Piramal Pharma Solutions and nonprofit generic drug manufacturer NP2 expect to complete the development phase of their injectable cyclophosphamide product in October. Development is taking place at Piramal’s sterile injectable facility in Lexington, Kentucky, where the partners also plan to manufacture the drug.
Cyclophosphamide is a generic medicine used to treat several cancers, including breast cancer and retinoblastoma. NP2’s project is intended to establish a U.S. manufacturing source for the drug amid concerns about supply concentration and shortages in other markets.
The companies cited second-quarter IQVIA sales data showing that two overseas manufacturers account for 92% of U.S. cyclophosphamide sales. One of those manufacturers serves nearly 70% of the U.S. market for the 200-milligram ready-to-use solution, according to the data cited in the release.
Piramal’s Lexington site is undergoing an $85 million expansion to increase sterile injectable manufacturing capacity. The companies plan to keep both development and production of the NP2 cyclophosphamide product at that facility.
Telly Athanasopoulos, NP2’s head of manufacturing, said completing development would allow the project to advance toward manufacturing. Piramal Global Pharma CEO Peter DeYoung said the Lexington expansion will support production of oncology medicines in the United States.
The announcement also cited an August survey of National Comprehensive Cancer Network member institutions in which every respondent reported a shortage of at least one anticancer drug. More than 20% reported shortages of five or more cancer medicines.
NP2 Executive Director Terri Miller said the organization’s goal is to establish a consistent domestic supply of cyclophosphamide for U.S. patients.