Teriflunomide

NEW YORK, Nov. 21, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced it ranked number one on the Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 30th year. The Company’s growth between fiscal years 2020 to 2023 was fueled by BRIUMVI® revenues, which was approved to treat adult individuals with relapsing forms of multiple sclerosis in December of 2022. Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, “We are proud to be recognized as the fastest-growing company in North America on the Deloitte Technology Fast 500 list. This recognition reflects the unwavering commitment of our incredible team and the strong success in bringing BRIUMVI to people with relapsing forms of multiple sclerosis. As we continue our mission to develop and provide treatment alternatives for those in need, we are grateful for the trust and support we have received from the multiple sclerosis community.” About the 2024 Deloitte Technology Fast 500Now in its 30th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2020 to 2023. In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company’s operating revenues. Companies must have base-year operating revenues of at least US$50,000, and current-year operating revenues of at least US$5 million. Additionally, companies must be in business for a minimum of four years and be headquartered within North America. About DeloitteDeloitte provides industry-leading audit, consulting, tax and advisory services to many of the world’s most admired brands, including nearly 90% of the Fortune 500® and more than 8,500 U.S.-based private companies. At Deloitte, we strive to live our purpose of making an impact that matters by creating trust and confidence in a more equitable society. We leverage our unique blend of business acumen, command of technology, and strategic technology alliances to advise our clients across industries as they build their future. Deloitte is proud to be part of the largest global professional services network serving our clients in the markets that are most important to them. Bringing more than 175 years of service, our network of member firms spans more than 150 countries and territories. Learn how Deloitte’s approximately 460,000 people worldwide connect for impact at www.deloitte.com. ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn. BRIUMVI® is a registered trademark of TG Therapeutics, Inc. ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IVBRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. A list of authorized specialty distributors can be found at www.briumvi.com. IMPORTANT SAFETY INFORMATION Contraindications: BRIUMVI is contraindicated in patients with: Active Hepatitis B Virus infectionA history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface premedantigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com. ABOUT BRIUMVI PATIENT SUPPORT BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com. ABOUT MULTIPLE SCLEROSIS Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1 ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn. BRIUMVI® is a registered trademark of TG Therapeutics, Inc. Cautionary StatementThis press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward looking statements include but are not limited to statements regarding expectations for the commercial launch of BRIUMVI® (ublituximab-xiiy) for RMS in the United States; and anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications. Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to maintain a commercial infrastructure for BRIUMVI, and to successfully market and sell BRIUMVI; the risk that the Company’s BRIUMVI U.S. net revenue targets will not be achieved; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variation from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for its clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in our other filings with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor Relations: Email: ir@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 4Media Relations: Email: media@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.

近年来，神经学药物市场持续充满活力，新的治疗方法迎合了广泛的神经和精神疾病治疗需求。 2023年神经学领域畅销药TOP20榜单显示，神经学药物最高销售额达71亿美元，有7个品种年销售额均超20亿美元。 >01< 神经学领域畅销药TOP20 从榜单来看（下表1），TOP20药物中有18个品种在2023年全球销售额达到10亿美元，其中2个年销售额超过50亿美元。 表1 2023年神经学畅销药TOP20 数据来源：xtalks 注：由于货币汇率波动，销售额换算统一货币时略有差异。 罗氏的奥瑞利珠单抗在2023年销售额达到71.03亿美元，夺得神经学领域药物“药王”宝座，今年上半年奥瑞利珠单抗药销售额继续实现一位数增长，达到33.59亿美元，同比增长5%。目前，排名前七的药物半年销售额均超过20亿美元，且其中5个品种实现两位数的同比增长率，未来仍有不少增长空间。 值得一提的是，辉瑞旗下的偏头痛药物瑞美吉泮在2023年销售额同比大增335.6%，达到9.28亿美元，这一数据反映了该药物在市场上的强劲表现和需求增长。 从药物类别来看（下图2），小分子药物（75%）是主要的药物类型，其次为单抗（15%），基因疗法药物和其他蛋白药物占比10%。 图1 2023年神经学畅销药分类 数据来源：公开资料整理 从适应症来看（下图3），这20款药物适应症主要集中在多发性硬化症（6款）和精神分裂症（5款）上面，分别占比30%和25%，由此可见这两种药物具有广泛的市场需求。 图2 2023年神经学畅销药适应症分布 数据来源：公开资料整理 >02< 罗氏持续领跑 2023年神经学领域药物全球销售总额排名前三的企业分别是罗氏（87.49亿美元）、艾伯维（84.32亿美元）和诺华（51.96亿美元）。 罗氏凭借2款产品（奥瑞利珠单抗和利司扑兰）在神经学药物领域持续领跑，其中Ocrevus（奥瑞利珠单抗）是一种cd20导向的细胞溶解抗体，用于治疗复发型多发性硬化症，包括临床孤立综合征、复发缓解型疾病和活动性继发进行性疾病，以及成人原发性进行性多发性硬化症。 这是首个也是唯一被批准用于治疗重度致残性多发性硬化症的疾病改善疗法，也被批准用于治疗复发性多发性硬化症（RMS）。在RMS中，Ocrevus被证明优于Rebif（干扰素β-1a），一种常用的RMS疗法，在一项临床研究中，Ocrevus是第一个也是唯一一个在中位治疗时间为三年的PPMS中显著减缓进展的治疗方法。 根据罗氏2023年年度报告，Ocrevus的销售额约为71亿美元，增长12.3%，其中包括美国新患者和保留患者的11%增长。另一款产品用于治疗小儿和成人脊髓性肌萎缩症（SMA）的Evrysdi（利司扑兰)。Evrysdi是第一种口服药物，也是第二种被批准用于治疗SMA的药物。Evrysdi2023年全球销售额为16.46亿美元，增长34.6%。 罗氏堪称TOP药企里的“造星之王”。当前，罗氏在神经领域的研发侧重于神经肌肉疾病、神经免疫性疾病、神经退行性疾病与神经发育性疾病等亚专科领域，涵盖帕金森病、阿尔茨海默病、多发性硬化、视神经脊髓炎谱系疾病、重症肌无力、脊髓性肌萎缩症等疾病，如Trontinemab、奥瑞利珠单抗、萨特利珠单抗、利司扑兰都是不同疾病领域内的代表性药物。在其现有的87个新化合物和65个附加适应症临床管线当中，神经学管线布局（20项）规模仅次于肿瘤（43项），且远超其他领域。 >03< 多款MS药物发力 多发性硬化（MS）是一种免疫介导的中枢神经系统炎性脱髓鞘疾病，其病变具有时间多发与空间多发的特征。在过去的10年中，MS在流行病学、病理学、疾病活动与进展等领域的相关研究推动了该病临床分型、诊断标准、治疗目标的更新，新的疾病修正治疗药物也为治疗策略提供了更多选择。 从榜单来看，TOP20药物中有6款产品用于治疗多发性硬化症，分别是Ocrevus(奥瑞利珠单抗)、Kesimpta（奥法妥木单抗）、Tysabri（那他珠单抗）、Gilenya（芬戈莫德）、Aubagio（特立氟胺）和Tecfidera（富马酸二甲酯）。 其中，来自诺华的Kesimpta 2023年全球销售额达21.71亿美元，同比增长99%，成为诺华增长主力。Kesimpta因其强大的疗效和良好的安全性而脱颖而出，并提供了在家自我给药的便利。截至2024年10月22日，该药物是全球唯一一款可通过每月一次居家自行管理的B细胞靶向疗法。 该药物MS适应症在美国获批上市次年（2021年），同适应症即在中国获批上市，作为“优先审批类别”，诺华以最快的速度，实现产品在中国与欧美国家的同步上市。2024年10月30日，诺华发布2024年第三季度财报，Kesimpta这款用于治疗多发性硬化症的药物继续表现优异，2024年第三季度销售额飙升至8.38亿美元，同比增长28%，推动诺华在免疫领域的收入。 >04< 结语 众多药企对神经学药物市场的重视将导致竞争愈发激烈。一方面，大型药企凭借其丰富的资源和研发经验，将继续巩固在市场中的地位，如罗氏、艾伯维等公司可能会进一步拓展其神经学药物产品线和适应症范围。另一方面，小型药企和生物科技公司可能会通过聚焦细分领域或开发创新性药物来寻求突破，市场可能会逐渐分化为头部企业占据主要市场份额，而特色鲜明的小型企业在特定领域或小众适应症中崭露头角。神经学药物市场未来发展如何？我们拭目以待。 参考资料 1.https://xtalks.com/top-20-best-selling-neurology-drugs-to-watch-in-2024-3931/ 2.药智数据 3.各种企业官微、官网及公开资料 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。 责任编辑 | 史蒂文 转载开白 | 马老师 18996384680（同微信） 商务合作 | 王存星 19922864877（同微信）  阅读原文，是受欢迎的文章哦