Hikma Pharmaceuticals Plc

10月8日，百奥泰宣布已与吉瑞医药（Gedeon Richter）就BAT2206（一款参照喜达诺®乌司奴单抗的生物类似药）签署授权许可及商业化协议，吉瑞医药将拥有BAT2206在欧盟、英国、瑞士、澳大利亚以及其他部分欧洲国家市场的独占的商业化权益。 根据协议条款，百奥泰将负责BAT2206的研发、生产以及商业化供应，吉瑞医药将负责BAT2206在欧盟、英国、瑞士、澳大利亚以及其他部分欧洲国家市场的商业化。百奥泰可获得总金额最高至1.1亿美元，其中包括850万美元首付款、累计不超过1.015亿美元里程碑付款，以及净销售额的两位数百分比作为收入分成。 BAT2206是百奥泰根据中国NMPA、美国FDA、欧洲EMA生物类似药相关指导原则开发的乌司奴单抗注射液。目前，BAT2206上市许可申请已获中国NMPA、美国FDA以及欧洲EMA受理。 乌司奴单抗是一款靶向白细胞介素IL-12和IL-23共有的p40亚基的全人源单克隆抗体。IL-12和IL-23是天然产生的细胞因子，能够参与炎症和免疫应答过程，可以与p40亚基以高亲和力特异性地结合，阻断其与细胞表面受体结合，从而破坏IL-12和IL-23介导的信号传导和细胞因子的效应。公开资料显示，乌司奴单抗原研产品由强生（Johnson & Johnson）公司研发，已经在全球范围内获批治疗斑块状银屑病、溃疡性肠炎等适应症。 百奥泰创始人及总经理李胜峰博士表示：“BAT2206乌司奴单抗是百奥泰一款重要的生物类似药，目前已向中美欧三地递交上市申请且均已获得受理。我们很高兴能够与吉瑞医药达成合作，相信吉瑞医药是我们合适的合作伙伴，我们将一同把BAT2206带到欧洲市场，惠及更多有需要的患者。” 吉瑞医药是总部位于布达佩斯的一家制药和生物技术企业。该公司的产品组合涵盖多个重要的治疗领域，包括妇女保健、中枢神经系统和心血管领域。 值得一提的是，此前于2021年，百奥泰还宣布与Hikma Pharmaceuticals达成协议，将BAT2206在美国市场的独家商业化权益授予后者，百奥泰可获得2000万美元的首付款，以及最高达1.3亿美元的开发和商业化里程碑付款。 参考资料： [1] 百奥泰与吉瑞医药就BAT2206（一款参照喜达诺®乌司奴单抗开发的生物类似药）签署欧盟、英国、瑞士等市场的授权许可及商业化协议. Retrieved Oct 09, 2024, from https://mp.weixin.qq.com/s/wV7YYoz0FMizEv6E5McCIA 内容来源于网络，如有侵权，请联系删除。

