CEL-SCI Corporation (NYSE American: CVM) signed a strategic partnership agreement with Amarox for the registration, commercialization and distribution of Multikine in Saudi Arabia, with optional expansion to Gulf Cooperation Council countries.

Under the agreement, the companies will share net revenue from Multikine sales in Saudi Arabia on a 50-50 basis upon receipt of Breakthrough Medicine Designation from the Saudi Food and Drug Authority. Amarox will serve as the local regulatory representative and lead communications with Saudi regulators.

Amarox will receive exclusive distribution rights for Multikine in Saudi Arabia upon SFDA approval. CEL-SCI retains ownership of all Multikine intellectual property, manufacturing know-how and global rights. The agreement includes potential expansion to other GCC countries including Bahrain, Kuwait, Oman, Qatar and the United Arab Emirates.

Multikine is a cancer immunotherapy administered before surgery as treatment for newly diagnosed head and neck cancer. The therapy has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.

Amarox ranks as the top company for SFDA applications for critical and unavailable medicine for three consecutive years from 2022 to 2024. The Saudi pharmaceutical company focuses on regulatory excellence, oncology and specialty pharmaceuticals across Saudi Arabia and the GCC region.

The partnership targets the SFDA Breakthrough Medicine Program, which aims to accelerate development and review of new drugs addressing unmet medical needs for serious conditions. This aligns with Saudi Arabia's Vision 2030 initiative for healthcare advancement.

Head and neck cancer represents the sixth most common cancer globally, with approximately 900,000 newly diagnosed cases annually. The immunotherapy market in Saudi Arabia is projected to reach $2.7 billion by 2033, according to the press release.