#USA #Piramal Pharma #NewAmsterdam #Sellersville

Piramal Pharma Solutions Expands Production Capacity at Sellersville Facility

Piramal Pharma Solutions, a frontrunner in the Contract Development and Manufacturing Organization (CDMO) landscape, in collaboration with NewAmsterdam Pharma Company, has recently inaugurated a specialized suite dedicated to oral solid dosage (OSD) production at its Sellersville, Pennsylvania site. This significant multi-million-dollar investment marks a strategic advancement in Piramal’s capabilities to meet the rising demand for fixed dose combination (FDC) products, particularly the novel cholesterol medication combining obicetrapib and ezetimibe.

Strategic Importance of the New Suite

The new suite represents more than just physical space; it symbolizes a concerted effort to enhance operational efficiency and production quality. Equipped with state-of-the-art technology, the facility offers advanced features for granulation, compression, tableting, and coating. This investment not only bolsters Piramal’s production capacity but also aligns with the company's commitment to delivering high-quality pharmaceutical solutions. The collaboration between Piramal and NewAmsterdam aims to expedite the delivery of investigational therapies to patients in need, potentially revolutionizing treatment paradigms in metabolic diseases.

Peter DeYoung, CEO of Piramal Global Pharma, expressed excitement about the expansion, noting that it reinforces their dedication to patient-centric development. “This addition will enhance our production capacity and speed, facilitating timely delivery of essential therapies,” he stated. Moreover, Douglas Kling, COO of NewAmsterdam Pharma, highlighted the importance of this venture in addressing significant unmet patient needs, particularly in effectively lowering LDL cholesterol levels without the adverse effects common in traditional treatments.

Broader Impact on the Community

Beyond the immediate benefits for pharmaceutical production, the suite is poised to create over 20 new jobs within the Sellersville community over the next five years. This job creation is anticipated to positively impact the local economy, contributing to workforce development and stability. Piramal and NewAmsterdam are high on creating jobs in the regions they operate, demonstrating a commitment not just to their businesses, but also to the communities that support them.

Comprehensive Development Strategy

The project is a manifestation of Piramal's integrated approach to drug development and manufacturing, illustrated by the collaboration across different geographical sites. While the Sellersville facility is now home to the dedicated OSD suite, the initial development of the investigational drug therapy took place at Piramal's Ahmedabad site in India, with additional support from their facility in Pithampur. Such a collaborative model showcases the strength of Piramal Pharma Solutions’ global footprint and its ability to leverage resources effectively.

Obicetrapib, the compound at the center of these advancements, is set to undergo rigorous testing as part of NewAmsterdam’s ongoing clinical trials. The Phase 3 PREVAIL trial, which commenced in early 2022, aims to validate the efficacy and safety of obicetrapib in reducing major adverse cardiovascular events (MACE), thus exemplifying the commitment to better patient outcomes.

Conclusion

The establishment of this dedicated OSD suite at Piramal's Pennsylvania site is a pivotal move in enhancing production capabilities for NewAmsterdam Pharma, promising to streamline the manufacturing process. As the pharmaceutical landscape rapidly evolves with increasing demands for innovative therapies, partnerships like these underscore the importance of collaboration in bringing forth cutting-edge solutions to improve patient lives globally.

Piramal Pharma Solutions continues to reaffirm its position as a key player in the pharmaceutical manufacturing sector while ensuring community development and patient accessibility remain at the forefront of its operational missions.