moderate-to-severe disease. Drs Chih-ho Hong and Raj Chovatiya will highlight data on the heterogeneity of atopic dermatitis and the role of T cells and OX40 signaling in disease pathogenesis. Date: Saturday, March 9 Time: 11:30 am – 12:15 pm PST Location: Exhibit Hall, Theater 2 e-Poster Title: Rocatinlimab Significantly Improves Clinical Responses in Patients with Moderate-To-Severe Atopic Dermatitis by Week 2 in a Randomized Double-Blind Placebo-Controlled Phase 2b Study Author: Emma Guttman- Yassky, MD, PhD Date: Friday, March 8 About rocatinlimab Rocatinlimab (AMG 451/KHK4083), an investigational product, is a potential first-in-class anti-OX40 monoclonal antibody that is being studied for its ability to inhibit and reduce the number of OX40+ pathogenic T cells responsible for driving systemic and local AD inflammatory responses. It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology. The initial antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology. Amgen and Kyowa Kirin Collaboration On June 1, 2021, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083/AMG 451 for all markets globally, except Japan, where Kyowa Kirin will retain all rights. If approved, the companies will co-promote the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia. About Kyowa Kirin Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by severe and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions – Japan, Asia Pacific, North America, and EMEA/International. You can learn more about the business of Kyowa Kirin at: . SOURCE Kyowa Kirin