Psoriasis of scalp

Wynzora® Cream is approved and marketed in Italy, Germany, Spain, the United Kingdom, and the United States. SINGAPORE, March 12, 2024 /PRNewswire/ -- Hyphens Pharma International Limited (" Hyphens Pharma", or the " Company", and together with its subsidiaries, the " Group"), Singapore's leading specialty pharmaceutical and consumer healthcare group, is pleased to announce that its subsidiary, Hyphens Pharma Pte. Ltd., has entered into an exclusive license, supply and commercialisation agreement (the " Agreement") with MC2 Therapeutics (" MC2") for the exclusive rights to register and commercialise Wynzora® Cream and all future product extensions and/or improvements for the topical treatment of plaque psoriasis in the 10 ASEAN countries. Wynzora® Cream (), is a leading topical treatment for plaque psoriasis, including scalp psoriasis in adults. Psoriasis sufferers endure a significant psychological burden due to the visible nature of the skin lesions, its comorbidity, and its chronicity[1]. Wynzora® Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate that has demonstrated high efficacy with quick improvement within 1 week in clinical studies[2]. Its dual mode of action targets the hallmark cytokines IL-23 and IL-17A/F immune axis and TNF-α expression in a single product. It is uniquely enabled by MC2's formulation and drug delivery system PAD Technology™, allowing for an effectful convenient-to-use aqueous formulation. Wynzora® Cream has been approved and marketed in key markets including Italy, Germany, Spain, the United Kingdom, and the United States. "Hyphens Pharma is a leading specialty pharma company focused on the commercialisation of innovative pharmaceutical products in the ASEAN region. It has a clear ambition and strategy to grow its dermatology franchise and is an excellent partner for MC2 to leverage Wynzora® in the region, a large and growing market with over 600 million people," said Mr Jesper J. Lange, Chief Executive Officer of MC2, "This deal substantiates our strategy to make Wynzora® available to as many patients suffering from plaque psoriasis as possible globally, as we continue to develop and expand our pipeline of innovative first-in-class drug candidates within immunology and inflammation", added Mr Lange. Mr Lim See Wah ( 林世华 ) , Chairman and CEO of Hyphens Pharma remarked: "MC2's commitment to develop novel treatment paradigms for skin diseases is synergistic with Hyphens' presence and ambition to be a regional leader in ASEAN. Wynzora® is a proven effective treatment for plaque psoriasis in the United States and Europe. Leveraging our strong regulatory and commercial capabilities, we will work closely with MC2 to accelerate the launch of Wynzora® in the ASEAN region, which will benefit Asian patients suffering from psoriasis." Pursuant to the Agreement, the Group will pay MC2 a total of EUR 2.5 million, which includes an upfront payment and fees upon reaching certain regulatory milestones. In addition, MC2 will be entitled to receive fees for sales milestones and double-digit royalties on net sales. The Agreement will not have a material effect on the net tangible assets or earnings per share of the Group for the financial year ending 31 December 2024. About Hyphens Pharma International Limited () Hyphens Pharma International Limited and its subsidiaries (the "Group") is Singapore's leading specialty pharmaceutical and consumer healthcare group, leveraging on its diverse footprint in ASEAN countries. The Group has a direct presence in Singapore, Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering 14 other markets – Bangladesh, Brunei, Cambodia, Hong Kong S.A.R., Macau S.A.R., Myanmar, South Korea, Sri Lanka and Gulf Cooperation Council countries, including Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates. Singapore is the Group's regional headquarters, where its strategic planning, finance, regulatory affairs, research and development, legal, business development and logistics operations are based. The Group's core business comprises the following segments: Specialty Pharma Principals, Proprietary Brands, and Medical Hypermart & Digital. Besides marketing and selling a range of specialty pharmaceutical products in selected ASEAN countries through exclusive distributorship or licensing and supply agreements with brand principals mainly from Europe and the United States, the Group also develops, markets and sells its own proprietary range of dermatological products and health supplement products. In addition, the Group operates a medical hypermart for healthcare professionals, healthcare institutions and retail pharmacies, to supply