Maia Pharmaceuticals, Inc.

Only ready-to-use liquid format of bivalirudin on the market Does not require reconstitution, dilution or mixing, which helps increase efficiency for hospitals and healthcare providers DUBLIN, July 18, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping bivalirudin injection in a ready-to-use 250 mg/50 mL single-use vial. It is the only ready-to-use liquid format of bivalirudin on the market in the U.S. "Hospital practitioners work hard to provide quality patient care while also meeting operational challenges," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "With ready-to-use products like bivalirudin, we're helping to deliver solutions that reduce complexity for healthcare providers—so they can focus on patient care." In May 2023, Endo executed agreements with MAIA Pharmaceuticals, Inc. and Gland Pharma Limited, India to commercialize ready-to-use bivalirudin in the U.S. The product, manufactured by Gland Pharma Limited, is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots. It is used to prevent blood clots in people with severe chest pain or other conditions who are undergoing an angioplasty procedure. Ready-to-use, or RTU, products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Bivalirudin injection is contraindicated in patients with: Significant active bleeding; Hypersensitivity to bivalirudin injection or its components WARNINGS AND PRECAUTIONS Bleeding Events Bivalirudin increases the risk of bleeding. Bivalirudin's anticoagulant effect subsides approximately one hour after discontinuation. Thrombotic Risk with Coronary Artery Brachytherapy An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of bivalirudin in gamma brachytherapy. ADVERSE REACTIONS The most common adverse reaction was bleeding (3.7%). DRUG INTERACTIONS In clinical trials in patients undergoing percutaneous coronary intervention (PCI), co-administration of bivalirudin with heparin, warfarin, thrombolytics, or GPls was associated with increased risks of major bleeding events compared to patients not receiving these concomitant medications. USE IN SPECIFIC POPULATIONS Geriatric Use In studies of patients undergoing PCI, 44% were ≥65 years of age and 12% of patients were ≥75 years old. Elderly patients experienced more bleeding events than younger patients. Renal Impairment The disposition of bivalirudin was studied in PTCA patients with mild, moderate and severe renal impairment. The clearance of bivalirudin was reduced approximately 21% in patients with moderate and severe renal impairment and was reduced approximately 70% in dialysis- dependent patients. The infusion dose of bivalirudin injection may need to be reduced, and anticoagulant status monitored in patients with renal impairment. INDICATION AND USAGE Bivalirudin injection is indicated for use as an anticoagulant in patients undergoing PCI, including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Please click for Full Prescribing Information. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Mr. Sims, any statements relating to product launch, efficiencies, commercialization, competition or sales, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. SOURCE Endo International plc

Only ready-to-use (RTU) liquid format of bivalirudin expected to begin shipping in summer 2023 RTU bivalirudin injection does not require reconstitution, dilution or mixing, which helps increase efficiency for hospitals and healthcare providers DUBLIN, May 24, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its subsidiary Endo Ventures Limited has executed an agreement with MAIA Pharmaceuticals, Inc. to distribute bivalirudin injection in a ready-to-use 250 mg/50 mL single-use vial in the U.S. Endo will commercialize the FDA-approved product through its Par Sterile Products business and expects to begin shipping in summer 2023. "Hospital providers have told us what they need—ready-to-use medications that allow them to focus on patients rather than preparation," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "Through this partnership with MAIA Pharmaceuticals, we are proud to answer that call with the only ready-to-use liquid format of bivalirudin." "Like Endo, MAIA is laser-focused on delivering meaningful solutions to support healthcare providers as they deliver quality patient care," said Brian Cooney, Sr. Director, Corporate Development at MAIA Pharmaceuticals. "We are pleased to partner with Endo to provide ready-to-use bivalirudin, which requires no reconstitution, no dilution and no mixing." Ready-to-use, or RTU, products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. About MAIA Pharmaceuticals Founded in 2013 and headquartered in Princeton, New Jersey, MAIA Pharmaceuticals is a specialty pharmaceutical company that identifies, develops, manufactures and markets innovative and niche generic products. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Messrs. Sims and Cooney, any statements relating to product launch, commercialization, sales, supply or distribution, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. Company Codes: OTC-BB:ENDPQ, OTC-PINK:ENDPQ, OtherOTC:ENDPQ

