• Piramal and NP2 are set to complete the drug development phase of the generic cancer drug cyclophosphamide this October.
• The development and manufacturing activities are being conducted at Piramal's dedicated sterile injectable facility in Lexington, Kentucky.
• This partnership addresses ongoing cyclophosphamide shortages and supply chain risks, safeguarding access to this critical medicine for patients across the U.S.

Piramal Pharma Solutions ("PPS"), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd. ("PPL") (NSE: PPLPHARMA) (BSE: 543635), and its partner NP2, a nonprofit generic drug manufacturer, announced their plans to finish the drug development phase of the generic cancer drug cyclophosphamide in October. 

"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," said Telly Athanasopoulos, NP2's Head of Manufacturing. "Today's announcement is good news for cancer patients and their doctors, who need a safe, reliable supply of cyclophosphamide at stable prices."

According to a National Comprehensive Cancer Network (NCCN) survey conducted in late August of NCCN member institutions, 100% of respondents are experiencing a shortage of at least one anti-cancer agent and more than 20% of centers are currently in a shortage for five or more cancer medications. One such medicine is cyclophosphamide, which is currently in short supply in the EU and Canada. The top two cyclophosphamide manufacturers, both overseas, account for 92% of U.S. sales, and one currently serves nearly 70% of the U.S. 200 mg ready-to-use solution market., according to Q2 IQVIA sales data.

To combat this issue, NP2 has been conducting cyclophosphamide drug development at PPS' Lexington site, where it will also manufacture cyclophosphamide, shortening and simplifying 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 like cyclophosphamide.

"We are proud to partner with NP2 on this important initiative to strengthen the supply of critical oncology medicines for patients in the United States," said Peter DeYoung, CEO of Piramal Global Pharma. "With the ongoing expansion of our Lexington facility, we are building a more resilient domestic supply chain and helping to support reliable access to this essential cancer therapy."

"What we're seeing with the cyclophosphamide shortages in the EU and Canada is clearly alarming," said Terri Miller, Executive Director of NP2. "NP2 is committed to manufacturing a steady supply of cyclophosphamide, a life-saving cancer-fighting medicine, in the United States so it's readily available to patients who need it to battle diseases like lymphoma and leukemia during one of the toughest times of their lives," said Terri Miller, NP2's Executive Director.

"The problem NP2 is committed to solve for patients isn't about the science, it's about the system," Miller added. "Consolidation of cancer medicines' manufacturing capacity overseas keeps cancer patients and their doctors up at night. A reliable U.S.-made supply of cyclophosphamide—a mainstay cancer-fighting medicine—does not exist today. NP2 is building it. We believe patients should be able to focus on fighting their cancer, not fretting about the availability of a life-saving drug they urgently need. That's what motivates us to move forward," Miller concluded.

This milestone in the PPS-NP2 partnership brings us closer to a future where patients in the U.S. have secure and reliable access to essential cancer medicines, regardless of geopolitical challenges or global supply chain disruptions.