ISTA Pharmaceuticals, Inc.

Brings extensive experience in retinal and ophthalmology diseasesMELBOURNE, Australia and PRINCETON, N.J., April 08, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced the appointment of John Han, PharmD, to the role of Vice President, Medical Affairs, effective April 9, 2024. Dr. Han will report to Chief Executive Officer (CEO), Frederic Guerard, PharmD, and will join the Opthea Executive Management Team. Dr. Han brings over 20 years of experience building medical affairs programs and partnering across organizations to lead pre- and post-launch initiatives for medicines in ophthalmology and retinal disease. Over the course of his career, Dr. Han has served in senior leadership positions in medical and scientific affairs at leading biopharmaceutical companies. His career includes roles of increasing responsibility at Regeneron Pharmaceuticals, Inc., ISTA Pharmaceuticals, Chiron Corporation, Amgen Inc. and Bayer AG. He joins Opthea from Adverum Biotechnologies, Inc. where he led the development of the Medical Affairs function. “We are very pleased to welcome Dr. Han to the Opthea team. As we get close to completing the enrollment in our second Phase 3 trial (ShORe) with sozinibercept in wet AMD, we are initiating our launch preparations,” said Dr. Guerard, CEO of Opthea. “Dr. Han’s established track record of defining and executing effective medical affairs strategies and supporting pre-launch activities of new therapies for patients with retinal disease will be invaluable to the potential success of sozinibercept.” Dr. Han commented, “Most of my career in medical affairs has been dedicated to developing and launching transformational products in ophthalmology and retinal diseases. As a result of this work, I have a firsthand understanding of the incredible challenges faced by patients with wet AMD. The opportunity to contribute to the development of a groundbreaking therapy that has the potential to be the first product in more than 15 years to provide superior and meaningful visual outcomes in patients is what brought me to Opthea. As we work towards the release of top line results for the sozinibercept Phase 3 program in mid-2025, I look forward to working with this incredibly dedicated team to bring this product candidate to patients.” About John Han, PharmD Dr. Han brings over 25 years in the biopharmaceutical industry, mainly focused on product development in ophthalmology. Dr. Han has a proven track record of success in supporting several product introductions, including launch of EYLEA® for multiple retinal indications. He has held prominent leadership positions and roles of increasing responsibilities in organizations such as Adverum, Regeneron Pharmaceuticals, Inc, Amgen, Inc., Chiron Corporation, ISTA Pharmaceuticals, Inc. and Bayer AG, spanning therapeutic areas in ophthalmology, oncology, cardiology, and metabolism, working with small molecules, biologics, and gene therapies. Dr. Han earned a PharmD from the University of California, San Francisco School of Pharmacy (UCSF) and a Bachelor of Arts degree in microbiology and immunology from the University of California, Berkeley. Dr. Han completed his residency at the Veterans Affairs Medical Center in Sepulveda and held clinical and academic appointments at the Southern California System of Clinics, Sepulveda, UCSF School of Pharmacy and the University of Southern California School of