Multikine Saudi Arabia partnership marks a strategic agreement between CEL-SCI Corporation and Amarox for the registration, commercialization, and distribution of Multikine in Saudi Arabia. The companies signed a 50/50 revenue-sharing agreement for sales of the cancer immunotherapy in the kingdom upon receipt of the Saudi Food and Drug Authority’s Breakthrough Medicine Designation.
Under the agreement, Amarox will serve as the local regulatory representative and lead all communications with the Saudi Food and Drug Authority (SFDA). The company will seek the SFDA’s Breakthrough Medicine Designation, which would accelerate Multikine’s availability to patients in Saudi Arabia. Upon SFDA approval, Amarox will receive exclusive rights to distribute Multikine for head and neck cancer treatment in the kingdom, with an optional extension to Gulf Cooperation Council countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates.
CEL-SCI retains full ownership of all Multikine intellectual property, manufacturing know-how, and global rights. Amarox has ranked first in SFDA applications for critical and unavailable medicines for three consecutive years: 2022, 2023, and 2024.
Market Opportunity and Health Technology Growth
The immunotherapy segment represents one of the fastest-growing sectors in Saudi Arabia’s cancer market. According to market projections, the immunotherapy segment is expected to reach $2.7 billion by 2033. Head and neck cancer is the sixth most common cancer globally, with approximately 900,000 newly diagnosed cases per year. Stage 3 and 4 patients represent a significant unmet medical need.
About Multikine and Its Mechanism
Multikine is administered before surgery as a treatment for newly diagnosed, previously untreated head and neck cancer. The therapy is designed to activate a patient’s immune system to fight cancer before surgical, radiation, and chemotherapy treatments weaken immune function. The drug has been dosed in over 740 patients in clinical studies and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.
Strategic Alignment with Saudi Vision 2030
The SFDA’s Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs addressing unmet medical needs in treating serious or life-threatening conditions. The program aligns with Saudi Arabia’s Vision 2030 initiative. By pursuing the Breakthrough Medicine Designation, CEL-SCI and Amarox position Multikine Saudi Arabia as a high-priority national health initiative, potentially making Saudi Arabia the first region globally to commercialize this neoadjuvant immunotherapy.
Geert Kersten, Chief Executive Officer of CEL-SCI, stated that the partnership marks a significant milestone for the company’s commercial strategy in the region. He noted that Amarox’s track record with the SFDA, combined with its commercial infrastructure and oncology expertise, strengthens the ability to bring Multikine to patients in a region prioritizing rapid access to breakthrough cancer treatments.
Amarox’s Track Record in Saudi Pharma
Amarox operates as one of the fastest-growing pharmaceutical companies in Saudi Arabia, engaged in manufacturing, marketing, and supply of therapies. The company focuses on expanding its oncology portfolio while addressing unmet medical needs in Middle Eastern countries. Dr. Abdullah Alzomaie, Chief Executive Officer of Amarox, stated that Saudi Arabia is advancing its position as a regional hub for innovative healthcare and advanced therapies. He noted the company’s commitment to exploring the regulatory pathway for Multikine and evaluating its potential role in addressing unmet needs in oncology care across Saudi Arabia and the GCC region.
First Berlin, a corporate finance and investment firm based in Berlin, Germany, acted as CEL-SCI’s sole advisor in structuring and executing the strategic partnership with Amarox.
