LEAF Rwanda has announced it has signed a deal that paves way for the manufacturing of its first complex generic cancer medicine, LEAF-1404, under global current Good Manufacturing Practices (cGMP).
The agreement was reached with US Contract Manufacturing Organisation (CMO), through the firm’s parent company, LEAF Pharmaceuticals LLC, which is based in the United States.
According to a statement, 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).
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 its cGMP compliant drug manufacturing plant, to be built in Kigali.
LEAF-1404 is a complex generic version of Caelyx/Doxil, another chemotherapy drug 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 per cent 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.
Dr Clet Niyikiza, the Founder and Chief Executive Officer of LEAF Pharmaceuticals, said the manufacturing of LEAF-1404 will take them a step closer to bringing an 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,” he noted.
Dr Clet Niyikiza, the founder and chief executive officer of LEAF Pharmaceuticals. / Net photo
Kaposi Sarcoma is a type of cancer that causes lesions in the soft tissues. While the disease claims many lives in Africa, it has been virtually eliminated in Western countries, Niyikiza says.
The World Health Organization reports that 1 out of every 10 medicines in Africa is substandard or falsified. These poor-quality products result in significant deaths annually in Africa.
Dr Victor Moyo, Executive Vice President, Head of Research and Development and Chief Medical Officer of LEAF Pharmaceuticals, insists that 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,” he says.
The agreement entered between the two parties generally 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,” Dr Diane Gashumba, the Minister for Health, noted in a statement.
She added that the partnership will make the drug available readily, safely and affordable for the first time, as “we strengthen our healthcare systems in Rwanda and across Africa.”
Cancer drugs are currently hardly accessible to many ordinary Africans. This is because they are expensive. But as the continent push for large scale commercial production of the drugs, they will eventually be easily accessible.
Dr Niyikiza told The New Times that they are approaching various countries and their regulatory units across Africa to negotiate the exact pricing of the drug to make it accessible.
The drug could hit the Rwandan market as early as mid-next year.