Lilly targets India as global export hub amid booming Mounjaro sales, executive says | ReutersSkip to main content[Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv]Visitors stand at the kiosk of Eli Lilly at the BioAsia conference in Hyderabad, India, February 17, 2026. Picture taken with a mobile phone. REUTERS/Sriparna Roy [Purchase Licensing Rights, opens new tab]- Companies- Summary- Also plans to bring other products to India, such as Alzheimer's drug donan ...

Core Viewpoint - Tiziana Life Sciences has initiated a Phase 2 clinical trial for intranasal foralumab, targeting early Alzheimer's disease, marking a significant step in exploring immunomodulatory therapies for neuroinflammation [1][3][7]. Group 1: Clinical Trial Details - The Phase 2 trial is randomized and placebo-controlled, assessing the safety, tolerability, and potential efficacy of intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab or donanemab [4]. - Primary endpoints of the trial include neuroinflammation measured by TSPO-PET imaging, cognitive function, and changes in amyloid and tau biomarkers, with interim data expected in 2026 [4]. Group 2: Scientific Rationale - TSPO-PET imaging data indicates persistent microglial activation in Alzheimer's patients, even after treatment with anti-amyloid therapies, highlighting the need for therapies that address residual neuroinflammation [2]. - Intranasal foralumab is designed to modulate immune responses and reduce activated microglia, potentially slowing disease progression in early Alzheimer's disease [2][3]. Group 3: Company Insights - Gabriele Cerrone, Chairman & Founder, emphasized the importance of this trial in exploring a novel approach to Alzheimer's treatment, building on previous data showing foralumab's ability to reduce microglial activation in multiple sclerosis patients [3]. - Ivor Elrifi, CEO, expressed enthusiasm for the rapid progress from enrollment to first patient dosing, reflecting the urgent need for new treatment strategies beyond amyloid clearance [3]. Group 4: About Foralumab - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, with previous studies showing positive outcomes in patients with non-active secondary progressive multiple sclerosis [5][6]. - It is the only fully human anti-CD3 monoclonal antibody currently in clinical development, representing a novel treatment avenue for neuroinflammatory and neurodegenerative diseases [6]. Group 5: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, aiming to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [6][8].

Core Viewpoint - Tiziana Life Sciences has initiated enrollment for a Phase 2 clinical trial of intranasal foralumab, targeting early Alzheimer's disease, with the first patient expected to be dosed next week [1][10]. Group 1: Clinical Trial Details - The Phase 2 trial will assess intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab or donanemab, in early Alzheimer's patients [2][9]. - Baseline assessments including cognitive testing and TSPO-PET imaging have been completed for initial participants [2][11]. - Key endpoints of the trial will include measures of neuroinflammation, cognitive function, and changes in biomarkers related to amyloid and tau pathology [11]. Group 2: Scientific Insights - New TSPO-PET imaging evidence shows persistent microglial activation in an Alzheimer's patient treated with lecanemab, indicating ongoing neuroinflammation despite amyloid plaque reduction [3][4]. - Dr. Howard Weiner emphasized that clearing amyloid does not eliminate the brain's inflammatory response, suggesting that intranasal foralumab may effectively address this residual neuroinflammation [6][10]. Group 3: Mechanism of Action - Intranasal foralumab is designed to induce regulatory T cells to migrate to the brain, potentially calming activated microglia and reducing neuroinflammation [6][10]. - The therapy aims to provide an additive or synergistic benefit when used alongside anti-amyloid treatments by targeting both amyloid pathology and persistent microglial inflammation [9][10]. Group 4: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, with intranasal foralumab being the only fully human anti-CD3 monoclonal antibody in clinical development [13]. - The company aims to improve efficacy, safety, and tolerability of treatments compared to traditional intravenous delivery methods [13].

Prothena Corporation FY Conference Summary Company Overview - **Company**: Prothena Corporation (NasdaqGS:PRTA) - **Focus**: Expertise in protein dysregulation with a robust pipeline in neurodegenerative diseases, including Alzheimer's, Parkinson's, and ATTR cardiomyopathy [2][22] Key Programs and Developments - **Phase 3 Programs**: - **Prasunezumab**: Targeting early Parkinson's disease in collaboration with Roche, expected to initiate in Q4 2025 [2][22] - **Coramitug**: Targeting ATTR cardiomyopathy in collaboration with Novo, which has already initiated Phase 3 [2][22] - **Phase 2 Program**: - **PRX019**: Targeting tau in Alzheimer's disease, partnered with Bristol Myers Squibb [2][22] - **Phase 1 Program**: - **PRX012**: An undisclosed target for neurodegeneration, also partnered with Bristol [2][22] Financial Outlook - Prothena anticipates earning up to **$105 million** in clinical milestones in 2026 related to coramitug and PRX019 [2][22] Shareholder Actions - Recently approved a share repurchase program for 2026 to support distributable reserves [2][22] Pipeline Insights - **Alzheimer's Program**: The company is exploring partnerships to advance its amyloid beta program, emphasizing the importance of collaboration for cost efficiency and bandwidth [4][5] - **Transferrin Technology**: Prothena is developing PRX012, which incorporates transferrin technology to enhance blood-brain barrier penetration. Preclinical data is expected in 2026 [7][17][18] Clinical Data and Efficacy - **Amyloid Reduction**: Over **80%** of patients treated with the amyloid beta molecule are reported to be amyloid negative after 18 months [5][6] - **ARIA Rates**: Reported around **40%** for the amyloid beta treatment, with ongoing efforts to mitigate these effects [6][7] - **Coramitug Data**: Recent presentations showed a **50%** difference from placebo in NT-proBNP levels, supporting the move to Phase 3 [24][25] Collaborations and Partnerships - Prothena has established strong collaborations with Roche, Novo, and Bristol Myers Squibb, focusing on scientific dialogue and clinical decision-making [22][26] - The company is actively supporting partner programs as they transition into Phase 3 [26] Regulatory Considerations - The company is preparing for potential IND submissions, with ongoing discussions with the FDA regarding preclinical toxicology requirements [8][9] Market Position and Future Directions - Prothena is positioning itself to leverage its unique constructs in the competitive landscape of Alzheimer's treatments, particularly with its transferrin-based technology [17][40] - The company is closely monitoring developments in the field, including Eli Lilly's studies, to inform its strategic direction [5][40] Conclusion - Prothena Corporation is advancing multiple promising programs in neurodegenerative diseases, with a strong focus on collaboration and innovative technologies to enhance treatment efficacy and patient outcomes [2][22][40]

Core Insights - Eli Lilly and Company (India) has received approval from the Central Drugs Standard Control Organization (CDSCO) for donanemab, a drug aimed at treating Alzheimer's disease in adults with early symptomatic stages [1][2] - The approval is seen as a significant milestone in addressing the urgent needs of individuals living with Alzheimer's disease in India [2] - Donanemab is designed to target amyloid plaques and slow cognitive decline, potentially improving the quality of life for patients and their families [3] Industry Context - Alzheimer's disease is the most common cause of dementia globally, accounting for 60-70% of dementia cases [3] - The disease remains highly underdiagnosed in India, with projections indicating that over 8 million people will be living with dementia in the country by 2030, with Alzheimer's representing the largest share of these cases [4]

Core Insights - Eli Lilly and Company is recognized as one of the best healthcare stocks to buy and hold for five years due to its strong market position and innovative product portfolio [2] Group 1: Company Overview - Eli Lilly is a global biopharmaceutical leader with a focus on diabetes, obesity, oncology, immunology, and neurology [2] - The company has a portfolio that includes blockbuster drugs such as Mounjaro and Zepbound for diabetes and obesity, and donanemab for Alzheimer's disease [2] Group 2: Expansion Plans - In September 2025, Eli Lilly announced plans for a $6.5 billion manufacturing facility in Houston, Texas, aimed at expanding production for small-molecule medicines, including orforglipron [3] - The new facility is expected to create several hundred jobs and will be operational within five years, reinforcing the company's commitment to next-generation obesity treatments [3] Group 3: International Growth - Eli Lilly is pursuing international growth with plans to launch orforglipron in India, pending regulatory approval, to capture demand for oral weight-loss drugs in emerging markets [4] - The company has streamlined its pipeline by halting the development of a muscle-preserving drug paired with Zepbound to focus on its most promising obesity assets [4] Group 4: Regulatory Approvals and Financial Performance - Eli Lilly strengthened its neurology portfolio as European regulators granted marketing authorization for donanemab, enhancing its position in Alzheimer's disease therapies [5] - The firm reported strong international growth for Mounjaro, although U.S. sales faced slight challenges due to isolated formulary issues, yet global demand for tirzepatide-based treatments remains robust [5]