First Antimalarial Treatments Produced with Semisynthetic Artemisinin Enter Market
Sanofi and PATH has announced the delivery of the first large-scale batches of antimalarial treatments manufactured with a new semisynthetic artemisinin derivative to malaria-endemic countries in Africa. The shipment signals a new era of lifesaving drugs made with safe, high-quality, and affordable artemisinin that is non-seasonal. By complementing botanically derived supplies, the new option can widen access to treatment for millions sickened by malaria every year — most of them young children in African countries.
More than 1.7 million treatments of Sanofi's ArteSunate AmodiaQuine Winthrop (ASAQ Winthrop, fixed dose artemisinin-based combination therapy), manufactured with semisynthetic artesunate in Morocco, are being shipped from Sanofi's distribution center to Burkina Faso, Burundi, Democratic Republic of the Congo, Liberia, Niger, and Nigeria over the next few months.
"This shipment represents a critical step in improving access to effective treatments and combatting malaria in some of the most affected countries in the world," said Dr Robert Sebbag, vice president of Sanofi's Access to Medicines. "Sanofi is proud that these first batches of antimalarial medicines produced with semisynthetic artemisinin derivative are on the way to reaching patients. This milestone is the result of the enduring partnership between PATH and Sanofi that has translated years of effort into lifesaving change."
Both artesunate (the active ingredient produced from semisynthetic artemisinin) and semisynthetic artemisinin have been shown to be identical to those derived from botanical sources. Consequently, there are no changes to the quality of ASAQ Winthrop.
"Semisynthetic artemisinin demonstrates how public-private partnerships, tenacity, and an urgent and shared goal — saving children's lives — can drive promising innovations to transformative global scale," says Steve Davis, president and CEO of PATH. "As we work together toward a world free of malaria, we are thrilled to see this cutting-edge technology reach the people whose lives it can save. We are proud to join Sanofi and our partners in celebrating this achievement."
Artemisinin is a key ingredient in artemisinin-based combination therapies, recommended by the World Health Organization (WHO) as the first-line treatment for infection with the most deadly form of malaria. The existing botanical supply of artemisinin, derived from the sweet wormwood plant, is volatile due to a number of factors, resulting in inconsistent price and periodic shortages. Sanofi is committed to producing semisynthetic artemisinin using a no-profit, no-loss pricing model, and supplying it to WHO-prequalified manufacturers. Multiple sources of high-quality artemisinin can strengthen the artemisinin supply chain, stabilize pricing, and ensure greater availability of treatment to people suffering from malaria.
Last year, PATH and Sanofi launched commercial production of semisynthetic artemisinin at Sanofi's Garessio site in Italy. In May 2013, the WHO's Prequalification of Medicines Programme announced the acceptability of semisynthetic artemisinin produced by Sanofi for use in the manufacture of artemisinin-derived active substances. This decision serves as an endorsement of the quality of semisynthetic artemisinin and minimises the regulatory burden on manufacturers who plan to use it in their products, offering a clear path to a stronger artemisinin supply chain worldwide.
In the future, sustained production of semisynthetic artemisinin can help scale up global efforts to combat malaria. Sanofi currently has the capacity to produce 50 to 60 metric tons annually, which corresponds to a third of the global annual need for artemisinin and translates to up to 125 million lifesaving treatments.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance