L.E.A.F. Pharmaceuticals LLC and its Affiliate L.E.A.F Rwanda Ltd Enter into an Agreement with a Contract Manufacturing Organization

VALLEY FORGE, Pennsylvania - Jul 12, 2019 (PRN):

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.



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