Daily Archives: July 12, 2019

L.E.A.F. Pharmaceuticals LLC et sa filiale L.E.A.F. Rwanda Ltd concluent un accord avec un façonnier pour la fabrication du LEAF-1404

KIGALI, Rwanda et VALLEY FORGE, Pennsylvanie, 12 juillet 2019 /PRNewswire/ — L.E.A.F. Rwanda Ltd (« LEAF Rwanda ») a annoncé ce jour la signature d’un contrat avec un façonnier américain, par l’intermédiaire de sa société mère américaine, L.E.A.F. Pharmaceuticals LLC, pour la fabrication de son premier anticancéreux générique complexe, le LEAF-1404, selon les normes CGMP mondiales.

L.E.A.F. Pharmaceuticals

Installé aux États-Unis, le façonnier, qui dispose d’installations de fabrication stériles de pointe, a été inspecté avec succès par la FDA (United States Food and Drug Administration). Fort d’une longue expérience dans la fabrication clinique et commerciale de médicaments approuvés pour le marché international, le façonnier sera chargé de la production clinique et à grande échelle du LEAF-1404 dans des conditions conformes aux normes CGMP. LEAF Rwanda envisage de commercialiser le LEAF-1404 en Afrique et en Europe. À cette occasion, la filiale formera aux États-Unis des fabricants de médicaments du Rwanda et d’autres pays d’Afrique, en vue de la construction à Kigali de son usine aux normes CGMP.

LEAF-1404 est une version générique complexe du Caelyx®/Doxil®, doxorubicine liposomale pégylée disponible depuis plus de 20 ans en Occident et servant au traitement du cancer ovarien, du cancer du sein et du Sarcome de Kaposi. Il n’existe actuellement aucune version générique du Caelyx®/Doxil® approuvée en Europe ou en Afrique. Les statistiques internationales sur le cancer indiquent que 90 % des cas de Sarcome de Kaposi dans le monde sont recensés en Afrique. Pourtant, malgré le fardeau considérable de la maladie, les patients de ce continent n’ont pas accès au Caelyx®/Doxil®.

« Grâce à la fabrication du LEAF-1404 selon les normes CGMP, nous allons nous rapprocher de notre objectif de fournir un anticancéreux innovant, sûr et abordable aux patients atteints du cancer du sein, du cancer ovarien et du Sarcome de Kaposi. LEAF-1404 viendra combler un vide considérable dans le traitement des patients africains souffrant du Sarcome de Kaposi, qui depuis plus de 20 ans n’ont pas ou peu eu accès à ce médicament. Alors que la maladie fait toujours des victimes en Afrique, elle a pratiquement été éradiquée dans les pays occidentaux », déclare le Dr. Clet Niyikiza, fondateur, président et PDG de L.E.A.F. Pharmaceuticals.

L’Organisation mondiale de la santé (OMS) rapporte qu’un médicament sur dix en Afrique est de qualité inférieure ou contrefait (1). La médiocrité de ces produits y a entraîné 100 000 décès selon l’agence de presse de la BBC (British Broadcasting Corporation) (2).

« Le fort taux de mortalité dû aux médicaments médiocres ou contrefaits est inacceptable. En prenant cette initiative, LEAF Rwanda pourra fournir des médicaments de qualité au continent africain », déclare le Dr. Victor Moyo, directeur général adjoint, responsable de la recherche et du développement, et directeur du service médical de L.E.A.F. Pharmaceuticals.

Le contrat en place assure l’intégration complète des services pour la formulation et le remplissage-finition de produits médicamenteux aux normes CGMP.

« La fabrication du LEAF-1404 selon les normes CGMP par LEAF Rwanda pour le mettre à la disposition du continent africain depuis le Rwanda donnera aux patients atteints du cancer du sein, des ovaires et du Sarcome de Kaposi accès à un médicament important et sûr. Nous avons hâte de collaborer avec LEAF Rwanda et L.E.A.F. Pharmaceuticals afin d’offrir dans les meilleurs délais ce médicament à la fois sûr et abordable, alors que le Rwanda et les autres pays africains renforcent leur système de soins », déclare Dr. Diane Gashumba, ministre de la Santé de la République du Rwanda.

Pour en savoir plus, rendez-vous sur le site www.leafpharmaceuticals.com.

À propos de L.E.A.F. Pharmaceuticals

L.E.A.F. Pharmaceuticals est une société pharmaceutique internationale américaine dont la mission est de découvrir, de mettre au point et de commercialiser des thérapies innovantes et sûres contre le cancer. La société s’engage à soutenir et à autonomiser toutes les familles (Lifting and Empowering All Families, L.E.A.F.) en développant et en rendant accessibles de nouveaux médicaments pour les patients du monde entier, notamment ceux des régions les plus défavorisées.