pharmaceutical products and medical supplies and an online pharmacy for doctors to prescribe and have medications delivered to their patients' homes. About MC2 Therapeutics () MC2 Therapeutics is a commercial stage biotech company focused on developing novel treatment paradigms within immunology and inflammation. Its pioneering approach in immunology is anchored in a deep understanding of skin biology, clinical expertise and cross-silo thinking. Besides Wynzora® Cream, MC2 has a pipeline that includes two first-in-class drug candidates, both in Phase 2 clinical development. This media release has been reviewed by the Company's sponsor, SAC Capital Private Limited (the "Sponsor"). It has not been examined or approved by the Singapore Exchange Securities Trading Limited (the "SGX-ST") and the SGX-ST assumes no responsibility for the contents of this media release, including the correctness of any of the statements or opinions made or reports contained in this media release. CONTACT: Issued on behalf of Hyphens Pharma International Limited, For media enquires contact: Mr Derek Chng / Mr Gerald Woon, Email / DID / Mobile: [email protected]/ (65) 6704 9285 / (65) 9638 8635, [email protected] / (65) 6704 9268 / (65) 9694 8364; The contact person for the Sponsor is Ms Lee Khai Yinn (Tel: (65) 6232 3210) at 1 Robinson Road, #21-00 AIA Tower, Singapore 048542. SOURCE Hyphens Pharma International Limited

Long-term extension (LTE) FRONTIER 2 study demonstrated sustained efficacy and similar safety results from Week 16 to Week 52, consistent with previously reported FRONTIER 1 16-week Phase 2b study The proportion of patients achieving PASI 75, 90 and 100 response rates at Week 16 were maintained through Week 52, confirming the durability of response 59.5% and 64.3% of patients in the highest dose group (100 mg BID) achieved a PASI 90 response at Weeks 16 and 52 respectively; PASI 90 is a co-primary endpoint for multiple Phase 3 studies in the ICONIC clinical development program No evidence of dose-dependent increase in AEs across the JNJ-2113 treatment groups NEWARK, CA / ACCESSWIRE / March 11, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or "the Company") today announced a late-breaking presentation at the American Academy of Dermatology (AAD) 2024 Annual Meeting with positive results from the Phase 2b FRONTIER 2 long-term extension study evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor, for adult patients with moderate-to-severe plaque psoriasis (PsO). JNJ-2113 is being developed by J&J Innovative Medicine, Inc. (see today's accompanying press release from J&J), under a license and collaboration agreement with Protagonist, and is currently enrolling four pivotal Phase 3 psoriasis studies in the ICONIC clinical development program and one Phase 2b ulcerative colitis study. FRONTIER 2 enrolled patients who completed the 16-week dose ranging FRONTIER 1 Phase 2b study and evaluated patients from Week 17 through Week 52. In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque psoriasis, as measured by Psoriasis Area and Severity Index (PASI) response rates of 75%, 90% and 100%. Recently, results from FRONTIER 1 were published in The New England Journal of Medicine and showed superior efficacy of JNJ-2113 at all doses tested and similar safety compared to placebo at Week 16. "The positive and consistent results from the 52-week FRONTIER 2 study demonstrate the durability of response observed in the 16-week FRONTIER 1 study and reaffirm JNJ-2113's potential as the best-in-class oral agent for psoriasis," said Dinesh V. Patel, PhD, President and CEO of Protagonist. "We continue to believe that JNJ-2113 can potentially have a transformative impact on the treatment of psoriasis and look forward to its assessment across a spectrum of other IL-23-mediated diseases, including the Phase 2b ANTHEM ulcerative colitis study." In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque psoriasis. In the five JNJ-2113 treatment groups, response rates were maintained from Week 16 to Week 52 with the highest PASI 75 response observed in the 100 mg twice daily group (78.6% at 16 weeks and 76.2% at 52 weeks). Similar to the primary endpoint, responses were maintained through Week 52 for all five JNJ-2113 treatment groups for the key secondary endpoints of PASI 90 (59.5% at 16 weeks and 64.3% at 52 weeks), PASI 100 (40.5% at 16 weeks and 40.5% at 52 weeks), Investigator's Global Assessment (IGA) 0/1 (64.3% at 16 weeks and 73.8% at 52 weeks) and IGA 0 (45.2% at 16 weeks and 42.9% at 52 weeks). A summary of PASI responder data from the FRONTIER 2 study at Week 52: # Cohort PASI 75 (%) PASI 90 (%) PASI 100 (%) 1 25 mg daily (n=43) 48.8 27.9 14.0 2 25 mg twice daily (n=41) 58.5 36.6 17.1 3 50 mg daily (n=43) 69.8 41.9 20.9 4 100 mg daily (n=43) 65.1 51.2 25.6 5 100 mg twice daily (n=42) 76.2 64.3 40.5 6 Placebo switched to 100 mg daily (n=43) 65.7 57.1 34.3 Safety in the FRONTIER 2 long-term extension study (Week 17 through Week 52) was found to be consistent with the observations made in the FRONTIER 1 study. Treatment was generally well tolerated, and the proportions of patients with adverse events were comparable between patient groups. There was no evidence of dose-dependent increase in AEs across the treatment groups. The four Phase 3 ICONIC studies in the clinical development program are currently underway to evaluate the safety and efficacy of JNJ-2113 in adults with moderate-to-severe plaque PsO, including the ICONIC-LEAD and ICONIC-TOTAL studies. The ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 will evaluate the safety and efficacy of JNJ-2113 compared with both placebo and deucravacitinib. In addition, J&J is enrolling the Phase 2b ANTHEM-UC study to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in participants with moderately-to-severely active ulcerative colitis. About FRONTIER 2 FRONTIER 2 (NCT05364554) is a Phase 2b multicenter, double-blind, long-term extension, dose-ranging study to evaluate the efficacy and safety of JNJ-77242113 (JNJ-2113) for the treatment of moderate-to-severe plaque psoriasis. The study evaluated four once-daily and two twice-daily dosages of JNJ-2113 taken orally. The originating study (FRONTIER 1) began with its first participant screened on February 3, 2022. A total of 337 participants were screened of which 255 participants were randomized into six treatment groups (Placebo (n=43), 25 mg daily (n=43), 50 mg daily (n=43), 25 mg twice daily (n=41), 100 mg daily (n=43), 100mg twice daily (n=43)). At Week 16, a total of 227 participants from FRONTIER 1 entered FRONTIER 2, the long-term extension study, and received at least one dose of study intervention (Placebo switched to 100 mg daily (n=35), 25 mg daily (n=35), 50 mg daily (n=39), 25 mg twice daily (n=40), 100 mg daily (n=40), 100 mg twice daily (n=38)). The first participant in FRONTIER 2 study was dosed on June 10, 2023. The total duration of the trial was 52 weeks. About JNJ-77242113 (JNJ-2113) JNJ-2113 was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and J&J, which retains exclusive worldwide rights to develop JNJ-2113 in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications. The license and collaboration agreement, established in 2017, enabled the companies to work together to discover and develop next-generation compounds that ultimately led to JNJ-2113. Investigational JNJ-2113 is the first targeted oral peptide designed to block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque psoriasis (PsO) and other IL-23-mediated diseases. JNJ-2113 binds to the IL-23 receptor with single-digit picomolar affinity and has demonstrated potent, selective inhibition of IL-23 signaling in human T cells. IL-23 plays a critical role in pathogenic T-cell activation in moderate-to-severe plaque PsO and underpins the inflammatory response in PsO and other dermatological, rheumatological and gastroenterological IL-23-mediated diseases. About Protagonist Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and JNJ scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Rusfertide will be co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda entered into in January 2024. The agreement will be effective upon the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at . Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential clinical pro JNJ-2113. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreement with JNJ, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release. Investor Relations Contact: Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com Media Contact: Virginia Amann, Founder/CEO ENTENTE Network of Companies virginiaamann@ententeinc.com SOURCE: Protagonist Therapeutics View the original press release on accesswire.com

