#USA #Lexington #Piramal Pharma #NP2 #Cyclophosphamide

Piramal Pharma Solutions and NP2 Finalize Cyclophosphamide Development Phase

Piramal Pharma Solutions (PPS) and NP2 have announced that they will conclude the development phase of cyclophosphamide, a critical generic cancer treatment, in October. This achievement comes in response to the persistent shortages of cyclophosphamide, which is vital for patients in the United States battling various forms of cancer, including breast cancer and retinoblastoma, a type affecting young children.

The collaboration aims to ensure a consistent supply of cyclophosphamide by conducting both development and manufacturing activities at PPS's dedicated sterile injectable facility located in Lexington, Kentucky. This initiative is particularly important as it seeks to mitigate supply chain risks and maintain stable access to this essential medication for patients in need.

Peter DeYoung, CEO of Piramal Global Pharma, stated, "We are proud to partner with NP2 on this significant initiative that enhances the supply of essential oncology medications for patients in the U.S. By expanding our Lexington site, we are establishing a more resilient national supply chain while ensuring reliable access to this essential cancer treatment."

Terri Miller, Executive Director of NP2, emphasized the urgency of this partnership in light of alarming cyclophosphamide shortages reported in both the European Union and Canada. She mentioned, "NP2 is committed to ensuring a steady supply of vital cancer drugs, like cyclophosphamide, so they are easily accessible to patients facing challenges such as lymphoma and leukemia."

According to a survey by the National Comprehensive Cancer Network (NCCN) conducted in late August, every participating member facility reported facing a shortage of at least one cancer treatment agent. More than 20% of these centers are challenged by a shortage of five or more cancer drugs. Currently, cyclophosphamide is among these critical medications that are difficult to obtain. The two major manufacturers of cyclophosphamide, both located overseas, account for 92% of U.S. market sales, with one holding nearly 70% of the market for ready-to-use 200 mg solutions.

In an effort to remedy these shortages, NP2 is conducting cyclophosphamide development at the PPS facility in Lexington, where they will also handle the drug’s manufacturing. This localization of production is designed to streamline the supply chain and improve reliability, ultimately facilitating better access to cyclophosphamide for cancer patients in the U.S.

The Lexington facility is currently undergoing an $85 million expansion project aimed at increasing production capacity for drugs like cyclophosphamide. This expansion not only symbolizes growth for Piramal Pharma Solutions but also represents a significant step towards ensuring a sustainable supply of cancer treatments amid global disruptions.

Piramal’s focus on enhancing its capabilities aligns with NP2’s mission of addressing the systemic issues in the supply chain that affect cancer patients. "The focus of NP2 is not just on science but on the underlying systems that deliver care to patients," Miller explained. "Our goal is to establish a reliable supply of cyclophosphamide—a critical medication in cancer treatment that is currently unavailable from U.S. sources. By establishing this supply, we aim to alleviate the anxiety among patients and their families regarding the availability of essential medications during one of the toughest times in their lives."

As they move toward completing this developmental phase, PPS and NP2’s partnership signifies a promising future where U.S. patients can count on safe and reliable access to essential cancer medications, regardless of geopolitical challenges or global supply chain disruptions. This collaborative effort is poised to significantly impact patient care and the broader healthcare landscape in the United States, ensuring that life-saving treatments remain accessible to those who need them most.

About Piramal Pharma Solutions

Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) that offers end-to-end development and manufacturing services throughout the drug lifecycle. With an integrated global network of facilities across North America, Europe, and Asia, the organization provides a full range of services including drug discovery solutions, pharmaceutical development processes, clinical trial supplies, and commercial delivery of active pharmaceutical ingredients and finished dosage forms.

The organization also specializes in highly potent active pharmaceutical ingredients and antibody-drug conjugates, along with other critical healthcare solutions.

About NP2

NP2 is a non-profit generic drug manufacturer focused on creating a more reliable, affordable, and resilient supply of critical medications, starting with essential oncology drugs. Their flagship product, an injectable form of cyclophosphamide, is under development for production in Lexington, Kentucky, and is expected to become available by mid-2028.