Pharmacy prior to working in industry. About Opthea Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate, sozinibercept, is being evaluated in two pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents. To learn more, visit our website and follow us on X and LinkedIn. EYLEA® is a registered trademark of Regeneron Pharmaceuticals, Inc. Inherent risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Forward-looking Statements This ASX announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding rapidly advancing the registrational program for sozinibercept in wet AMD, expectations regarding the pivotal growth phase of Opthea, and the ability of sozinibercept to enhance vision outcomes for patients worldwide. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept safety, tolerability and therapeutic efficacy, additional analysis of data from Opthea’s Phase 3 clinical trials, timing of completion of the ShORe clinical trial patient enrollment and clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on September 28, 2023, Opthea’s 2024 Half Year Report included as an exhibit to the Form 6-K filed with the SEC on February 29, 2024, and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law. Authorized for release to ASX by Fred Guerard, CEO Investor EnquiriesPJ KelleherLifeSci Advisors, LLCEmail: pkelleher@lifesciadvisors.comPhone: 617-430-7579 MediaSilvana Guerci-LenaNorthStream Global PartnersEmail: silvana@nsgpllc.com Join our email database to receive program updates:Tel: +61 (0) 3 9826 0399Email: info@opthea.com Source: Opthea Limited

MELBOURNE, Australia and PRINCETON, N.J., April 08, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced the appointment of John Han, PharmD, to the role of Vice President, Medical Affairs, effective April 9, 2024. Dr. Han will report to Chief Executive Officer (CEO), Frederic Guerard, PharmD, and will join the Opthea Executive Management Team. Dr. Han brings over 20 years of experience building medical affairs programs and partnering across organizations to lead pre- and post-launch initiatives for medicines in ophthalmology and retinal disease. Over the course of his career, Dr. Han has served in senior leadership positions in medical and scientific affairs at leading biopharmaceutical companies. His career includes roles of increasing responsibility at Regeneron Pharmaceuticals, Inc., ISTA Pharmaceuticals, Chiron Corporation, Amgen Inc. and Bayer AG. He joins Opthea from Adverum Biotechnologies, Inc. where he led the development of the Medical Affairs function. “We are very pleased to welcome Dr. Han to the Opthea team. As we get close to completing the enrollment in our second Phase 3 trial (ShORe) with sozinibercept in wet AMD, we are initiating our launch preparations,” said Dr. Guerard, CEO of Opthea. “Dr. Han’s established track record of defining and executing effective medical affairs strategies and supporting pre-launch activities of new therapies for patients with retinal disease will be invaluable to the potential success of sozinibercept.” Dr. Han commented, “Most of my career in medical affairs has been dedicated to developing and launching transformational products in ophthalmology and retinal diseases. As a result of this work, I have a firsthand understanding of the incredible challenges faced by patients with wet AMD. The opportunity to contribute to the development of a groundbreaking therapy that has the potential to