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Pyramax® is a path-breaking drug to treat malaria.
It is the:
- First artemisinin combination therapy (ACT) to receive a positive scientific opinion under Article 58* from the European Medicines Agency (EMA)
- First new Korean medicine, developed by Shin Poong Pharmaceutical Co Ltd and Medicines for Malaria Venture (MMV) to be approved by the EMA
- First ACT to receive an Article 58 positive scientific opinion from EMA for the treatment of both strains of malaria: P. falciparum and P. vivax, in adults and children over 20kg
Pyramax was added to the list of WHO-prequalified medicines in May 2012.
Public health need for Pyramax
- ACTs are the cornerstone of antimalarial treatment since WHO’s 2002 recommendation to replace existing therapies with artemisinin combination therapies
- ACTs are now used to treat malaria in 88 malaria-endemic countries6
- Currently the only fixed-dose ACTs approved by stringent regulatory authorities are Coartem®/ Coartem® Dispersible (artemether-lumefantrine) and Eurartesim® (dihydroartemisinin-piperaquine)
- Antimalarials have been shown to be failing in the Mekong region. A new medicine with ingredients not widely used in the region is urgently needed to help remove drug pressure on existing ACTs used in the region
- Pyramax offers a new alternative in countries with low malaria transmission where the risk of re-infection is low and where there is documented or suspected resistance to artemisinin and diminished efficacy of other ACTs.
- Treatment-emergent adverse events (AEs) reported for ≥5.0% of subjects in any treatment group across all Phase II/III studies were headache (10.6%) and cough (5.9%) in the Pyramax group; headache (10.4%) and dizziness (6.6%) in the MQ + AS group; cough (9.1%), headache (7.6%), abdominal pain (5.1%), and upper respiratory tract infection (5.1%) in the AL group; headache (14.4%) and myalgia (8.6%) in the chloroquine group.
- Liver enzyme elevations were noted in some patients, but also after retreatment in a few healthy volunteers. As a result, until further data after retreatment is obtained, it is recommended that Pyramax be administered not more than once.
Malaria burden on poorer countries of the world5
- Over 650,000 people die of P. falciparum and P. vivax malaria annually.
- Over 3 billion are at risk of P. falciparum.5
- Three billion people are at risk of P. vivax1, the neglected species of malaria that leads to more than 80 million clinical episodes a year2 and can cause severe or even fatal episodes, with incidence and mortality rates similar to those for P. falciparum.
- Nine out of ten malaria-related deaths occur in sub-Saharan Africa and 86% of those occur in children under the age of 5.5
Growing resistance to artemisinin
- As ACTs become more broadly established they will confront increasing selection pressure from biological as well as societal causes3
- Early indications of the development of artemisinin resistance in the Greater Mekong region has required a focused drive by WHO to protect this class of drug with a Global Plan for Artemisinin Resistance Containment4
- The S.E. Asia experience highlights the need for continued development of alternative antimalarials and new treatments using existing drugs
- Currently there are no viable alternatives to ACTs that constitute safe, efficacious and sustainable treatment for P. falciparum malaria4
- In a September 2011 update on artemsinin resistance, WHO articulated the need for new treatment alternatives for Cambodia given the alarming rise in treatment failure. It listed pyranoridine-artesunate (Pyramax), quinine doxycycline for 7 days, and atovaquone-proguanil + primaquine as potential options.
Controlled registration and launch of Pyramax
Shin Poong will engage in a phased approach to the roll out of Pyramax in endemic countries, based on the EMA’s Article 58 positive opinion:
- Incorporation into WHO Artemisinin Resistance Containment Programmes in selected S.E. Asian countries
- Submission to the WHO Essential Medicines List, Standard Treatment Guidelines and Prequalification
- Initial submission to national authority registrations in countries with reported resistance to artemisinin for public market launch
- Article 58 opinion variation for expanded label based on anticipated date from pharmacovigilance trials, including repeat dose.
- Shin Poong commits to establishing the lowest possible price for Pyramax in malaria-endemic countries, to facilitate maximum access and compete favorably with prices for currently marketed artemisinin combination treatments (ACTs).
- Shin Poong will ensure appropriate use
- Information on correct use and dosing limits will be communicated to prescribers and containment project managers
- Pyramax packaging is designed to improve patient compliance.
Value of partnership and collaboration
Development of Pyramax was made possible thanks to the partnership between MMV and Shin Poong.
- MMV took over the Pyramax project from WHO/TDR in 2002, when it was just entering preclinical trials, and embarked on a partnership with Shin Poong.
- Ten years on, the commitment of this partnership to the development of a new antimalarial has paid off, with the EMA approval of Pyramax. The drug will be used to treat both strains of malaria, as well as help in the containment of the disease in S.E. Asia.
- The approval of Pyramax has proved that drug development partnerships can not only succeed but can truly advance the fight against malaria.
- The development of this new ACT was made possible thanks to investment from the public, philanthropic and private sectors and the commitment of the two main partners, Shin Poong and MMV.
MMV’s commitment to malaria research
- MMV continues to work to develop new medicines to counter resistance, stop transmission and provide a radical cure for P. vivax malaria.
- Our ultimate goal is a one-dose cure that will help eradicate this deadly disease.
* What is Article 58?
Article 58 of Regulation (EC) No 726/2004 was created in 2004. