Septa Pharma Inc. Receives Health Canada Approval to Import Fludarabine Amid Tier 3 Shortage

Mississauga, ON – September, 2025 – Septa Pharma Inc. (“Septa”) is pleased to announce that Health Canada has granted approval to import Fludarabine, classified under Tier 3 drug shortage criteria, to address the current critical supply disruption in Canada. This approval allows Septa to distribute Fludarabine for urgent oncology use, including its essential role in CAR-T cell therapy protocols.

Tackling a Nationally Significant Shortage
Fludarabine is a cornerstone drug in hematologic cancer treatment, widely used in the conditioning (lymphodepletion) phase for patients undergoing CAR-T cell therapy, stem cell transplantation, and treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphomas. The ongoing global shortage, due to manufacturing and supply chain disruptions, has left many Canadian hospitals struggling to maintain continuity of care for critically ill patients.
CAR-T therapy, a groundbreaking form of immunotherapy where a patient’s own T-cells are engineered to attack cancer cells, relies on Fludarabine as part of the pre-treatment regimen. Without it, the efficacy and safety of CAR-T can be significantly compromised.

Health Canada’s Tier 3 Approval — What It Enables
This approval by Health Canada authorizes Septa Pharma to import Fludarabine for specific high-priority uses during the ongoing shortage, including:

• Pre-conditioning for CAR-T cell therapy, where Fludarabine is used in combination with cyclophosphamide to suppress the immune system and allow engineered T-cells to expand effectively.
• Stem cell transplantation, particularly in reduced-intensity regimens where alternatives may not be viable.
• Urgent treatment of hematologic malignancies when no acceptable therapeutic substitutes exist.

This temporary importation approval under Tier 3 classification represents an emergency access mechanism to mitigate patient harm during shortages.

Supporting CAR-T Programs Across Canada
As Canadian cancer centers increasingly adopt CAR-T therapy for both adult and pediatric populations, consistent access to Fludarabine has become mission-critical. The shortage has threatened delays or cancellations of life-saving CAR-T infusions — particularly concerning given the aggressive nature of relapsed/refractory blood cancers.

“CAR-T cell therapy is transforming cancer treatment, but it depends on reliable access to drugs like Fludarabine,” said President & CEO, Septa Pharma Inc.. “This approval by Health Canada, and Septa’s quick response, are essential steps in preserving treatment continuity.”

Septa’s approved Fludarabine supply will directly support active CAR-T programs and transplant centers across the country, in coordination with hospital networks and provincial cancer agencies.

Septa’s Commitment: Safe Access, Clinical Impact
Septa Pharma is mobilizing distribution channels immediately, prioritizing facilities administering CAR-T and transplantation therapies. Our supply and compliance framework includes:

• Collaborative Allocation – Working with hospital pharmacy leaders and oncology clinicians to ensure equitable distribution based on clinical urgency and institutional need.
• Strict Quality Controls – All imported Fludarabine will meet Health Canada standards for safety, storage, and transportation, including cold chain management as required.
• Transparent Communication – Septa will provide ongoing updates on availability, ordering, and guidance to optimize usage during the shortage period.

Looking Ahead: Stability Through Partnership
With domestic Fludarabine production timelines still uncertain, this importation solution offers an essential bridge for Canadian health systems. Septa continues to work closely with Health Canada and other stakeholders to support long-term supply resilience for oncology and critical care medications.

“This approval is not just about addressing a shortage – it’s about protecting access to cutting-edge therapies like CAR-T,” said Director, Drug Shortages at Septa Pharma Inc. “We are proud to support Canadian clinicians and patients in this crucial moment.”

About Septa Pharma Inc.
Septa Pharma Inc. is a Canadian pharmaceutical company focused on bridging critical drug shortages through regulatory agility, global sourcing, and healthcare collaboration. With prior Health Canada approvals for emergency drug importation, Septa is committed to ensuring continuity of care when the stakes are highest.

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