#United States #Lexington #Piramal Pharma #NP2 #Cyclophosphamide

Piramal Pharma Solutions and NP2 to Complete Cyclophosphamide Development

Piramal Pharma Solutions (PPS), a key player in the global Contract Development and Manufacturing Organization (CDMO) sector, along with NP2, a nonprofit manufacturer focused on generic drugs, announced that they are on the brink of completing the development phase for the generic cancer drug cyclophosphamide. This significant milestone is expected to finalize next month, in October.

The development and manufacturing processes are taking place at PPS's state-of-the-art sterile injectable facility located in Lexington, Kentucky. This collaboration is particularly significant as it addresses the persistent shortages of cyclophosphamide and related supply chain challenges, ensuring that patients across the United States maintain access to this essential medication.

Cyclophosphamide is a widely used oncology drug that plays a vital role in treating various forms of cancer, including breast cancer and retinoblastoma, a rare eye cancer found mostly in children. Given its importance, the shortage of cyclophosphamide has been a growing concern among healthcare providers and patients alike.

Telly Athanasopoulos, NP2's Head of Manufacturing, expressed enthusiasm about progressing to the manufacturing stage. He stated, "This next step is exciting as it aligns with NP2's mission of providing a consistent supply of the life-saving cyclophosphamide within the United States." He emphasized that the announcement is a positive development for both cancer patients and their oncology professionals who require a dependable source of this drug at stable prices.

In a recent survey by the National Comprehensive Cancer Network (NCCN) conducted with its affiliated institutions, alarming statistics revealed that all responding centers are faced with shortages of at least one anti-cancer drug, with over 20% reporting shortages of five or more medications. Among these, cyclophosphamide is one of the most critically affected.

The situation is exacerbated by the fact that the two primary manufacturers of cyclophosphamide are located overseas, controlling 92% of the U.S. market. One company accounts for nearly 70% of the ready-to-use 200 mg solution segment, based on Q2 IQVIA sales data. This dependency on foreign production underscores the urgency for domestic manufacturing solutions to mitigate the risks of shortages.

To combat this pressing issue, NP2 has initiated the development of cyclophosphamide at PPS’s Lexington facility, which is designed to streamline and shorten the supply chain, ultimately delivering the drug directly to the patients who need it most. Currently, the Lexington facility is undergoing an ambitious $85 million expansion to enhance the capacity to manufacture cyclophosphamide and other critical medications.

Peter DeYoung, CEO of Piramal Global Pharma, expressed pride in the partnership with NP2 and the efforts being taken to bolster the supply of vital oncology drugs for U.S. patients. He stated, "As we progress with the expansion of our Lexington site, we are creating a robust domestic supply chain to maintain reliable access to this essential cancer treatment."

The pressing shortage of cyclophosphamide not only affects patients but also raises significant concerns among medical professionals. Terri Miller, Executive Director of NP2, highlighted the gravity of the situation, noting that the current cycling of cyclophosphamide shortages across Europe and Canada is alarming. She reiterated NP2's commitment to manufacturing a consistent supply of this essential drug domestically, ensuring it is readily available for patients battling conditions such as lymphoma and leukemia.

Miller further pointed out, "The challenge we face in supplying cyclophosphamide is systemic rather than scientific. The concentration of cancer medicine manufacturing overseas creates unnecessary anxiety for cancer patients and their caregivers. A reliable U.S.-produced supply of cyclophosphamide—a cornerstone of cancer treatment—does not currently exist, but NP2 is on a mission to change that." She expressed a strong belief that patients should focus on their recovery rather than worrying about the availability of critical medications.

This collaborative effort marks a promising step toward establishing a secure and dependable supply of essential cancer medicines for U.S. patients, regardless of global geopolitical issues or supply chain disruptions.

About Piramal Pharma Solutions

Piramal Pharma Solutions is a recognized Contract Development and Manufacturing Organization (CDMO) providing comprehensive solutions across the drug lifecycle. With facilities in North America, Europe, and Asia, they offer a wide range of services, including drug discovery, process development, clinical trial supplies, and more.

About NP2

NP2 is a nonprofit dedicated to creating a sustainable and affordable supply of life-saving generic medicines, starting with key oncology drugs like cyclophosphamide, which is anticipated to be market-ready by mid-2028.