CEL-SCI’s Multikine Head and Neck Cancer Immunotherapy Breakthrough Medicine Designation Filed in Saudi Arabia: Allows for Patient Access and Reimbursement/Sale Upon Granting of the Designation Which Takes Approximately 60 Days Based on SFDA Timeline
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Memorandum of Understanding (MOU) signed with a leading Saudi Arabian pharma company which submitted the Breakthrough Medicine Designation to the
Saudi Food and Drug Authority (SFDA) -
Increasing interest in
from Saudi investment funds as Multikine advances through regulatory and drug distribution channelsCEL-SCI
Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.
According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in
The Saudi pharma company is well positioned to procure reimbursement and to accelerate Multikine’s sale and commercial launch.
Several leading Saudi funds have expressed interest in investing in Multikine,
“This MOU and the filing for Breakthrough Medicine Designation mark a significant advancement for Multikine’s global regulatory, patient access/sale and commercial roll out,” stated
About the SFDA’s Breakthrough Medicine Program
The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines’ benefits justify their risks.
Eligibility includes having to fulfill all of the following four criteria in order to gain a Breakthrough Medicine Designation:
- Target serious debilitating or life-threatening conditions with unmet medical need.
- The medicinal product is likely to offer major advantages over methods currently used.
- The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance.
- The product is not registered at any regulatory authority at the time of submission of the designation request.
About
Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
The Company has operations in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to finalize a partnering agreement and the risk factors set forth from time to time in
* Multikine (Leukocyte Interleukin, Injection) is the trademark that
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