CEL-SCI teams with Saudi Arabia pharmaceutical, healthcare company for Multikine

CEL-SCI (CVM) announced it has reached an agreement with one of Saudi Arabia’s pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine in the Kingdom of Saudia Arabia. The formal agreement is expected to be signed with the Saudi pharmaceutical partner which will file a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority in the coming weeks. According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of the Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia. Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and/or a potential joint venture to serve the wider Middle East and North Africa market. While CEL-SCI has the option of filing for Breakthrough Medicine Designation directly, the company made a strategic decision to collaborate with its local partner for the regulatory filing and subsequent commercial distribution in Saudi Arabia. In a prior meeting with the SFDA, the Saudi regulatory agency provided guidance and encouragement to seek breakthrough approval for Multikine in head and neck cancer. CEL-SCI and its Saudi pharma partner believe that Multikine meets all requirements for Breakthrough Medicine Designation as published by the SFDA and are now developing a comprehensive commercialization plan. This plan leverages the partner’s deep expertise in the local healthcare market to rapidly take Multikine through regulatory approvals and into distribution.