be the first product in more than 15 years to provide superior and meaningful visual outcomes in patients is what brought me to Opthea. As we work towards the release of top line results for the sozinibercept Phase 3 program in mid-2025, I look forward to working with this incredibly dedicated team to bring this product candidate to patients.” About John Han, PharmD Dr. Han brings over 25 years in the biopharmaceutical industry, mainly focused on product development in ophthalmology. Dr. Han has a proven track record of success in supporting several product introductions, including launch of EYLEA® for multiple retinal indications. He has held prominent leadership positions and roles of increasing responsibilities in organizations such as Adverum, Regeneron Pharmaceuticals, Inc, Amgen, Inc., Chiron Corporation, ISTA Pharmaceuticals, Inc. and Bayer AG, spanning therapeutic areas in ophthalmology, oncology, cardiology, and metabolism, working with small molecules, biologics, and gene therapies. Dr. Han earned a PharmD from the University of California, San Francisco School of Pharmacy (UCSF) and a Bachelor of Arts degree in microbiology and immunology from the University of California, Berkeley. Dr. Han completed his residency at the Veterans Affairs Medical Center in Sepulveda and held clinical and academic appointments at the Southern California System of Clinics, Sepulveda, UCSF School of Pharmacy and the University of Southern California School of Pharmacy prior to working in industry. About Opthea Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate, sozinibercept, is being evaluated in two pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents. To learn more, visit our website and follow us on X and LinkedIn. EYLEA® is a registered trademark of Regeneron Pharmaceuticals, Inc. Inherent risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Forward-looking Statements This ASX announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding rapidly advancing the registrational program for sozinibercept in wet AMD, expectations regarding the pivotal growth phase of Opthea, and the ability of sozinibercept to enhance vision outcomes for patients worldwide. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept safety, tolerability and therapeutic efficacy, additional analysis of data from Opthea’s Phase 3 clinical trials, timing of completion of the ShORe clinical trial patient enrollment and clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on September 28, 2023, Opthea’s 2024 Half Year Report included as an exhibit to the Form 6-K filed with the SEC on February 29, 2024, and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law. Authorized for release to ASX by Fred Guerard, CEO Investor Enquiries PJ Kelleher LifeSci Advisors, LLC Email: pkelleher@lifesciadvisors.com Phone: 617-430-7579 Media Silvana Guerci-Lena NorthStream Global Partners Email: silvana@nsgpllc.com Join our email database to receive program updates: Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Source: Opthea Limited

