Piramal Pharma Solutions, a global leader in contract development and manufacturing (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPHARMA) (BSE: 543635), and NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) announced the opening of a dedicated oral solid dosage form (OSD) area at the Piramal facility in Sellersville, Pennsylvania, USA. As one of Piramal Pharma Solutions' pharmaceutical manufacturing plants, the Sellersville site provides comprehensive development and manufacturing services for various formulations, including various forms of OSDs. This increase will increase operational efficiencies and help NewAmsterdam Pharma deliver its investigational drug therapies, if approved, to patients who need them.

The area represents a multi-million dollar investment in upgrading and improving equipment to improve the site's capabilities. This includes redesigning the existing space to create a dedicated OSD suite that is used exclusively for fixed combination products. The new plant has been designed for the ready-to-use production of multilayer tablets and is equipped with advanced features and technologies to support granulation, pressing, tableting and coating.

This facility will facilitate the production of NewAmsterdam Pharma's investigational FDC, a statin-free cholesterol drug designed to lower LDL-C.

Although the facility is essential to the production of the FDC, the partnership between Piramal Pharma Solutions and NewAmsterdam Pharma extends beyond the Sellersville site. Piramal's PPDS site in Ahmedabad, India, played a crucial role in the development of the product, while the site in Pithampur, India supports dual procurement.

"We are very pleased to expand our OSD manufacturing capabilities at the Sellersville site with this new manufacturing facility," said Peter DeYoung, Managing Director of Piramal Global Pharma. "This expansion will not only increase our production capacity and speed, but also increase our commitment to patient centricity."

"By investing in Piramal Pharma Solutions' facility in Sellersville, we are enabling the production of FDC with exceptional precision and efficiency to meet future commercial demand," said Douglas Kling, Chief Operating Officer of NewAmsterdam Pharma. "We are excited to continue to grow together with our trusted partner, Piramal Pharma Solutions, and are excited about the potential of our collaboration, which will benefit countless patients around the world."

Patients are not the only beneficiaries of this investment. Over the next five years, the facility is expected to create more than 20 new jobs at the Sellersville site, further contributing to the local economy and workforce.

This investment underlines the joint commitment of Piramal Pharma Solutions and NewAmsterdam Pharma to continuous improvement. The new manufacturing facility will allow both companies to operate with greater efficiency and capacity, so that the FDC product, if approved, will be available to more patients who need it.

Information about Obicetrapib

Obicetrapib is a novel low-dose CETP inhibitor in oral dosage form that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In all of the Company's Phase 2 studies, ROSE2, TULIP, ROSE and OCEAN, as well as in the Phase 3 BROOKLYN, BROADWAY and TANDEM studies evaluating obicetrapib as a monotherapy or combination therapy, the Company observed a statistically significant reduction in LDL in combination with a side effect profile similar to placebo. In March 2022, the company began the Phase 3 PREVAIL cardiovascular outcomes study, which was designed to evaluate the potential of obicetrapib to reduce MACE events. The company completed recruitment for PREVAIL in April 2024 and randomized over 9500 patients. The marketing rights for obicetrapib in Europe, either as a monotherapy or as part of a fixed combination with ezetimibe, have been granted exclusively to the Menarini Group, an Italian-based, leading international pharmaceutical and diagnostics company.