- New formulation designed to reduce number of tablets taken per dose.
- Coartem® 80/480 is an easy-to administer medicine that provides effective malaria treatment for both adults and children weighing more than 35kg or above 12 years of age
Nairobi, July 7 2014 –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, and 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.
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.
This press release contains expressed or implied forward-looking statements, including statements that can be identified by terminology such as “potential,” “goal,” “could,” “experimental,” “commitment,” or similar expressions. Such forward-looking statements reflect the current views of the Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results expressed or implied by such statements. These expectations could be affected by, among other things, risks and factors referred to in the Risk Factors section of Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update it in the future.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.
Novartis was named a Super Sector Leader by the Dow Jones Sustainability Index (DJSI) in 2007. In the same year, 66 million patients around the world benefited from Novartis programs valued at USD 937 million. These initiatives range from drug donation and research programs to combat neglected diseases like malaria, tuberculosis and leprosy in developing nations, to patient assistance programs that help cancer patients receive the most innovative and effective treatments available. For further information, please consult http://www.novartis.com.
For more information, please contact www.malaria.novartis.com