À propos de L.E.A.F. Rwanda

L.E.A.F. Rwanda est une filiale à 100 % de L.E.A.F. Pharmaceuticals, dont la mission est de faire du Rwanda la plaque tournante de la recherche et du développement (R&D) en biotechnologie, et de la fabrication et de la commercialisation de produits pharmaceutiques en Afrique et au-delà. Basée à Kigali, cette société s’efforce d’attirer et de retenir des scientifiques et des chercheurs cliniques, d’Afrique ou d’ailleurs, hautement spécialisés en biotechnologie dans le but de découvrir et de mettre au point des médicaments innovants et de qualité contre les maladies affectant principalement la population du continent. L.E.A.F. Rwanda travaillera en partenariat avec L.E.A.F. Pharmaceuticals LLC pour faciliter le transfert de compétences avancées vers le continent africain et développer à long terme un secteur de biotechnologie robuste en Afrique.

Contact médias : Dr. Navreet Dhindsa
Communications d’entreprise
ndhindsa@leafpharmaceuticals.com
Téléphone : +1 781 305 4192

Références :

  1. OMS : https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products consulté le 11 juillet 2019
  2. BBC : https://www.bbc.com/news/av/business-47640706/solving-the-problem-of-fake-drugs-in-nigeria consulté le 11 juillet 2019

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L.E.A.F. Pharmaceuticals LLC and its Affiliate L.E.A.F. Rwanda Ltd Enter into an Agreement with a Contract Manufacturing Organization to Manufacture LEAF-1404

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).

L.E.A.F. Pharmaceuticals

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. PharmaceuticalsDr. 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:

  1. WHO: https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products accessed on July 11, 2019
  2. 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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South Sudan President Agrees to Meet Former Rebel Leader

JUBA – South Sudanese opposition leader Riek Machar has agreed to a face-to-face meeting with President Salva Kiir, a step that could energize the lagging talks on a government for the civil war-wracked country.

In a letter dated July 8 and sent to President Kiir’s security adviser, Tut Gatluak, Machar said he is ready to talk with the president as long as he can freely move about in South Sudan.

The Kiir administration invited Machar to meet with Kiir after the government and opposition groups missed a May deadline to form a transitional government of national unity. The period was extended for another six months.

In the letter viewed by VOA, Machar said he will meet Kiir to discuss the challenges of implementing pre-transition activities since recent months have passed without substantial progress.

Norway Ambassador to South Sudan Lars Anderson said two months of the six-month extension of the pretransitional period have already come and gone with little to show.

He said the parties to last year’s peace deal must implement security arrangements immediately in order to pave the way for the formation of a unity government on time.

There shouldn’t be more extensions. That is clear from the agreement they have, according to themselves. Now it’s fairly predictable by November there will be another form of political crisis around that. And it is really going to be up to the parties how they manage this, Anderson told VOA’s South Sudan in Focus.

Representatives of the various parties who sit on the National Pre-Transitional Committee have held several meetings on implementing the peace deal. Anderson said the international community wants Kiir and Machar to meet regularly to build trust and confidence among their supporters and to show they are working together to achieve peace.

I think at this point it’s not about people on the ground working together because we have also seen good working cooperation between the military with the different armed groups. So it is not about people on the ground, it is about top leadership now coming together and showing their strong commitment to this,” Anderson said.

In May, shortly after the parties agreed to extend the pretransitional period, the Kiir administration pledged $100 million to fund pretransitional activities including security arrangements. It’s not clear if the government has released the money it pledged.

Machar urged Kiir to make a special request to the Transitional Military Council in Khartoum, where he said he’s being held under house arrest. He wants Sudanese authorities to transport him to Juba and back to Khartoum after the talks.

Stephen Par Kuol, SPLM-IO secretary for foreign relations, said Machar should be able to go wherever he wants once Machar arrives in South Sudan.

We had been demanding as a party that our chairman should be set free to participate physically in peace dissemination in this process of peace implementation, Kuol told South Sudan in Focus.

Paar said the two leaders will talk about how to quickly implement critical security arrangements that are behind schedule.

CTSAMM, the body monitoring the implementation of the security arrangements, warned last week that by dragging out the pretransitional activities, the parties risk failing to establish the unity government in November. CTSAMM Chairman Desta Abiche confirmed the parties have yet to assemble and integrate their forces, a key component of the security arrangements.

Source: Voice of America

Sudan on High Alert After Military Says it Foiled Coup Attempt

KHARTOUM – Sudanese troops were deployed in the streets of Khartoum following the Transitional Military Council’s announcement Thursday that it had stopped a coup attempt by military officers.

“After an accurate monitoring, the security forces have arrested [a] number of senior and junior officers who plotted for this failed coup attempt,” the head of the TMC’s security and defense committee, Lieutenant General Jamal Omar, said on state television. “Their number is 12 and now they are under arrest and we will hunt down the others who were involved in the failed attempt, including the head of the coup attempt.”

Omar said the alleged coup attempt was aimed at halting the power-sharing agreement between the TMC and the opposition Forces for Freedom and Change.

A leading member of the FFC, Faisal Babikir, said the coup attempt was led by soldiers still allied with ousted president Omar al-Bashir, who the military overthrew in April after months of mass anti-government protests.

“I believe that these are serious attempts to foil the power sharing deal we agreed upon as TMC and FFC, so I also believe that this attempt may not be the last one,” Babikir said.

The TMC and FFC have said they are putting the last technical touches on the power-sharing deal.

African Union mediators have said the sides will sign the final agreement very soon.

Source: Voice of America