Strong interest from Saudi investment funds in CEL-SCI, Multikine, and potential joint venture to address the wider Middle East and North Africa market

CEL-SCI Corporation  announced it has reached an agreement with one of Saudi Arabia’s premier pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine* (Leukocyte Interleukin, Injection) 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 (SFDA) 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 (MENA) market.

Health Technology Insights: Lustgarten Foundation Appoints Arthur Kuan, MS, to Board of Directors

We are seeing a significant level of interest in Multikine and CEL-SCI amongst Saudi investment and healthcare leaders. What CEL-SCI offers is exactly in line with Saudi Arabia’s Vision 2030 initiative which seeks to make the Kingdom a global biotech hub.

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.

“We have been directly, and through our representative, First Berlin of Germany and its local Saudi representatives, engaging with medical, regulatory and financial experts in Saudi Arabia in preparation for the regulatory filing to the SFDA. These meetings and the support of leaders in the pharmaceutical industry, healthcare and other sectors in Saudi Arabia, are critical ingredients to bringing our cancer drug to market in the Kingdom. Several meetings have also occurred with some of the most important Saudi Arabian funds that have expressed interest in investing in CEL-SCI directly or the venture between CEL-SCI and our Saudi pharma partner,” stated CEL-SCI CEO, Geert Kersten.

Health Technology Insights: ACA Pharma Secures Fast-track Approval For Eagle Pharmaceuticals’ Ryanodex In Macau

Martin Bailey, Managing Director and Founder of First Berlin, commented, “We are seeing a significant level of interest in Multikine and CEL-SCI amongst Saudi investment and healthcare leaders. What CEL-SCI offers is exactly in line with Saudi Arabia’s Vision 2030 initiative which seeks to make the Kingdom a global biotech hub. Given the SFDA’s short timeline, this is a near term opportunity for local in-country investors to help bring a much-needed cancer treatment to market while also supporting their nation’s health-tech goals.”

Multikine is an immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. In the world’s largest head and neck cancer study spanning 20 countries, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone. The 5-year risk of death was halved from 55% to 27%.

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 include 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 advantage 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.

Health Technology Insights: Rhode Island Creates Rare Disease Advisory Council

To participate in our interviews, please write to our HealthTech Media Room at sudipto@intentamplify.com

Source – businesswire