Piramal Pharma Solutions and NewAmsterdam Pharma Invest in Dedicated Suite to Enhance Oral Solid Dosage Production Capabilities at Piramal's Sellersville, Pennsylvania Site
The multi-million-dollar investment provides NewAmsterdam Pharma with commercial capacity for fixed dose combination (FDC) of obicetrapib and ezetimibe to meet potentially high commercial demand.
Piramal Pharma Solutions harnessed the strength of two additional facilities to efficiently produce the FDC, demonstrating the advantages of its integrated approach to development.
MUMBAI, India, Aug. 21, 2025 /PRNewswire/ -- Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPHARMA) (BSE: 543635), and NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) today 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.
(L-R) Stu Needleman, Chief Commercial Officer and Chief Patient Centricity Officer, Piramal Pharma Solutions; Douglas Kling, Chief Operating Officer, NewAmsterdam Pharma; Sheng Cui, Chief Manufacturing Officer, NewAmsterdam Pharma; Mahesh Kulkarni, Ph.D., Senior Director, Drug Product, NewAmsterdam Pharma; Manoj Zalpuri, North American Operations Head, Piramal Pharma Solutions; Ian Smart, Managing Partner, Verta Life Sciences; and Daniel Kloss, Sellersville Site Head, Piramal Pharma Solutions, unveil the dedicated OSD suite at the Sellersville facility.
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.
About 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.
About NewAmsterdam
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage clinical biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. The Company seeks to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
About Piramal Pharma Solutions
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines and gene therapies, made possible through Piramal Pharma Limited's associate company, Yapan Bio Private Limited.
Piramal Pharma Limited (PPL, NSE: PPLPHARMA I BSE: 543635), offers a portfolio of differentiated products and services through its 17* global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated contract development and manufacturing organization; Piramal Critical Care (PCC), a complex hospital generics business; and the Piramal Consumer Healthcare business, selling over-the-counter consumer and wellness products. In addition, one of PPL's associate companies, Abbvie Therapeutics India Private Limited, a joint venture between Abbvie and PPL, has emerged as one of the market leaders in the ophthalmology therapy area in the Indian pharma market. Further, PPL has a strategic minority investment in Yapan Bio Private Limited, that operates in the biologics / bio-therapeutics and vaccine segments.
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