Secukinumab

Approval is based on the two largest Phase III trials conducted in HS – SUNSHINE and SUNRISE – demonstrating the safety and efficacy of Cosentyx® in HS1 HS is a chronic, immunological, inflammatory skin condition estimated to affect 1 in 100 people worldwide causing painful, boil-like lumps that can lead to open wounds and irreversible scarring2,3,4 The new treatment for HS reinforces Novartis' commitment to delivering new, innovative therapies that improve health outcomes for patients in Canada MONTRÉAL, May 22, 2024 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that Health Canada has granted Cosentyx® (secukinumab) with a Notice of Compliance (NOC) for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS) (acne inversa) who have responded inadequately to conventional systemic hidradenitis suppurativa therapy – representing a safe and efficacious new treatment option for Canadians living with the condition.1 While the exact cause and prevalence of HS is unknown,2 it is estimated to affect 1-4 per cent of the Canadian population4 which equates to between 300,000 and 1 million people.5 HS is considered a chronic and progressive disease, meaning it can worsen over time and have a significant impact on a patient's everyday life.4 "People living with HS often suffer physically and mentally from the effects of the condition," said Latoya Palmer, Founder of Hidradenitis and Me Support Group. "Ensuring there are a wide range of treatment options is vital for each individual to find the right path for them." The safety and efficacy of Cosentyx® was assessed in the two largest Phase III trials ever conducted in HS – SUNSHINE (M2301) and SUNRISE (M2302). The global, multicentre, randomized, double-blind, placebo-controlled clinical trials studied 1,084 adult patients with moderate to severe HS.1 "Patients who have been diagnosed with advanced HS often have limited treatment options available to them," said Dr. Susan Poelman, Dermatologist and President of the HS Foundation in Canada. "The approval of a new treatment option for HS is a welcome new addition for people living with the condition and will bring hope to patients that have achieved suboptimal control with current available therapies." In addition to HS, Cosentyx® has been previously approved for use in Canada for a variety of conditions including plaque psoriasis, psoriatic arthritis, axial spondyloarthritis and juvenile idiopathic arthritis.1 Given its well-known and proven safety profile, Cosentyx® will provide physicians and their patients with more treatment options to decide on the most appropriate course of action to treat their HS. "This approval will offer a new treatment option for patients currently living with HS," added Dr. Mark Kirchhof, Division Head of Dermatology in the Faculty of Medicine at the University of Ottawa and The Ottawa Hospital. "Cosentyx® will provide dermatologists with a familiar treatment for this complex condition." "More than 1 million patients have been treated with Cosentyx® worldwide since its launch in 2015, and we are proud that is now available in Canada as a much-needed treatment to those suffering with HS," said Mark Vineis, Country President Novartis Pharmaceuticals Canada Inc. "This approval is another example of Novartis' commitment to bringing innovative medicines to improve patient outcomes in Canada." About Novartis Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 600 people to serve the evolving needs of patients and the healthcare system, and invests over $30 million in R&D yearly in the country. For more information visit . About the SUNSHINE and SUNRISE trials6,7,8 The SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) trials comprise the largest Phase III program in hidradenitis suppurativa (HS), with a combined enrollment of more than 1,000 patients in 40 countries. SUNSHINE and SUNRISE evaluated the short- (16 weeks) and long-term (up to 52 weeks) efficacy, safety and tolerability of two dose regimens of Cosentyx® (secukinumab) in adults with moderate to severe HS. About Cosentyx® (secukinumab) Cosentyx® is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).9,10 Cosentyx® is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including 5 years of clinical data in adults supporting long-term safety and efficacy across moderate to severe plaque psoriasis, PsA and AS.11,12,13,14,15,16,17 These data strengthen the position of Cosentyx® as a treatment across AS, nr-axSpA, PsA, moderate to severe plaque psoriasis (adult and pediatric) and two subtypes of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis and juvenile psoriatic arthritis.9 More than 1 million patients have been treated with Cosentyx® worldwide since its launch in 2015. 426329E References SOURCE Novartis Pharmaceuticals Canada Inc.

