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东营市人民医院召开药物临床试验项目启动会
Qi Lu Wan Bao Wang· 2025-06-10 09:39
6月3日,东营市人民医院(山东省立医院集团东营医院)心血管内科召开"一项在近期有急性心肌梗死病 史的受试者中评估自行皮下注射selatogrel预防全因死亡和治疗急性心肌梗死有效性和安全性的多中心、 随机、双盲、安慰剂对照、平行分组研究"启动会。 此次启动会的成功召开,彰显了东营市人民医院在心血管疾病领域的临床研究实力。医院药物临床试验 机构将继续秉持科学严谨的态度,深化国内外科研合作,推动临床研究规范化建设,为提升医院综合实 力和学科影响力注入新动力。(大众新闻记者巩奕含) 本研究的主要目的是评估有急性心肌梗死(AMI)复发风险的受试者发生提示AMI症状后自行给予 selatogrel的临床有效性。启动会由山东省立医院派驻心血管内科名誉主任韩伟中主持。药物临床试验机 构办公室主任李振卿及成员、心血管内科专业研究团队、CRO代表等相关人员参加启动会议。此项目 是东营市人民医院心血管内科启动的首个注册类全球多中心药物临床试验,该项目由韩伟中担任主要研 究者。 会上,CRA就项目研究背景、方案研究设计、入选标准、排除标准、疗效指标、安全性指标、给药方 案等内容,从临床试验情况、研究评估指标、禁忌伴随用药、知情同意 ...
Viatris (VTRS) FY Conference Transcript
2025-06-09 15:40
Summary of Viatris (VTRS) FY Conference Call - June 09, 2025 Company Overview - **Company**: Viatris (VTRS) - **Key Executives Present**: Scott Smith (CEO), Doretta Mistras (CFO), Corinne Lagoff (CCO), Philippe Martin (Head of R&D) [2][3] Core Industry Insights - **Industry**: Pharmaceutical and Biotechnology - **Market Dynamics**: Viatris operates in a competitive landscape with a focus on both branded (60%) and generic (40%) products, with a significant portion of branded products being past loss of exclusivity (LOE) [11][12] Key Points and Arguments 1. **Base Business Performance**: The base business is described as strong, with eight to nine consecutive quarters of operational revenue growth, despite some manufacturing issues at the Indoor plant [4][6] 2. **Capital Allocation Strategy**: Viatris has been actively buying back shares, totaling over $300 million, while also focusing on dividends and business development [5][63] 3. **Pipeline Development**: The company has a robust pipeline with 11 programs in Phase III, all showing positive results, including products for anxiety, pain, and eye care [6][10] 4. **Strategic Review**: An enterprise-wide strategic review is underway to optimize operations and ensure the right personnel are in place for future growth [7][9] 5. **FDA Resubmission**: The Indoor facility is on track for FDA re-inspection mid-year, with remediation efforts progressing ahead of schedule [8][32] 6. **Tariff Concerns**: Potential pharmaceutical tariffs could impact the generic market significantly, with 90% of dispensed products being generics, yet only accounting for 1% of total healthcare costs [19][22] 7. **Impact of Legislation**: The company has limited exposure to recent legislative changes, as 99% of its portfolio has gone through LOE, indicating minimal current impact but potential future considerations [30][31] 8. **Acute Pain Market Opportunity**: Viatris is developing a fast-acting meloxicam for acute pain, targeting a market of 70-80 million cases annually, with a significant unmet need for non-opioid treatments [43][44] 9. **Ocular Portfolio**: The company is expanding its eye care division, with recent positive Phase III data for a product addressing dim light disturbances post-surgery, indicating a potential first FDA-approved treatment for this condition [72][74] Additional Important Insights - **Market Size**: The acute pain market in the U.S. is valued at approximately $44 billion, highlighting the significant revenue potential for Viatris's new product [46] - **Patient Education**: For the emergency therapeutic option for heart attacks, Viatris is focusing on patient education to ensure timely self-administration of the treatment [60][61] - **Future Growth**: The company aims for sustainable revenue and EBITDA growth in 2026 and beyond, with a focus on innovative products and capital allocation strategies [10][12] This summary encapsulates the key themes and insights from the Viatris FY Conference Call, providing a comprehensive overview of the company's current status, strategic direction, and market opportunities.
Viatris(VTRS) - 2025 Q1 - Earnings Call Presentation
2025-05-08 11:15
Q1 2025 Earnings May 8, 2025 1 This document contains proprietary information of Viatris Inc. Unauthorized use, duplication, dissemination or disclosure to third parties is strictly prohibited. © 2025 Viatris Inc. All Rights Reserved. VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris company. Forward Looking Statements This presentation contains "forward-looking statements". These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of ...