According to a statement released, the US-based CMO, which has state-of-the-art manufacturing facilities, previously underwent successful inspections by the United States Food and Drug Administration (FDA)
With deep experience in clinical and commercial manufacturing of drugs approved for marketing globally, the CMO will be responsible for both the clinical and large-scale commercial production of LEAF-1404 under conditions that are compliant with cGMP.
LEAF Rwanda plans to market LEAF-1404 in Africa and Europe.
It will use this opportunity to train, in the US, drug manufacturers from Rwanda and across Africa, in preparation for launching its cGMP compliant drug manufacturing plant, scheduled to be built in Kigali, Rwanda.
LEAF-1404 is a complex generic version of Caelyx®/Doxil®, a pegylated liposomal doxorubicin that has been available for over 20 years in the Western World for the treatment of ovarian cancer, breast cancer and Kaposi Sarcoma.
There is currently no generic version of Caelyx®/Doxil® approved in Europe or Africa. Global cancer statistics indicate that 90% of Kaposi Sarcoma cases in the world occur in Africa. Yet, with such a high disease burden, Caelyx®/Doxil® has not been accessible to patients in Africa.
According to Dr. Clet Niyikiza, the Founder, President, and CEO of L.E.A.F. Pharmaceuticals the manufacturing of LEAF-1404 under cGMP will take the company to a step closer to bringing innovative, safe and affordable anti-cancer drug to patients with breast cancer, ovarian cancer and Kaposi Sarcoma.
“In particular, LEAF-1404 will address a key gap in the treatment of patients with Kaposi Sarcoma in Africa who have had very limited or no access to this medicine for more than 20 years now. While the disease is still taking lives in Africa, it has been virtually eliminated in Western countries" he said.
The World Health Organization (WHO) reports that 1 of every 10 medicines found in Africa is substandard or falsified. These poor-quality products result in 100,000 deaths annually in Africa according to the British Broadcasting Corporation (BBC) news service.
Commenting on the development, Dr. Victor Moyo, Executive Vice President, Head of Research and Development and Chief Medical Officer of L.E.A.F. Pharmaceuticals said: "The high death rate from substandard or falsified medicines is simply not acceptable. LEAF Rwanda is taking this initiative to help supply high quality medicines to help treat cancer on the African continent."
The agreement, now in place, ensures end‐to‐end, fully integrated services for formulation and fill-finish of drug products under cGMP standards.
Dr Diane Gashumba, Rwanda’s Minister of Health noted in a statement that manufacturing LEAF-1404 under cGMP by LEAF Rwanda and making it available from Rwanda for the African continent and beyond, will enable access to an important and safe medicine to treat patients suffering from cancers of the breast, ovary and from Kaposi Sarcoma.
“ We look forward to a partnership with LEAF Rwanda and L.E.A.F. Pharmaceuticals to make this drug available readily, safely and affordably for the first time, as we strengthen our healthcare systems in Rwanda and across Africa", she said.
L.E.A.F. Rwanda is a wholly owned subsidiary of L.E.A.F. Pharmaceuticals that is focused on establishing Rwanda as a hub for biotechnology research and development (R&D) as well as pharmaceutical manufacturing and commercialization in Africa and beyond.