编者按：本文来自药智头条，作者葵花籽；赛柏蓝授权转载，编辑yuki“专利悬崖”意指药品专利保护期届满后，其销售额与利润大幅下滑的现象。此种现象如同一道无形的悬崖，原研药即便在光辉成就之下，亦无法回避这一严峻现实。对于原研药企而言，在寻求新增长点与巩固专利“护城河”的过程中，均面临着诸多挑战。利拉鲁肽、达沙替尼、那他珠单抗等多款年销售额超5亿美元的大品种都将在今年先后失去美国专利保护。2024年在美专利到期的十大药物资料来源：Fierce Pharma01 达沙替尼（Sprycel）适应症：慢性粒细胞白血病研发企业：BMS2023年美国销售额：14.5亿美元生物类似药上市时间：2024年9月达沙替尼是百时美施贵宝（BMS）肿瘤学主打产品之一，是一种针对癌细胞中特定蛋白质并阻止癌细胞生长的药物。BMS财报显示，达沙替尼2023年全球销售额约为19.3亿美元，其中14.5亿美元来自美国市场。达沙替尼于2006年首次获FDA批准，用于对先前治疗药物（包括伊马替尼）具有耐药性或不耐受的费城染色体阳性慢性髓系白血病慢性期（Ph+CML-CP）成人患者以及用于对先前治疗药物具有耐药性或不耐受的Ph+ALL成人患者。BMS在一份年度证券文件中解释说，由于与Apotex和一些未披露名称的公司达成了和解协议，某些仿制药获准在2024年9月上市，或在某些情况下提前上市。据悉，目前Teva、Biocon、Lupin、Dr.Reddy's Laboratories、Alebmic的仿制药已获得FDA暂定批准。02那他珠单抗（Tysabri）适应症： 多发性硬化症、克罗恩病研发企业：渤健2023年美国销售额：9.98亿美元生物类似药上市时间：2024年下半年那他珠单抗于2004年获得FDA批准用于治疗多发性硬化症，2008年获批用于治疗克罗恩病。该药在2009年销售额高达11亿美元。根据渤健2023年第四季度财报，2023年该药在美国的销售额为9.98亿美元，较2022年的11.2亿美元下降约11%。在特拉华州联邦法院驳回百健对山德士的专利侵权诉讼约两个月后，山德士于2023年8月获得了美国首个、也是迄今为止唯一一个那他珠单抗生物类似药的批准。03米拉贝隆（Myrbetriq）适应症：膀胱过度活动症研发企业：安斯泰来2023年美国销售额：6.4亿美元生物类似药上市时间：2024年5月2012年6月，米拉贝隆在美国获批上市。2023年6月，美国特拉华州地区法院作出裁决，宣布该药2030年的一项关键专利无效，这促使安斯泰来公开回应，并强调该药在2024年5月前仍受专利保护。不久之后，安斯泰来又获得了一项2030年的膀胱过度活动症药物专利，并发起了新一轮针对仿制药公司的诉讼。安斯泰来寻求获得FDA禁令，禁止生物类似药在该专利到期前上市。FDA的桔皮书显示，米拉贝隆的监管专属期将于2024年9月到期。该药的部分专利将于2024年5月到期。与此同时，Lupin和Alkem两家公司的米拉贝隆仿制药已获得FDA批准，此外，Aurobindo的仿制药也获得了初步批准。04利拉鲁肽（Victoza）适应症：2型糖尿病研发企业：诺和诺德2023年美国销售额：5.25亿美元生物类似药上市时间：2024年6月作为诺和诺德第一代GLP-1糖尿病药物，利拉鲁肽自2010年获批以来已顺利享受了14年的独占期，包括将其专利悬崖延长至2024年的儿科独占期。目前，生物类似药竞争者Teva、山德士和晖致正急于蚕食利拉鲁肽已经日薄西山的销售额。根据诺和诺德2023年年度报告，2023年利拉鲁肽在美国的销售额为5.25亿美元，较2022年9.3亿美元大幅下降。根据美国证券交易委员会的一份文件，Teva、山德士和晖致为主要的仿制药公司。其中，Teva计划在2024年6月推出利拉鲁肽生物类似药。05Emflaza (deflazacort)适应症： 杜氏肌营养不良症研发企业：PTC Therapeutics2023年美国销售额：2.55 亿美元生物类似药上市时间：2024年2月在经历了之前的定价争议之后，PTC Therapeutics获批治疗杜氏肌营养不良症（DMD）的关键药物Emflaza已经面临着新的生物类似药竞争。印度Aurobindo公司在2024年2月获得FDA最终批准后，正在计划推出Emflaza生物类似药，该药的标签范围涵盖了5岁及以上患者。06注射用醋酸奥曲肽微球 (Sandostatin LAR) 适应症：肢端肥大症，类癌瘤引起的严重腹泻研发企业： 诺华2023年美国销售额：1.99 亿美元仿制药上市时间：2024年Sandostatin LAR于1998年首次获得FDA批准治疗肢端肥大症，还可用于治疗转移性类癌引起的严重腹泻和潮红。晖致总裁Rajiv Malik在今年1月举行的摩根大通医疗保健会议上表示，将Sandostatin LAR列为今年计划推出的仿制药之一。根据晖致最新消息，Sandostatin LAR仿制药申请正在接受FDA审查。虽然Sandostatin LAR此前一直保持着美国的独家经营权，但其销售额已逐年大幅下降。去年Sandostatin在美国的销售额为1.99亿美元，同比下降2%。07Dulera (糠酸莫米松+福莫特罗)适应症： 哮喘研发企业：欧加隆2023年美国销售额：1.56 亿美元仿制药上市时间：2024年下半年Dulera是一款皮质类固醇糠酸莫米松和长效β受体激动剂福莫特罗的复方制剂，通过吸入器给药。Dulera曾被视为潜在的“重磅炸弹”，2010年获批用于治疗哮喘，但2012年治疗慢性阻塞性肺病（COPD）的第二次申请遭 FDA拒批。尽管获批折戟，但其销售额仍呈上升趋势，2015年达到5.36亿美元的峰值。到2017年，由于价格竞争压力以及需求下降，Dulera的销售额缩水至2.87亿美元。2023年更是骤降至1.56亿美元。Dulera已于2020年失去了在美国的专利保护，但至今未有相关仿制药上市。印度仿制药巨头Lupin曾于2020年4月向FDA递交了Dulera仿制药的上市申请，但其申请在2022年底被FDA拒绝批准。上个月，该公司表示将在2024年5月之前对FDA的决定做出回应。08奥卡西平 (Oxtellar XR）适应症： 癫痫研发企业：Supernus Pharmaceuticals2023年美国销售额：1.13 亿美元仿制药上市时间：2024年9月2012年，奥卡西平作为辅助疗法获得批准后销售额逐年攀升；2019年，奥卡西平作为单药疗法获批，销售额继续增长，2021年首次突破1亿美元，2023年在美国的销售额为1.13亿美元。十年前，Actavis和TWi Pharma首次对奥卡西平发出仿制药挑战。Supernus分别于2017年和2018年在针对仿制药生产商的侵权案中胜诉，因为法院判决其专利期有效至2027年。奥卡西平失去专利保护对其的影响并不大。在2月份的季度电话会议上，Supernus首席执行官Jack Khattar表示，预计仿制药竞争要到9月份才会开始。2024年奥卡西平和Trokendi XR的合并净销售额将在1.25亿美元到1.35亿美元之间。09Venofer (蔗糖铁)适应症：慢性肾病患者缺铁性贫血研发企业：CSL2023年美国销售额：0.9亿美元仿制药上市时间：2024年Venofer于2000年获得FDA批准用于治疗慢性肾病成人患者的缺铁性贫血。多年来，Venofer一直在回击潜在的仿制药挑战者。晖致在2月的投资者推介会上称其Venofer仿制药正在接受监管审查。CSL在2021年底以117亿美元收购Vifor Pharma时获得该药，据CSL投资者报告，该药物2023年的全球销售额为1.8亿美元，预计其中二分之一来自美国市场。10Prolensa (bromfenac)适应症：白内障手术后的术后眼部炎症研发企业：Bausch + Lomb2023年美国销售额：0.415亿美元仿制药上市时间：2024年1月FDA于2013年批准Bausch+Lomb的Prolensa滴眼液作为白内障手术患者术后炎症的治疗药物，但它并不是第一款进入美国市场的含有非甾体抗炎药物溴芬酸活性成分的滴眼液产品。Prolensa最初是由日本公司Senju开发，2000年在日本上市。ISTA公司于 2002年获得该药在美国的使用权，ISTA后来被Bausch+Lomb收购。2005年，该产品在美国获批上市，商品名为Xibrom（溴芬酸0.09%），作为白内障手术后眼部炎症的每日2次滴眼液选择。2010年，ISTA开发的溴芬酸的每日1次滴眼液版本Bromday获批上市。在Prolensa获得FDA批准的同一年，Lupin曾向FDA提交溴芬酸的仿制药上市申请。经历了长达近3年的诉讼后，Lupin仿制药于2023年11月获得FDA 批准。除了Lupin之外，Metrics、Innopharma、Apotex和Paddock也向FDA提交了Prolensa的仿制药上市申请。END内容沟通：13810174402医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联