Mumbai, if (OTS/Prnewswire)
- The investment of several million dollars provides Newamsterdam Pharma Commercial capacity for the fixed combination (FDC) from Obicentrapib and Ezetimib in order to cover the potentially high commercial demand.
- Piramal Pharma Solutions used the strength of two additional systems for the efficient production of FDC and thus demonstrated the advantages of his integrated development approach.
Piramal Pharma Solutions, a worldwide leading company for order development and production (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPharma) (BSE: 543635), as well as Newamsterdam Pharma Company NV (Nasdaq: Nams) today announced the opening of a special area for fixed oral dosage forms (OSD) in the Piramal facility in Sellersville, Pennsylvania, USA. As one of the works of Piramal Pharma Solutions that concentrate on the production of pharmaceuticals, the Sellersville location offers extensive development and manufacturing services for various formulations, including various forms of OSDS. This increase will increase operational efficiency and Newamsterdam Pharma will help to deliver its drug therapies in testing, if they are approved, to patients who need.
The area stands for an investment of several million dollars in the upgrade and improvement of the equipment to improve the location of the location. This also includes the redesign of the existing space to create its own OSD suite that is used exclusively for fixed combination products. The new system was constructed for the ready -to -use production of multi -layer tablets and equipped with advanced functions and technologies to support granulation, pressing, tablets and coating.
This system will facilitate the production of the FDC test preparation of Newamsterdam Pharma, a cholesterol medication without statins to reduce the LDL-C.
Although the system is essential for the production of the FDC, the partnership between Piramal Pharma Solutions and Newamsterdam Pharma goes beyond the Sellersville location. Piramals PPDS location in Ahmedabad, India, played a crucial role in the development of the product, while the location in Pithampur, India, supported double procurement.
“We are very pleased to expand our OSD production capacities at the Sellersville location with this new production facility,” said Peter Deyoung, Managing Director of Piramal Global Pharma. “This expansion will not only increase our production capacity and speed, but will also increase our use for patient centering.”
“By investing in the system of Piramal Pharma Solutions in Sellersville, we enable the production of FDC with exceptional precision and efficiency to cover future commercial demand,” said Douglas Kling, operations manager of Newamsterdam Pharma. “We are pleased to continue growing together with our reliable partner Piramal Pharma Solutions, and are enthusiastic about the potential of our cooperation, which benefits countless patients around the world.”
The 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 location and thus make another contribution to the local economy and workers.
This investment underlines the joint commitment of Piramal Pharma Solutions and Newamsterdam Pharma for continuous improvements. Thanks to the new production system, both companies can work with greater efficiency and capacity, so that the FDC product, if it is approved, is available.
Information about Obicentrapib
Obicetrapib is a new CETP inhibitor in a low dosage in oral dosage form that Newamsterdam develops in order to overcome the restrictions on the current LDL-reducing treatments. In all phase 2 studies of the company, Rose2, Tulip, Rose and Ocean, as well as Brooklyn, Broadway and Tandem in the phase 3 studies, in which Obicetrapib was examined as a mono or combination therapy, the company observed statistically significant LDL reduction in combination with a side effect profile that resembles the placebo. In March 2022, the company began with the Phase 3 study on cardiovascular results that was developed to evaluate the potential of Obicentrapib to reduce MACE events. The company completed the recruitment for Prevail in April 2024 and randomized over 9,500 patients. The marketing rights for Obicentrapib in Europe, either as a monotherapy or as part of a fixed combination with ezetimib, were exclusively awarded to the Menarini Group, a pharmaceutical and diagnostic company based in Italy.
Information on Newamsterdam
Newamsterdam Pharma (NASDAQ: NAMS) is a biopharmaceutical company in the late clinical development phase that has set itself the goal of improving patients with metabolic diseases for which currently approved therapies are not suitable or not well tolerated. The company tries to cover the considerable uncovered need for safe, well tolerated and comfortable LDL-lowering therapy. In several phase-3 studies, Newamsterdam Obicetrapib, an oral, low-dosed and once daily CETP inhibitor, alone or as a fixed combination with ezetimib, as an LDL-C-reducing therapy in patients with increased LDL-C and cardiovascular risk, is not sufficient for the existing therapies or are well tolerated.
Information on Piramal Pharma Solutions
Piramal Pharma Solutions (PPS) is an order development and manufacturing company (Contract Development and Manufacturing Organization, CDMO), which offers end-to-end development and manufacturing solutions for the entire life cycle of medicinal products. We serve our customers through a globally integrated network of locations in North America, Europe and Asia. This enables us to offer a comprehensive range of services, including solutions for drug research, process and pharmaceutical development services, accessories for clinical studies, commercial delivery of API and finished dosage forms. We also offer specialized services such as the development and manufacture of highly effective APIs, antibody-active ingredient conjugates, sterile bottling/completion, peptide products and services as well as effective solid oral medicines. PPS also offers development and manufacturing services for biologicals, including vaccines, genetic therapies and monoclonal antibodies, which were made possible by investing Piramal Pharma Limited in Yapan Bio Private Limited.
Further information is available on: Piramal Pharma Solutions | LinkedIn| Facebook | X
Information on Piramal Pharma Limited
Piramal Pharma Limited (PPL, NSE: PPLPharma I BSE: 543635) offers a portfolio of differentiated products and services via its 17* worldwide development and production facilities and a global sales network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated order development and manufacturing company, Piramal Critical Care (PCC), a division for complex hospital generics, and Piramal Consumer Healthcare that sells over-the-counter consumer and wellness products. In addition, one of PPLS partner company, Abbvie Therapeutics India Private Limited, has established a joint venture between Abbvie and PPL, as one of the market leaders in the field of ophthalmology on the Indian pharmaceutical market. Furthermore, PPL holds a strategic minority stake in Yapan Bio Private Limited, a company that works in the areas of biologics/biotherapeutics and vaccines.
You can find more information on: Piramal pharma | LinkedIn
*Comprises a system via the minority stake from PPL to Yapan Bio.
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