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

WHO prequalified Coartem® 80/480mg is the first and only  high strength malaria treatment available for donor-funded public sector procurement

Coartem® 80/480mg reduces the pill burden for patients, potentially improving adherence to treatment and clinical outcomes

This follows the launch of the first fixed-dose ACT and the first child friendly ACT formulation, underscoring the ongoing innovation of Novartis in malaria treatment

Basel, Switzerland, July 16, 2015 - Novartis antimalarial medicine Coartem® 80/480mg today 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. For more information, please visit: www.malaria.novartis.com.

 

Disclaimer

This press release contains expressed or implied forward-looking statements, including statements that can be identified by terminology such as "potentially," "ongoing," "potential," "possibly," "may," "could," "efforts," "moving forward," "committed," "next-generation," "currently," 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.

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. For more information, please visit http://www.novartis.com.

 

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

 

* 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

References

[1] World Health Organization, Malaria. Available at: http://www.who.int/mediacentre/factsheets/fs094/en/. 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.

Suggested Articles

Merck’s Keytruda went up against chemo in a head-to-head colorectal cancer battle—and won.

While the FDA gave an emergency green light to chloroquine's use against coronavirus, European regulators are restricting the drug to clinical trials.

Biocon has finally satisfied the FDA that its insulin production plant in Malaysia is ready for prime time.