JNJ-2113 long-term extension FRONTIER 2 study demonstrated sustained efficacy from Week 16 to Week 52 and safety results consistent with previously reported data (FRONTIER 1 Study) in a late-breaking oral presentation at the American Academy of Dermatology 2024 Annual Meeting SAN DIEGO, March 9, 2024 /PRNewswire/ -- Johnson & Johnson today announced the first data from FRONTIER 2, the long-term extension of the Phase 2b FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor (Abstract #S026).1,2 IL-23 plays a critical role in pathogenic T-cell activation in moderate-to-severe plaque psoriasis (PsO) and underpins the inflammatory response in PsO and other dermatological, rheumatological and gastroenterological IL-23-mediated diseases.3,4 In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque PsO.1 In the five JNJ-2113 treatment groups, as measured by the Psoriasis Area and Severity Index (PASI)a, response rates were maintained from Week 16 to Week 52, with the highest PASI 75 response observed in the 100 mg twice daily group (78.6 at 16 weeks and 76.2 percent at 52 weeks).1,b Similar to the primary endpoint, responses were maintained through Week 52 for all five JNJ-2113 treatment groups for the key secondary endpoints of PASI 90 (59.5 at 16 weeks and 64.3 percent at 52 weeks), PASI 100 (40.5 percent at 16 weeks and 40.5 percent at 52 weeks), Investigator's Global Assessment (IGA)c 0/1 (64.3 percent at 16 weeks and 73.8 percent at 52 weeks) and IGA 0 (45.2 percent at 16 weeks and 42.9 percent at 52 weeks).1 Safety in the FRONTIER 2 long-term extension study (Week 16 through Week 52) was found to be consistent with FRONTIER 1.1,2 Across JNJ-2113 treatment groups, 58.6 percent of patients experienced adverse events (AEs), with no evidence of dose-dependent increase in AEs, including gastrointestinal disorders.1 The most frequently reported AEs were nasopharyngitis (18.1 percent), upper respiratory tract infection (9.7 percent) and COVID-19 (5.3 percent).1 Serious AEs were uncommon, occurring in 4 percent of the combined JNJ-2113 patients through Week 52, and all serious AEs were considered unrelated to study treatment.1 "Data from the FRONTIER 2 study showed that the skin clearance as seen by PASI 75 and higher-bar PASI 90 and 100 responses at 16 weeks was maintained at 52 weeks with no new safety signals across all JNJ-2113 treatment groups," said Laura Ferris, M.D., Ph.D., Professor of Dermatology, University of Pittsburgh.d "These findings suggest the potential for JNJ-2113 to continue delivering clinically meaningful results, and addresses the high unmet need for a novel, durable, and convenient oral therapeutic option for people living with moderate-to-severe plaque psoriasis." In FRONTIER 2, patients who originally received JNJ-2113 in FRONTIER 1 during the first 16 weeks continued with the same dosing regimen they received in the earlier part of the trial.1 Patients who were originally in the placebo group received JNJ-2113 100 mg once daily in FRONTIER 2.1 Data from the Phase 2b FRONTIER 1 study evaluating JNJ-2113 in adults with moderate-to-severe PsO were recently published in The New England Journal of Medicine.5 The pivotal Phase 3 ICONIC clinical development program is currently underway to evaluate the safety and efficacy of JNJ-2113 in adults with moderate-to-severe plaque PsO, including the ICONIC-LEADe and ICONIC-TOTALf studies – pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc.6 Other Phase 3 studies in the development program have been initiated, including ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which will evaluate the safety and efficacy of JNJ-2113 compared with both placebo and deucravacitinib.7 The findings from the FRONTIER 1 and FRONTIER 2 clinical trials suggest the potential of JNJ-2113 across the spectrum of additional IL-23-mediated diseases.1,8 Accordingly, J&J has initiated the Phase 2b ANTHEM-UC study to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in participants with moderately to severely active ulcerative colitis.8 "Our strong commitment to innovation in Immunodermatology advances our overall mission to bring new treatment options to market to achieve remission in patients with immune-mediated conditions," said Lloyd Miller, M.D., Ph.D., Vice President, Immunodermatology Disease Area Leader, Johnson & Johnson. "With promising longer-term results showcasing one year of JNJ-2113 data from the FRONTIER 2 study, our focused innovation in the IL-23 pathway provides an exciting opportunity to unlock a new and potentially differentiated treatment option for patients with psoriasis." Editor's Notes: About FRONTIER 2 FRONTIER 2 (NCT05364554) is a Phase 2b multicenter, double-blind, long-term extension, dose-ranging study to evaluate the efficacy and safety of JNJ-77242113 (JNJ-2113) for the treatment of moderate-to-severe plaque psoriasis.12 The study evaluated four once-daily and two twice-daily dosages of JNJ-2113 taken orally.12 The originating study (FRONTIER 1) began with its first participant screened on February 3, 2022.13 A total of 337 participants were screened of which 255 participants were randomized into six treatment groups (Placebo (n=43), 25 mg daily (n=43), 50 mg daily (n=43), 25 mg twice daily (n=41), 100 mg