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
Corporate Communications
ndhindsa@leafpharmaceuticals.com
Phone: +1 781 305 4192
References:
- 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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