Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma, and NewAmsterdam Pharma Company have announced the opening of a dedicated oral solid dosage (OSD) form suite at Piramal’s facility in Sellersville, Pennsylvania, USA.
As one of Piramal Pharma Solutions’ focused drug product facilities, the Sellersville site provides comprehensive development and manufacturing services for various formulations, including several forms of OSDs. This addition will increase operational efficiency, helping NewAmsterdam Pharma to deliver its investigational drug therapy, if approved, to patients in need.
The suite represents a multi-million-dollar investment in equipment upgrades and enhancements to improve the site’s capabilities. This includes a reconfiguration of existing space to create a dedicated OSD suite that will be used exclusively for fixed-dose combination products. The new suite is designed for turnkey, multi-layer tablet production, equipped with advanced capabilities and technology to support granulation, compression, tableting, and coating.
This suite will facilitate the production of NewAmsterdam Pharma’s investigational FDC, a non-statin cholesterol medication to reduce LDL-C.
Although the suite is essential to the FDC’s production, the partnership between Piramal Pharma Solutions and NewAmsterdam Pharma extends beyond the Sellersville site. Piramal’s Ahmedabad PPDS, India site played a crucial role in the product’s development, while its Pithampur, India site provides dual sourcing support.
“We are thrilled to expand our OSD production capabilities at the Sellersville facility with this new manufacturing suite,” said Peter DeYoung, CEO, Piramal Global Pharma. “This addition will not only enhance our production capacity and speed, but reinforce our commitment to patient centricity, too.”
“By investing in Piramal Pharma Solutions’ Sellersville facility, we are enabling the manufacture of FDC with exceptional precision and efficiency to meet the future commercial demand,” said Douglas Kling, COO, NewAmsterdam Pharma. “We are excited to continue growing alongside our trusted partner, Piramal Pharma Solutions, and thrilled about the potential for our collaboration to benefit countless patients around the globe.”
Patients aren’t the only beneficiaries of this investment. Over the next five years, the suite is expected to create more than 20 new jobs at the Sellersville site, further contributing to the local economy and workforce.
This investment underscores the commitment to continuous improvement shared by Piramal Pharma Solutions and NewAmsterdam Pharma. By adding the new production suite, both companies can operate with greater efficiency and capacity, ultimately bringing the FDC product, if approved, to more patients in need.
What is Obicetrapib?
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, Rose2, Tulip, Rose, and Ocean, as well as the Company’s Phase 3 Brooklyn, Broadway and Tandem trials, evaluating obicetrapib as monotherapy or combination therapy, the company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of Mace.
The company completed enrollment of Prevail in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company.
