Rwanda to manufacture generic cancer drugs

Friday July 12 2019


Manufacturing the generic drug in Rwanda will make access and treatment for cancer patients better and more efficient in the region. PHOTO| FILE 

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A Kigali-based pharmaceutical company, L.E.A.F Rwanda plans to locally manufacture generic anticancer medicines, in a move that will ensure the availability and affordability of such drugs to patients in the country and across the region.

L.E.A.F Rwanda announced the development on Thursday after its American parent company – L.E.A.F Pharmaceuticals – signed a manufacturing agreement with an undisclosed company to begin clinical and large-scale commercial production of its LEAF-1404 drug.

Once the drug is approved by US drug authorities, it will first be marketed across Africa by L.E.A.F Rwanda in early 2020, after which a manufacturing plant will be established in Kigali.

In a statement, Rwanda’s Minister for Health, Diane Gashumba, said that manufacturing the generic drug in Rwanda will make access and treatment for cancer patients better and more efficient in the region.

“We look forward to a partnership with L.E.A.F Rwanda and L.E.A.F. Pharmaceuticals to make this drug available readily, safely and affordable for the first time, as we strengthen our healthcare systems in Rwanda and across Africa", Dr Gashumba said.

The L.E.A.F -1404 is a generic version of Caelyx®/Doxil®, which 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, yet statistics indicate that 90 percent of Kaposi Sarcoma cases in the world occur in Africa, according to the Global Cancer Observatory.

L.E.A.F Rwanda was established in 2017 as a subsidiary to improve biotechnology research and manufacture of pharmaceutics.

"The manufacturing of L.E.A.F-1404 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,” Founder and CEO of L.E.A.F Pharmaceuticals, Dr. Clet Niyikiza said in a statement.

“L.E.A.F-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.”

L.E.A.F Rwanda plans to market the cancer drug in Africa and Europe, as well as train its pharmacists in the US, in preparation for launching its international standards compliant drug manufacturing plant, in Kigali.

The World Health Organization reports that one of every 10 medicines found in Africa is substandard or falsified – resulting in 100,000 deaths annually.

Cancer is responsible for the deaths of about 5,000 people in Rwanda every year, accounting for 7 percent of deaths in the country, according to the World Health Organisation.

Last year, the disease killed 7662 people, the biggest killers including breast, cervix, prostate, liver and stomach cancers, according to the Global Cancer Observatory.

Over 10700 new cases were diagnosed in 2018 in Rwanda. In the region, Kenya has the highest cancer-related deaths — about 33,000 per year, data from WHO shows. Tanzania comes second with about 28,000 cancer deaths per year, followed by Uganda at about 21,000.