CETP inhibitor

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Piramal Pharma Solutions and NewAmsterdam Pharma Invest in Dedicated Suite to Enhance Oral Solid Dosage Production Capabilities at Piramal's Sellersville, Pennsylvania Site
Prnewswire· 2025-08-21 06:41
Core Insights - The investment represents a multi-million-dollar upgrade in equipment to enhance production capabilities for fixed dose combination (FDC) products [1][4] - The new manufacturing suite at the Sellersville facility will support the production of NewAmsterdam Pharma's investigational non-statin cholesterol medication aimed at reducing LDL-C [2][4] - The partnership between Piramal Pharma Solutions and NewAmsterdam Pharma is crucial for the development and production of the FDC, with significant contributions from Piramal's facilities in India [2][4] Company Developments - The new suite is expected to create over 20 new jobs at the Sellersville site over the next five years, contributing positively to the local economy [3] - The investment reflects a commitment to continuous improvement and operational efficiency, enabling both companies to meet future commercial demands for the FDC product [4] - NewAmsterdam Pharma is focused on developing obicetrapib, a low-dose CETP inhibitor, to address unmet needs in LDL-lowering therapies [5][6] Industry Context - NewAmsterdam Pharma operates in the late-stage clinical biopharmaceutical sector, targeting metabolic diseases with inadequate existing therapies [6] - Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) providing comprehensive services across the drug life cycle, enhancing its capabilities through this investment [7][8]
NewAmsterdam Pharma to Present Alzheimer's Biomarker Data from BROADWAY Trial at AAIC 2025
GlobeNewswire News Room· 2025-07-22 12:00
Core Insights - NewAmsterdam Pharma is set to present full data from the Alzheimer's Disease biomarker analyses in the BROADWAY clinical trial at the Alzheimer's Association International Conference on July 30, 2025 [1][2] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1][6] - The company aims to address unmet needs for safe and well-tolerated LDL-lowering therapies [6] Product Information - Obicetrapib is a novel, oral, low-dose CETP inhibitor being developed by NewAmsterdam to improve LDL-lowering treatment outcomes [5] - The company has observed statistically significant LDL-lowering effects in multiple Phase 2 trials, with a side effect profile similar to that of placebo [5] - NewAmsterdam commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, enrolling over 9,500 patients [5] Upcoming Events - The presentation titled "Effects of Obicetrapib, a Potent Oral CETP Inhibitor, on Alzheimer's Disease Biomarkers in 1727 Patients with Cardiovascular Disease" will take place on July 30, 2025, at 8:21 AM ET [2] - A live webcast and conference call will be hosted by NewAmsterdam at 10:00 AM ET on the same day to review the full AD biomarker data [2][3]