daily (n=43), 100mg twice daily (n=43)).12 At Week 16, a total of 227 participants from FRONTIER 1 entered FRONTIER 2 long-term extension study and received at least one dose of study intervention (Placebo → 100 mg daily (n=35), 25 mg daily (n=35), 50 mg daily (n=39), 25 mg twice daily (n=40), 100 mg daily (n=40), 100 mg twice daily (n=38)).12 The first participant in FRONTIER 2 study was dosed on June 10, 2023.12 A total of 227 participants were randomized into six treatment groups. The total duration of the trial was 52 weeks.12 About Plaque Psoriasis Plaque psoriasis (PsO) is an immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.14 It is estimated that eight million Americans and more than 125 million people worldwide live with the disease.15 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe.15 Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life.16 About JNJ-77242113 (JNJ-2113) JNJ-2113 was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist Therapeutics and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop JNJ-2113 in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.17,18,19 Investigational JNJ-2113 is the first targeted oral peptide designed to block the IL-23 receptor,2 which underpins the inflammatory response in moderate-to-severe plaque PsO and other IL-23-mediated diseases.3,4 JNJ-2113 binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells.20 The license and collaboration agreement established between Protagonist and Janssen Biotech, Inc., in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to JNJ-2113.21 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  or at . Follow us at @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" as defined in the Private Securities Litigation Reform Act of 1995 regarding JNJ-2113. 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 Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; 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 with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of 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. __________________________________ 1 Ferris, L et al. A Phase 2b, Long-term Extension, Dose-ranging Study of Oral JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis: FRONTIER 2. Oral presentation (Abstract #S026) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2024. 2 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8. 3 Razawy W, et al. The role of IL–23 receptor signaling in inflammation–mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229. 4 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124. 5 Bissonnette R, et al. An oral interleukin-23–receptor antagonist peptide for plaque psoriasis. N Engl J Med. 2024;390:510-21. DOI: 10.1056/NEJMoa2308713. 6 Protagonist Therapeutics. Press release. Protagonist announces advancement of JNJ-2113 across multiple indications. Available at: . Accessed March 2024. 7 Protagonist Therapeutics. Press release. Protagonist announces two new phase 3 ICONIC studies in psoriasis evaluating JNJ-2113 in head-to-head comparisons with deucravacitinib. Available at: . Accessed March 2024. 8 Clinicaltrials.gov. A study of JNJ-2113 in participants with moderately-to-severely active ulcerative colitis (ANTHEM-UC). Identifier NCT06049017. . Accessed March 2024. 9 Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: . Accessed March 2024. 10 Clinicaltrials.gov. A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. . Accessed March 2024. 11 Clinicaltrials.gov. A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. . Accessed March 2024. 12 Clinicaltrials.gov. A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis (FRONTIER 2). Identifier NCT05364554. . Accessed March 2024. 13 Clinicaltrials.gov. A study of JNJ-2113 in participants with moderate-to-severe plaque psoriasis (FRONTIER 1). Identifier NCT05223868. . Accessed March 2024. 14 National Psoriasis Foundation. About psoriasis. Available at: . Accessed March 2024. 15 National Psoriasis Foundation. Psoriasis statistics. Available at: . Accessed Marc 2024. 16 National Psoriasis Foundation. Life with psoriasis. Available at: . Accessed March 2024. 17 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: . Accessed March 2024. 18 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: . Accessed January 2024. 19 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: . Accessed January 2024. 20 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14. 21 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: . Accessed March 2024. Media contact: Craig Stoltz Mobile: (215) 779-9396 [email protected] Investor contact: Raychel Kruper [email protected] SOURCE Johnson & Johnson