药讯精选GBI NEWS和铂医药/科伦博泰抗TSLP全人源单抗在华启动中重度哮喘临试和铂医药宣布，其与科伦博泰（科伦药业控股子公司）共同开发的新一代抗TSLP全人源单克隆抗体HBM9378（科伦博泰产品代号：SKB378）在中国的I期试验完成首例受试者给药，治疗中重度哮喘。HBM9378/SKB378由和铂医药和科伦博泰共同研发，双方共同享有其全球权益。根据战略合作协议，和铂医药和科伦博泰将共同开发单克隆抗体和抗体偶联药物的创新疗法。HBM9378/SKB378是一款由和铂医药双重链双轻链（H2L2）平台开发的全人源单克隆抗体。该抗体可靶向胸腺基质淋巴细胞生成素（TSLP），阻断该因子和受体的相互作用，从而抑制TSLP介导的信号通路。**戳文末“阅读原文”定制/订阅医疗行业新闻资讯复星医药与MAIA合作产品20毫升苯乙酸钠和苯甲酸钠 (SPSB)复方液体制剂在美国上市上海复星医药（集团）股份有限公司宣布，旗下位于美国的控股子公司Fosun Pharma USA Inc. 和总部位于美国普林斯顿的专业制药公司MAIA Pharmaceuticals, Inc.合作开发的20ml苯乙酸钠和苯甲酸钠（SPSB）复方液体制剂已于近期在美国上市。Fosun Pharma USA享有合作产品在美国市场的独家商业化权利。该合作产品是目前唯一一款获美国FDA批准的20 ml SPSB复方液体制剂。根据当地市场反馈，现有规格（50 ml）SPSB产品在使用中存在大量浪费，尤其在儿科领域，这对医疗健康系统来说是一笔巨大的成本负担，通过有效推广20ml规格的SPSB复方液体制剂有望进一步减少浪费。SPSB是一种氮结合剂，主要用于儿童和成人尿素循环酶缺乏患者的急性高氨血症和相关脑病辅助治疗。**戳文末“阅读原文”定制/订阅医疗行业新闻资讯企业动态GBI NEWS再鼎医药获得Seagen宫颈癌ADC药物TIVDAK大中华区独家权益 再鼎医药宣布与美国生物技术公司Seagen Inc.就抗体偶联药物 (ADC) TIVDAK（tisotumab vedotin-tftv）达成在中国内地、香港、澳门和台湾地区的开发和商业化的独家合作和许可协议。TIVDAK是首个且目前唯一在美国获批的，用于治疗在化疗期间或之后出现疾病进展的复发或转移性宫颈癌成人患者的ADC。根据协议条款，Seagen将获得3000万美元的预付款，另加开发、注册及商业化里程碑付款，以及TIVDAK在再鼎医药许可区域内的净销售额分级特许权使用费。TIVDAK由Genmab针对组织因子（TF）的人源单克隆抗体和Seagen的ADC技术组成，Seagen将和Genmab平均分配再鼎医药支付的预付款，里程碑式付款以及特许权使用费。**戳文末“阅读原文”定制/订阅新闻资讯绿叶制药与ICI Pakistan在巴基斯坦达成思瑞康分销与推广合作据报道，绿叶制药集团已与巴基斯坦公司ICI Pakistan达成合作，授予旗下思瑞康（富马酸喹硫平，速释）在巴基斯坦市场的独家分销和推广权。思瑞康用于治疗精神分裂症和双相情感障碍，获多国权威指南优选推荐。数据显示：南亚地区约有1.5亿至2亿人被诊断为精神疾病；其中，包括巴基斯坦在内的约0.6%南亚人口患有双相情感障碍，而精神分裂症的患病率在巴基斯坦达到约1.5%。2018年5月，绿叶制药以5.46亿美元（约合人民币34.77亿元）获阿斯利康思瑞康及思瑞康缓释片在51个国家和地区的的许可权利。此后绿叶制药在亚太地区、美洲、非洲的多个国家和地区与当地合作伙伴达成分销与推广战略合作，包括Cipla Ltd、Moksha8 Pharmaceuticals、Alvogen Korea Co., Ltd、Zuellig Pharma、DKSH、Alter Pharma以及Laboratorios Bago。**戳文末“阅读原文”定制/订阅新闻资讯默沙东授予国药集团莫诺拉韦中国境内经销权和独家进口权9月28日，默沙东宣布与国药集团签署合作框架协议。默沙东将其和Ridgeback公司合作研发的抗新冠病毒口服药物莫诺拉韦（molnupiravir）的经销权和独家进口权授予国药集团，同时双方将评估技术转让的可行性，以便该药物在中国境内生产、供应和商业化。莫诺拉韦是一款口服小分子新冠病毒治疗药物。全球范围内，莫诺拉韦已在美国、欧盟、澳大利亚、日本、韩国以及中国香港、中国台湾等超过40个国家或地区获得上市许可或紧急使用授权。截至2022年8月底，默沙东已向全球30多个市场供应超860万个疗程的莫诺拉韦药物，治疗了超过180万名患者。**戳文末“阅读原文”定制/订阅新闻资讯器械要闻GBI NEWS微创心通Alwide Plus球囊导管在哥伦比亚获批9月28日，微创心通医疗科技有限公司发布公告称，其自主研发的Alwide Plus球囊导管（“Alwide Plus”）已于哥伦比亚成功注册。Alwide Plus是微创心通Alwide球囊导管的升级二代产品，于2021年7月29日获国家药监局注册批准，并于2022年3月于阿根廷成功注册。其主要特点包括：①低顺应性能够实现更准确的球囊扩张尺寸；②高爆破压力适合严重钙化的病变；③快速充盈╱回抽可最大限度地减少起搏时间。与第一代产品相比，Alwide Plus旨在提升爆破压力。Alwide Plus可降低在TAVI（经导管主动脉瓣植入）手术中进行瓣膜预扩和后扩的难度。**戳文末“阅读原文”定制/订阅新闻资讯政策要闻GBI NEWS药监局发布第五十九批仿制药参比制剂目录9月28日，国家药监局发布第五十九批仿制药参比制剂目录，共新增67品规药品，含注射剂15品规；13品规既往批次药品信息修订，修订信息包括增加持证商、修订规格及药品通用名称等。**戳文末“阅读原文”定制/订阅新闻资讯近期活动GBI 20周年，感恩一路有你！为了更好地满足医疗同仁们工作中的实际需求，诚挚邀请您参加GBI产品满意度调研及免费体验活动：点击 阅读原文 参加感恩季福利调研活动