This is the first compound in Zai’s portfolio of internally developed drugs to advance into Phase 2, demonstrating Zai’s global capabilities Based on a proof-of-concept study, ZL-1102 is the first topical biologic to show penetration of psoriatic skin resulting in a clinical response SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the first patient has been dosed in a global Phase 2 clinical trial (NCT06380907) evaluating the efficacy and safety of the company’s internally developed anti-IL-17 investigational therapy, ZL-1102, for the treatment of chronic plaque psoriasis (CPP). ZL-1102 is a novel human VH antibody fragment (Humabody®) targeting the IL-17 cytokine. Emphasizing its unique approach, ZL-1102 is being developed as a topical treatment for mild-to-moderate CPP, differentiating it from other anti-IL-17 products that target moderate-to-severe forms of the disease through systemic administration. “This study marks an important milestone in Zai’s evolution and is a testament to our outstanding internal R&D team’s commitment to develop novel therapies to help patients across the globe,” said Josh Smiley, President and Chief Operating Officer, Zai Lab. “ZL-1102 is the first IL-17 targeted topical treatment in development for patients with less severe forms of CPP. Formulated to be applied directly to psoriatic skin lesions, we hope it can bypass unnecessary tissue exposure and avoid systemic toxicity commonly associated with intravenous or subcutaneous therapies,” said Harald Reinhart, M.D., President and Head of Global Development, Neuroscience, Autoimmune & Infectious Diseases, Zai Lab. “ZL-1102 exemplifies the innovative, patient-focused R&D programs in our internal discovery and development pipeline. We aim to bring this novel treatment option to patients in need as quickly as possible.” Psoriasis affects about 125 million people worldwide; 80% to 90% of these individuals have plaque psoriasis and 70% to 80% of these cases are mild-to-moderate. Most systemic agents, i.e., oral and injectable medications, are prescribed for moderate-to-severe psoriasis. Zai Lab previously reported data from the proof-of-concept study in patients with mild-to-moderate CPP in which topical treatment with ZL-1102 showed a 45% relative improvement compared to placebo in the local Psoriasis Area Severity Index (PASI) score of the target lesion at four weeks, and consistently higher responder rates over time compared to placebo during and after the end of treatment.1 The Phase 2 global clinical trial of ZL-1102 is a randomized, double-blind, vehicle-controlled, dose-ranging study in patients with mild-to-moderate CPP. In this 5-arm trial, approximately 250 patients will receive topical therapy for 16 weeks. The primary endpoint is the proportion of patients achieving modified PASI75, which is at least a 75% reduction in the modified PASI score from baseline, at week 16. The study will also determine the efficacy of different doses of ZL-1102 compared to placebo at the end of therapy. Secondary objectives include efficacy throughout the treatment period, safety, tolerability, pharmacokinetics and anti-drug antibody (ADA). For more information about this trial, please visit . About ZL-1102 ZL-1102 is an investigational, novel human VH antibody fragment, targeting the IL-17A cytokine, formulated as a hydrogel for topical use in the treatment of chronic plaque psoriasis. Due to its small size and other features unique to this class of molecules, ZL-1102 has improved target affinity and tissue penetration compared to full-sized monoclonal antibodies. With potentially improved safety and tolerability, this topical therapeutic may bring the potential of IL-17-targeted treatments to the large patient population with less severe CPP. About Mild-to-Moderate Chronic Plaque Psoriasis Plaque psoriasis is a common chronic, systemic, inflammatory autoimmune skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 125 million people worldwide. Plaque psoriasis is the most common type, affecting 80%-90% of those with psoriasis. 70–80% of plaque psoriasis cases are mild-to-moderate, and marketed IL-17 inhibitors are currently not indicated for such cases. Topical therapies are the standard of care for treatment of mild-to-moderate disease. However, current treatment options provide limited efficacy or have safety concerns with long-term use. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, autoimmune disorders, infectious disease and neuroscience. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, please visit or follow us at . Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements regarding the possible benefits, safety, and efficacy of ZL-1102; the treatment of chronic plaque psoriasis; and risks and uncertainties associated with drug development and commercialization. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC’s website at . Notes: (1) Sinclair, R., Sharifeh, S., Thackwray, S., Lickliter, J., Wu, J., Li, J., Qi, B., Bland-Ward, P., Reinhart, H. (2023). Topical application of a novel anti-interleukin-17A antibody fragment penetrates psoriasis skin: Results of a randomized, double-blind, placebo-controlled Phase IB study. June 28, 2023.