#USA #Piramal Pharma #Sellersville #NewAmsterdam Pharma

Piramal Pharma Solutions and NewAmsterdam Pharma Boost Production Capacity

In a significant advancement for the pharmaceutical industry, Piramal Pharma Solutions and NewAmsterdam Pharma have jointly announced the establishment of a dedicated facility focused on enhancing the production capacities of oral solid dosage (OSD) forms at Piramal's Sellersville site in Pennsylvania. This multi-million dollar investment seeks to improve the efficiency and speed of delivering innovative treatments to patients in need.

On August 22, 2025, the two companies revealed that the new facility is aimed at meeting the expected high demand for NewAmsterdam’s fixed-dose combination (FDC) of obicetrapib/ezetimibe, a novel medication designed to combat high levels of LDL cholesterol. This collaboration marks an important step in addressing the growing needs for effective cholesterol-lowering therapies, which have proven to be inadequate in some cases.

A Strategic Facility Expansion

The dedicated OSD unit is part of Piramal Pharma Solutions' long-term strategy to optimize production across its facilities. The Sellersville site, known for its comprehensive range of pharmaceutical development and manufacturing services, has been enhanced through the modernization of existing equipment and the reorganization of spaces to create an exclusive area for producing FDC products. This strategic facility expansion will not only increase operational efficiency but also facilitate faster market access for NewAmsterdam's promising treatments.

The new state-of-the-art facility is designed for the turnkey production of multi-layer tablets, featuring advanced capabilities and technologies in granulation, compression, tablet manufacturing, and coating. This infrastructure will allow NewAmsterdam Pharma to expedite the production of its experimental FDC and ensure precision and efficiency that aligns with market demands.

Commitment to Patients and the Community

Peter DeYoung, CEO of Piramal Global Pharma, expressed excitement about the expanded production capabilities, stating, "This new manufacturing unit will not only improve our production capacity but will also reaffirm our commitment to patients.” He emphasized the urgency of developing effective therapies to assist patients who are at risk for cardiovascular diseases due to high cholesterol levels.

Douglas Kling, COO of NewAmsterdam Pharma, echoed this sentiment, stating, "By investing in the facilities at Sellersville, we are enabling the manufacturing of FDC with exceptional precision and efficiency to meet future commercial demands.” He also noted the significant collaboration benefits of working alongside a trusted partner.

Economic Impact

Beyond improving pharmaceutical production, this investment is expected to create over 20 jobs at the Sellersville site over the next five years, significantly contributing to the local economy and workforce. The establishment of this facility underscores a shared commitment between Piramal Pharma Solutions and NewAmsterdam Pharma for continuous improvement and patient care.

Both companies recognize that while the Sellersville unit is crucial for our future production needs, the partnership extends beyond this site. Facilities in Ahmedabad, India, and Pithampur have played key roles in supporting the development and supply chain, showcasing a robust global collaboration structure.

About Obicetrapib

Obicetrapib is a low-dose CETP inhibitor that NewAmsterdam is developing to address the limitations of existing LDL-lowering treatments. In various clinical trials, including phase 2 studies such as ROSE2 and TULIP, NewAmsterdam has demonstrated statistically significant reductions in LDL levels, paired with a safety profile comparable to placebo. The company is currently assessing obicetrapib in phase 3 trials aimed at evaluating its potential to lower major adverse cardiovascular events.

NewAmsterdam Pharma focuses on improving treatment options for metabolic diseases through innovative drug development, particularly in areas where existing therapies fall short. They aim to provide patients with effective, well-tolerated, and convenient cholesterol-lowering medications, meeting critical unmet needs in cardiovascular disease management.

Conclusion

The partnership and investment in the Sellersville site illustrate a significant stride toward enhancing drug production capacity while providing life-saving treatments to patients globally. As both Piramal Pharma Solutions and NewAmsterdam Pharma continue to grow in unison, they reaffirm their commitment to delivering quality and innovation within the pharmaceutical landscape, ensuring better health outcomes for patients around the world.