Piramal Pharma and NewAmsterdam Pharma Enhance Production Capacity in Pennsylvania
Piramal Pharma Solutions, a worldwide leader in contract development and manufacturing, in collaboration with NewAmsterdam Pharma, has announced the opening of a specialized production area dedicated to oral solid dosage (OSD) forms at the Piramal facility located in Sellersville, Pennsylvania. The investment, amounting to several million dollars, aims to bolster commercial manufacturing capabilities for NewAmsterdam’s fixed-dose combination (FDC) of Obicetrapib and Ezetimib. This initiative is designed to meet the anticipated high commercial demand for these formulations.
The Sellersville site, one of Piramal Pharma Solutions' specialized manufacturing facilities, is well-equipped to provide comprehensive development services for various pharmaceutical formulations, particularly focusing on OSD forms. The establishment of this dedicated area is expected to enhance operational efficiency significantly and facilitate the delivery of novel therapies under development by NewAmsterdam Pharma, once they receive regulatory approvals.
Peter DeYoung, CEO of Piramal Global Pharma, expressed enthusiasm about expanding OSD production capabilities. He stated, "This expansion will not only increase our production capacity and speed but also reinforce our commitment to patient-centric approaches in drug manufacturing." Douglas Kling, COO of NewAmsterdam Pharma, echoed this sentiment, highlighting the ability to produce FDCs with exceptional precision and efficiency, thereby ensuring that the needs of patients are adequately met.
To support these advancements, the dedicated OSD suite has undergone a complete redesign, geared specifically towards the production of fixed-dose combination products. Equipped with cutting-edge features and technologies, this facility will focus on the complete production process, including granulation, tableting, and coating. This versatile facility is integral to NewAmsterdam's FDC testing program, which targets LDL-C reduction without the use of statins, representing a significant innovation in cholesterol treatment.
Furthermore, this collaboration extends beyond the Sellersville location. Piramal's site in Ahmedabad, India, has been instrumental in the development of the product while their second facility in Pithampur, India, provides supporting procurement operations. The facility not only serves as a pivotal hub for research and development but also represents a substantial boost to the local economy, with expectations of creating over 20 new jobs over the next five years, thus positively impacting the community surrounding the Sellersville site.
As both companies commit to continuous improvement, this investment underscores a strategic partnership that prioritizes efficiency and capacity to ensure a timely response to market demands. NewAmsterdam's Obicetrapib has emerged as a pivotal product in addressing unmet needs for safe, well-tolerated, and convenient LDL-lowering therapies. Through various Phase 2 and Phase 3 clinical studies, the drug has shown significant reductions in LDL cholesterol levels with an adverse event profile comparable to that of a placebo.
Obicetrapib operates as a novel CETP inhibitor, part of NewAmsterdam's effort to overcome the limitations of current LDL-lowering therapies. The company is currently running multiple clinical trials, including the PREVAIL study, which began in March 2022 and focuses on cardiovascular outcomes associated with the treatment. With recruitment completed by April 2024, the study includes a substantial patient cohort to evaluate the efficacy of Obicetrapib.
In summary, the new production facility at the Piramal site in Sellersville marks an important milestone in pharmaceutical manufacturing, aligning with the growing demand for innovative therapies while simultaneously delivering on the commitment to patient care and enhancing job opportunities in the region. Through strategic partnerships and robust manufacturing capabilities, both Piramal Pharma Solutions and NewAmsterdam Pharma are well-positioned to make significant strides in the healthcare landscape, addressing critical patient needs effectively and efficiently.
The Sellersville site, one of Piramal Pharma Solutions' specialized manufacturing facilities, is well-equipped to provide comprehensive development services for various pharmaceutical formulations, particularly focusing on OSD forms. The establishment of this dedicated area is expected to enhance operational efficiency significantly and facilitate the delivery of novel therapies under development by NewAmsterdam Pharma, once they receive regulatory approvals.
Peter DeYoung, CEO of Piramal Global Pharma, expressed enthusiasm about expanding OSD production capabilities. He stated, "This expansion will not only increase our production capacity and speed but also reinforce our commitment to patient-centric approaches in drug manufacturing." Douglas Kling, COO of NewAmsterdam Pharma, echoed this sentiment, highlighting the ability to produce FDCs with exceptional precision and efficiency, thereby ensuring that the needs of patients are adequately met.
To support these advancements, the dedicated OSD suite has undergone a complete redesign, geared specifically towards the production of fixed-dose combination products. Equipped with cutting-edge features and technologies, this facility will focus on the complete production process, including granulation, tableting, and coating. This versatile facility is integral to NewAmsterdam's FDC testing program, which targets LDL-C reduction without the use of statins, representing a significant innovation in cholesterol treatment.
Furthermore, this collaboration extends beyond the Sellersville location. Piramal's site in Ahmedabad, India, has been instrumental in the development of the product while their second facility in Pithampur, India, provides supporting procurement operations. The facility not only serves as a pivotal hub for research and development but also represents a substantial boost to the local economy, with expectations of creating over 20 new jobs over the next five years, thus positively impacting the community surrounding the Sellersville site.
As both companies commit to continuous improvement, this investment underscores a strategic partnership that prioritizes efficiency and capacity to ensure a timely response to market demands. NewAmsterdam's Obicetrapib has emerged as a pivotal product in addressing unmet needs for safe, well-tolerated, and convenient LDL-lowering therapies. Through various Phase 2 and Phase 3 clinical studies, the drug has shown significant reductions in LDL cholesterol levels with an adverse event profile comparable to that of a placebo.
Obicetrapib operates as a novel CETP inhibitor, part of NewAmsterdam's effort to overcome the limitations of current LDL-lowering therapies. The company is currently running multiple clinical trials, including the PREVAIL study, which began in March 2022 and focuses on cardiovascular outcomes associated with the treatment. With recruitment completed by April 2024, the study includes a substantial patient cohort to evaluate the efficacy of Obicetrapib.
In summary, the new production facility at the Piramal site in Sellersville marks an important milestone in pharmaceutical manufacturing, aligning with the growing demand for innovative therapies while simultaneously delivering on the commitment to patient care and enhancing job opportunities in the region. Through strategic partnerships and robust manufacturing capabilities, both Piramal Pharma Solutions and NewAmsterdam Pharma are well-positioned to make significant strides in the healthcare landscape, addressing critical patient needs effectively and efficiently.
Topics Health）
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