Novartis malaria treatment Coartem® 80/480mg receives WHO prequalification, enabling greater access for patients

NovartisNovartis antimalarial medicine Coartem® 80/480mg has received World Health Organization (WHO) prequalification, making it the first and only high strength (80/480mg) Artemisinin-based Combination Therapy (ACT) antimalarial treatment available for public sector procurement. This new dosage strength*, has the potential to improve malaria management. WHO prequalification of Coartem® 80/480mg now allows for broad-scale public sector procurement, possibly providing access to the treatment to as many as 25 million malaria sufferers across Africa.

"Over the last ten years, Novartis has worked with partners to make Coartem® treatments available to patients in the public sector and through donor-funded private sector programs," said Joseph Jimenez, CEO of Novartis. "WHO prequalification of Coartem® 80/480mg aligns with the longstanding work of the Novartis Malaria Initiative and confirms the company's status as a leading innovator in malaria treatment."

Although preventable and treatable, malaria was responsible for approximately 584,000 deaths in 2013[1]. One Coartem® 80/480mg tablet is bioequivalent to four tablets of Coartem® 20/120mg**[2], resulting in a lower pill burden for patients - six tablets for completion of the course of treatment, compared to the previous 24. Studies have shown that patient adherence to ACTs varies considerably, from 39% to 100%[3]. Failure to complete the full treatment course may reduce treatment efficacy and allow malaria parasites to develop resistance to the drug. The reduction in the number of tablets associated with Coartem® 80/480mg could increase convenience and overcome the challenges associated with therapies that require taking a large number of pills, therefore improving adherence to treatment and clinical effectiveness.

"We welcome the arrival of high-strength Coartem® 80/480mg said Dr Nafo Traoré, Executive Director of Roll Back Malaria Partnership. "By reducing the number of pills that adults have to take, we hope to see better adherence to treatment regimens, helping us to combat this preventable and treatable disease which still kills hundreds of thousands of people."

Coartem® 80/480mg, which received Swissmedic approval in November 2013, was launched in the private sector in Nigeria in late 2013 and has since been launched in more than ten African countries. This latest formulation highlights the efforts of Novartis to expand access to essential malaria treatments for all ages: in 2004 Coartem® 20/120mg was the first fixed-dose ACT prequalified by the WHO and in 2009, Coartem®Dispersible was launched as the first dispersible ACT designed specifically for infants and children. Today, more than 700 million treatments, including 250 million Coartem®Dispersible antimalarials, have been delivered without profit to malaria-endemic countries.

About the Novartis Malaria Initiative
The Novartis Malaria Initiative is one of the pharmaceutical industry's largest access-to-medicines programs, focused on treatment, access, capacity-building and research & development. Over the last decade, the initiative has delivered more than 700 million treatments without profit, mostly to the public sector. Moving forward, Novartis is committed to working towards malaria elimination by driving the development of next-generation antimalarials, with two new classes of drugs currently in Phase II clinical development.

About Novartis
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 and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 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 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world.

* Approved for adults and children (weighing above 35 kg and older than 12 years) with uncomplicated Plasmodium falciparum (P. falciparum) malaria
** Coartem® 80/480mg is made up of 80mg artemether and 480mg lumefantrine. Coartem® 20/120mg is made up of 20mg artemether and 120mg lumefantrine

1. World Health Organization, Malaria. Available at: http://www.who.int/mediacentre/factsheets/fs094/en/ (link is external). Date accessed: April 2015.
2. Lefèvre G. et al, 2013. Evaluation of two novel tablet formulations of artemether-lumefantrine (Coartem®) for bioequivalence in a randomized, open-label, two-period study. Malaria Journal, 12:(312): 1475-2875.
3. Banek K. et al, 2014. Adherence to artemisinin-based combination therapy for the treatment of malaria: a systematic review of the evidence. Malaria Journal, 13(1): 7.

Most Popular Now

Cannabis extract helps reset brain function in psy…

Research from King's College London has found that a single dose of the cannabis extract cannabidiol can help reduce brain function abnormalities seen in people with psyc...

For first time in 40 years, cure for acute leukemi…

Acute myeloid leukemia is one of the most aggressive cancers. While other cancers have benefitted from new treatments, there has been no encouraging news for most leukemi...

Consuming milk at breakfast lowers blood glucose t…

A change in breakfast routine may provide benefits for the management of type 2 diabetes, according to a new study published in the Journal of Dairy Science. H. Douglas G...

New cancer treatment uses enzymes to boost immune …

Researchers at The University of Texas at Austin have developed a new approach to treating cancer using enzyme therapy. The enzyme, PEG-KYNase, does not directly kill can...

Bayer accelerates six new startups

Changing the experience of health: that's the focus of the six startups which the Bayer G4A team has included in the Accelerator program this year. The young companies fr...

Novartis receives European Commission approval of …

Novartis today announced that the European Commission (EC) has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pe...

Shire completes sale of oncology franchise

Shire plc (LSE: SHP, NASDAQ: SHPG) announces today that it has completed the sale of its Oncology franchise to Servier S.A.S. for $2.4 billion. The franchise includes the...

Antioxidant reduces risk for second heart attack, …

Doctors have long known that in the months after a heart attack or stroke, patients are more likely to have another attack or stroke. Now, a paper in the Journal of the A...

SOLAR-1 trial of Novartis investigational alpha-sp…

Novartis today announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint s...

Novartis to divest the Sandoz US dermatology busin…

Novartis today announced it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solids po...

New tablet production facility in Ingelheim: Cente…

Boehringer Ingelheim held a groundbreaking ceremony for the construction of a new production facility for innovative drugs. This new Solids Launch facility will focus on ...

Tezepelumab granted Breakthrough Therapy Designati…

AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab...