US-based biotechnology company CEL-SCI has teamed up with a Saudi Arabian pharmaceutical firm to advance Multikine (leukocyte interleukin, injection) for head and neck cancer in Saudi Arabia.
CEL-SCI’s new Saudi partner will begin regulatory and commercial activities, including filing a Breakthrough Medicine Designation application with the Saudi Food and Drug Authority (SFDA) in the coming weeks.
SFDA would respond to the Breakthrough Medicine Designation application within 60 days.
Once approved, Multikine will be available for patient access and reimbursement in Saudi Arabia.
Several Saudi investment funds have shown interest in investing in Multikine, CEL-SCI, or a joint venture for the wider Middle East and North Africa market.
CEL-SCI opted to collaborate with its local partner for the regulatory filing and distribution in Saudi Arabia, despite having the option to file directly.
The partnership aims to leverage the local partner’s expertise to expedite Multikine’s regulatory approval and distribution.
CEL-SCI CEO Geert Kersten said: 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.”
Multikine, an immunotherapy administered before surgery, is used for newly diagnosed, previously untreated head and neck cancer.
In a global study across 20 countries, Multikine increased the five-year survival rate to 73% compared to 45% with standard care and reduced the five-year risk of death from 55% to 27%.
The SFDA’s Breakthrough Medicine Programme is designed to expedite the development and review of new drugs that meet unmet medical needs for serious conditions.
The regulatory agency had previously encouraged CEL-SCI to seek breakthrough approval for Multikine in head and neck cancer.
First Berlin founder and managing director Martin Bailey said: “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.”
