KIGALI, Rwanda and VALLEY FORGE, Pennsylvania, July 11, 2019 /PRNewswire/ -- L.E.A.F. Rwanda Ltd ("LEAF Rwanda") announced today that it has signed a manufacturing agreement with a US Contract Manufacturing Organization (CMO), through its United States (US) parent company, L.E.A.F. Pharmaceuticals LLC, to manufacture its first complex generic anticancer medicine, LEAF-1404, under global current good manufacturing practices (cGMP).
The US based CMO, which has state of the art sterile manufacturing facilities, has previously undergone successful inspections by United States Food and Drug Administration (US 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. LEAF Rwanda 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.
"The manufacturing of LEAF-1404 under cGMP will take us 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", says Founder, President, and CEO of L.E.A.F. Pharmaceuticals, Dr. Clet Niyikiza.
The World Health Organization (WHO) reports that 1 of every 10 medicines found in Africa is substandard or falsified (1). These poor-quality products result in 100,000 deaths annually in Africa according to the British Broadcasting Corporation (BBC) news service (2).
"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", says Dr. Victor Moyo, Executive Vice President, Head of Research and Development and Chief Medical Officer of L.E.A.F. Pharmaceuticals.
The agreement, now in place, ensures end-to-end, fully integrated services for formulation and fill-finish of drug products under cGMP standards.
"By manufacturing LEAF-1404 under cGMP by LEAF Rwanda and making it available from Rwanda for the African continent and beyond, we access 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", says Dr. Diane Gashumba, Minister of Health of the Republic of Rwanda.
For more information, please visit www.leafpharmaceuticals.com.
About L.E.A.F. Pharmaceuticals
L.E.A.F. Pharmaceuticals is a US global pharmaceutical company with a mission to discover, develop and commercialize innovative and safe therapies for cancer. The company is committed to Lifting and Empowering All Families (L.E.A.F.) by developing and making accessible new medicines for patients globally, especially the lesser served regions of the world.
About L.E.A.F. Rwanda
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. This Kigali, Rwanda headquartered company is working to attract and retain highly skilled biotechnology scientists and clinical researchers from Africa and elsewhere, in a quest to discover and develop innovative, high quality medicines against diseases that predominantly afflict the health of the African population. L.E.A.F. Rwanda has partnered with L.E.A.F. Pharmaceuticals to facilitate advanced skills transfer to the continent, for long term sustainability of a robust biotechnology industry in Africa.
Media Contact: Dr. Navreet Dhindsa
Phone: +1 781 305 4192
- WHO: https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products accessed on July 11, 2019
- BBC: https://www.bbc.com/news/av/business-47640706/solving-the-problem-of-fake-drugs-in-nigeria accessed on July 11, 2019
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