DUBLIN--( BUSINESS WIRE )--The "Intranasal Drug Delivery - Global Strategic Business Report" has been added to ResearchAndMarkets.com's offering. The global market for Intranasal Drug Delivery is estimated at US$59.1 Billion in 2023 and is projected to reach US$92.6 Billion by 2030, growing at a CAGR of 6.6% from 2023 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The growth in the intranasal drug delivery market is driven by several factors, including advancements in delivery technologies, increasing prevalence of chronic and acute conditions requiring rapid intervention, and a growing preference for non-invasive administration methods among patients and healthcare providers. Technological innovations, such as improved formulations and novel delivery devices, enhance drug stability and absorption, expanding the range of treatable conditions. Additionally, demographic trends such as aging populations and rising incidences of conditions like Alzheimer's disease and Parkinson's disease fuel demand for more effective drug delivery systems. Consumer behavior shifts towards self-administration and home care, coupled with healthcare cost containment strategies, further propel market expansion. The development of intranasal vaccines, particularly highlighted by the COVID-19 pandemic, also underscores the critical role of this delivery method in global health strategies. Key Insights: Market Growth: Understand the significant growth trajectory of the Liquid Delivery Devices segment, which is expected to reach US$38.0 Billion by 2030 with a CAGR of a 6.2%. The Powder Delivery Devices segment is also set to grow at 7.5% CAGR over the analysis period. Regional Analysis: Gain insights into the U.S. market, estimated at $24.6 Billion in 2023, and China, forecasted to grow at an impressive 8.9% CAGR to reach $8.1 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific. Report Features: Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2023 to 2030. In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa. Company Profiles: Coverage of major players such as Acorda Therapeutics, Inc., Ferring Pharmaceuticals Inc, Bespak Europe Ltd., and more. Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments. Key Attributes: Report Attribute Details No. of Pages 459 Forecast Period 2023 - 2030 Estimated Market Value (USD) in 2023 $59.1 Billion Forecasted Market Value (USD) by 2030 $92.6 Billion Compound Annual Growth Rate 6.6% Regions Covered Global Key Topics Covered: MARKET OVERVIEW Influencer Market Insights World Market Trajectories Intranasal Drug Delivery - Global Key Competitors Percentage Market Share in 2024 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2024 (E) Intranasal Drug Delivery: A Prelude Leading Indications and APIs Amenable to Nasal Drug Delivery Regional Market Analysis Why Nasal Application is Garnering Notable Attention for Drug Delivery Limitations of Intranasal Drug Delivery Overview of the Traditional Drug Administration Routes, Molecular Weight Capabilities, and Dosage Range Drug Delivery Pathways Related to the Nasal Cavity Systemic delivery and Local Delivery Routes Differences between Systemic Delivery and Local Effects Challenges Involved In Formulating Nasal Drugs Intranasal Cavity: An Attractive Drug Delivery Route to Cross the Blood Brain Barrier Nose-to-Brain Drug Delivery: An Evolving Area of Interest Factors Inhibiting Nose-to-Brain Transportation of Drugs Bioavailability: An Important Facet of Intranasal Drug Delivery Traditional Vs. Advanced Intranasal Drug Formulation Types Type of Nasal Delivery Vehicles with Select Therapeutic Agents and Area of Application Select FDA-Approved Nasal Products Compound (Trade Name) Indication Dosage Form Year Recent Market Activity MARKET TRENDS & DRIVERS Rise in Prevalence of COPD Drives Opportunities Global Prevalence of COPD: Percentage of Men and Women Affected by Age Group Pharmaceutical and Medical Device Companies Vie to Develop New Intranasal Therapeutics for Allergic Rhinitis Patients Prevalence Percentage of COPD, Asthma, and Allergic Rhinitis for Select Countries The US - FDA Approved Intranasal Corticosteroids (INAC) and Intranasal Antihistamines (INAH) for Treating Allergic Rhinitis The US - FDA Approved Nasal Spray Medication Types (excluding INAC & INAH) for Allergic Rhinitis Treatment Intranasal Corticosteroids : A Potential Treatment for Debilitating Chronic Rhinosinusitis Disease Select Intranasal Corticosteroid Brands for Adult and Pediatric Usage Manufacturers Focus on Improved Nasal Delivery Platforms Controlled Release Technology is the Buzz Word Research on Nanocarrier-Based Intranasal Drug Delivery Systems Picks Up Pace Potential Role in Treatment and Management of Coronavirus Infection Self-Administration of Drugs Brings Intranasal Drug Delivery into the Spotlight Nasal Drug Delivery Offers New Opportunities for Drug Developers as Patent Cliffs Usher in Dusk of Blockbuster Era Active Pharmaceutical Ingredients Used in Formulations for Nasal Drug Delivery with Related Indications Increasing R&D Unlocks New Therapeutic Areas for Nasal Drug Delivery Intranasal Therapeutics Delivery: A High Potential Method for Treating CNS Diseases Researchers Develop Nasal Spray Treatment for Parkinson's Disease Future Opportunities in CNS Space Intranasal Delivery of Stem Cells: A Primary Strategy for Treatment of CNS Disorders Intranasal Delivery of Stem Cells: Limitations Diagnosed Prevalence Cases of Parkinson's Disease Across Select Countries Intranasal Delivery of Peptide-Based Pharmaceuticals Select Protein, Peptide & Non-Peptide Drugs Available as Nasal Spray Solutions in the Marketplace Select List of Nasal Biologics Available in the Market Benefits of Bi-Directional Nasal Drug Delivery Rise in Interest in Preservative-free Nasal Spray Formulations Burgeoning Geriatric Populace Spurs Growing Demand for Intranasal Drug Therapies FOCUS ON SELECT PLAYERS (Total 77 Featured) Acorda Therapeutics, Inc. Ferring Pharmaceuticals Inc Bespak Europe Ltd. Breckenridge Pharmaceutical, Inc. Janssen Global Services LLC Hikma Pharmaceuticals PLC Biologische Heilmittel Heel GmbH Evoke Pharma, Inc. KemPharm, Inc. Impel NeuroPharma Actiza Pharmaceutical Pvt., Ltd. Covis Pharma H&T Presspart Manufacturing Ltd. Biomedica International Alchemy Pharmatech Ltd. For more information about this report visit https://www.researchandmarkets.com/r/4lr0vg About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

THURSDAY, Sept. 5, 2024 -- The maker of the ADHD drug Vyvanse has been given approval by the U.S. Drug Enforcement Administration to make more of the medication as a shortage of the critical drugs continues. Following a request from the U.S. Food and Drug Administration in July, the DEA said Thursday that Takeda Pharmaceuticals may now increase its production limit by 24%. “These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine [Vyvanse] to meet legitimate patient needs both domestically and globally,” the DEA said in a notice it posted on the approval. ADHD drugs have been in short supply for years. The FDA first warned of a shortage of Teva Pharmaceutical Industries’ Adderall medication in October 2022, as the company was plagued by manufacturing delays. That prompted a spike in demand and subsequent shortage of Takeda’s Vyvanse. Why was the DEA's approval to boost production needed? Vyvanse (lisdexamfetamine) is classified by the DEA as a schedule II controlled substance, which is applied to drugs considered to have a high likelihood of being abused, so additional prescribing safeguards are put in place. The production limit for lisdexamfetamine was increased by 13, 478 pounds (6,236 kilograms), which includes 3,434 pounds (1,558 kg) to address domestic demand and 10,313 pounds (4,678 kg) for foreign demand for finished dosage medications, according to the DEA. After Takeda lost exclusivity of Vyvanse last year, the FDA approved generic versions of Vyvanse from 11 drugmakers, including U.S.-based drugmakers Mallinckrodt and Viatris, UK-based Hikma Pharmaceuticals and Indian drugmaker Sun Pharmaceutical Industries, Reuters reported. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.