What's Happening?
CEL-SCI Corporation has filed for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for its cancer immunotherapy, Multikine, in Saudi Arabia. The application was submitted by a leading Saudi pharmaceutical company, with which CEL-SCI has signed a Memorandum of Understanding for the commercialization of Multikine. The immunotherapy is designed to activate the immune system before surgery in patients with head and neck cancer, showing promising results in increasing survival rates in Phase 3 trials. The designation, expected to be granted within 60 days, would allow for immediate patient access and reimbursement in Saudi Arabia.
Why It's Important?
The filing for Breakthrough Medicine Designation in Saudi Arabia represents a strategic move for CEL-SCI to expand its market presence in the Middle East. Multikine's potential to improve survival rates for head and neck cancer patients aligns with Saudi Arabia's Vision 2030 and the National Biotechnology Strategy, emphasizing innovation in healthcare. Successful designation and subsequent commercialization could enhance CEL-SCI's financial performance and provide a new treatment option for patients, addressing unmet medical needs in the region.
What's Next?
CEL-SCI anticipates the SFDA's response to the designation application within 60 days. Upon approval, Multikine will be available for sale and reimbursement in Saudi Arabia, with plans for a final partnership agreement with the Saudi pharma company in the third quarter of 2025. CEL-SCI is also exploring investment opportunities with Saudi funds to further its commercialization efforts in the Middle East and North Africa.
