- Piramal Pharma Solutions (PPS) and nonprofit generic drug manufacturer NP2 plan to complete the drug development phase of generic cyclophosphamide in October.
- The sterile injectable oncology medicine is being developed at PPS’ Lexington, Kentucky site, which is undergoing an $85 million expansion to increase manufacturing capacity.
Piramal Pharma Solutions (PPS) and NP2 have announced plans to complete the drug development phase of generic cyclophosphamide in October. Cyclophosphamide is a generic sterile injectable oncology medicine used to treat several cancers, including breast cancer and retinoblastoma.
NP2 has been conducting cyclophosphamide drug development at PPS’ Lexington site, where the medicine will also be manufactured. The companies said this approach will shorten and simplify the supply chain between the manufacturing plant and cancer patients in the U.S. The Lexington site is currently undergoing an $85 million expansion to increase manufacturing capacity for drugs such as cyclophosphamide.
The companies said the development program is intended to address supply concerns around cyclophosphamide. The release cites shortages of the medicine in the EU and Canada and notes that the top two cyclophosphamide manufacturers, both overseas, account for 92% of U.S. sales, based on Q2 IQVIA sales data.
“Advancing to the manufacturing stage is an exciting next step in NP2’s mission to manufacture a steady supply of the life-saving cancer-fighting medicine cyclophosphamide right here in the United States.”
Telly Athanasopoulos, NP2’s Head of Manufacturing
The milestone moves the PPS-NP2 partnership toward manufacturing cyclophosphamide in the United States. PPS said the ongoing Lexington expansion is intended to build domestic manufacturing capacity and support access to the oncology medicine.
