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Novartis launches new anti-malarial formulation, reaffirms commitment to quality healthcare for Africa

Novartis has announced today the launch of a new high quality antimalarial formulation of Coartem® 80/480 (artemether/lumefantrine 80 mg/480 mg), for the treatment of uncomplicated malaria in adults and older children who weigh above 35kg. The drug has been registered by the Pharmacy and poisons board in Kenya, has already been launched in Nigeria and Angola. Kenya is the 3rd country in Africa to launch Coartem 80/480. Other countries that have registered Coartem 80/480 include Uganda and Ghana.

In a bid to enhance patient compliance, the full course of treatment for malaria has been reduced from 24 tablets to six tablets translating into a 75% reduction in pill burden.

On this day, Novartis joins the people of Kenya and the rest of Africa, in celebrating a great achievement in the fight against malaria. According to Dr. Nathan Mulure, the Novartis Medical Manager for Africa, Malaria is highly preventable and curable, yet it is still one of the most deadly diseases in developing countries. “Novartis reaffirms its strong commitment to the fight against malaria. This achievement is a truly remarkable milestone contributing to treating many patients and help in the reduction of disease burden. The fewer tablets offer a convenient solution for busy lives. “The launch of Coartem® 80/480 in Kenya marks another milestone in the fight against Malaria, and will benefit patients with a convenient and high quality treatment for malaria,” he said. The Coartem 80/480 was first registered in Switzerland by a stringent health authority, the Swiss Medic.

Novartis pioneered the launch of a fixed-dose ACT, and ten years later, in 2009, the first dispersible ACT was tailored to meet the needs of children who are the most vulnerable to malaria. “Through a partnership with the World Health Organization (WHO) in 2001, we were the first company in the healthcare industry to commit to the supply of antimalarial treatments to the public sector in endemic countries without profit”, added Dr Nathan Mulure. Since 2006, Kenya has received over 75 million treatments of Coartem. Kenya is thus one of the largest recipients of Coartem.

Each year there are more than one million malaria-related deaths around the world. Nine out of ten malaria deaths occur in sub Saharan Africa, and the vast majority of malaria-related deaths occur in children. In Africa alone, a child dies every 60 seconds from malaria.

As part of its ongoing commitment to patients and health workers, Novartis also provides malaria case management educational programs, which include hands-on training for local healthcare workers, customized training manuals, and user-friendly packaging to ensure that Coartem and Coartem Dispersible are properly used and to improve patient compliance.

Kenya

Novartis and Kenya have a longstanding relationship. Today, Novartis runs a range of innovative programs in the areas of oncology, transplantation, malaria, patient access in rural areas and local capacity building in R&D, with the aim of becoming the leading healthcare company in the country.

In oncology, Novartis has established a global patient access program, working locally with Nairobi Hospital in order to treat chronic myeloid leukemia (CML). In the Glivec International Patients Assistance Program (GIPAP), Novartis fully subsidizes the costs of cancer medication for 450 Kenyan CML patients in need.

In order to respond to a largely unmet medical need in the area of renal transplantation, Novartis partners with the Kenyatta National Hospital and expert surgeons in Spain to build a center of excellence for renal transplantation in Kenya as well as across East Africa. Through the Interlife program, the capacity for renal transplant has clearly improved and over 110 patients have undergone a renal transplant. There is now an increased demand for locally performed renal transplant in Kenya.

Novartis has contributed to lowering the burden of malaria in Kenya. The country is one of the largest recipients of our antimalarial Coartem®. We have delivered over 75 million Coartem® treatments without profit to the public sector in Kenya since 2006. From 2010, we have been participating in the expansion of access to quality-assured ACTs in the private sector through the Affordable Medicines Facility for Malaria (AMFm), and since 2012, through our own private-sector access program also known as the NPP project.

To increase access to medicine in rural areas, Novartis has launched Familia Nawiri (Swahili for healthy families), a program focusing on providing essential medicines at affordable prices. In 2013, the program was scaled up to reach 20 locations in 10 counties in the Central, Western, Nyanza and South Rift parts of Kenya, covering a population of 700,000 people.

Finally, Novartis also works with the Kenya Research Medical Institute to build capacity for clinical trials, training, R&D in Kenya. Projects include a clinical trial and a Phase 1 workshop, a mathematical mo7deling program and an annual grant for Kenyan scientists to join research internship programs in Basel and Cambridge designed to train the “Next Generation of Scientists in Africa”.

 

Novartis Milestones In The Fight Against Malaria

In 2001, Novartis signed a memorandum of understanding with the World Health Organization to provide at no profit, Coartem to malaria endemic countries all over the world. Since then, Coartem has grown from 100,000 treatments per year product to over 100 million treatments, a milestone that was achieved in the year 2011.

Novartis is the first company to develop a WHO prequalified child friendly medication, the Coartem Dispersible. Dispersible tablets easily break up in water, are sweet and easy to take. Two sites in Kenya participated in the phase 3 clinical trials of Coartem Dispersible tablet. Since 2009, over 200 million dispersible tablets have been delivered the vast majority to African countries. Coartem dispersible was jointly developed by Novartis and MMV, Medicines for Malaria Venture, whose mission is to “reduce the burden of malaria in disease-endemic countries by discovering, developing and facilitating delivery of new, effective and affordable antimalarial drugs”.

Together with Swiss Tropical Institute and the Novartis Foundation, research in the ALIVE project continues to progress well, benefiting many inhabitants of the East Africa region. This project has increased access to high quality medicine and registered remarkable success in the recent past.

Coartem is the only FDA approved ACT in the United States of America and the first one to be approved by the European Medical Evaluating Agency, EMEA. This is testimony to the fact that the drug is of high quality and meets stringent regulatory requirements. Coartem continues to show high efficacy in clinical and operational research.

Novartis seeks to expand efforts to improve access to healthcare in Africa and the launch of the new antimalarial drug aims to re-iterate its commitment to Kenya and the region. In addition to existing corporate responsibility programs such as the Novartis Malaria Initiative, Novartis will seek to significantly increase its presence in Kenya in 2014.

In a unique collaboration with international organizations, Novartis has provided more than 600 million Coartem treatment courses to the public sector in Africa without profit since 2001.

Artemisinin is a compound derived from the sweet wormwood plant and has been used for Centuries in traditional Chinese medicine to treat fever. An ACT is a combination of two or more drugs (one of which is an Artemisinin derivative) that have different modes of action.

Studies have shown that using two or more drugs in combination has the potential to delay the development of resistance. ACTs in particular have been found to be highly effective in treating malaria and their potential to delay resistance in areas of intense transmission is under investigation.

8 July, 2014.

 

 

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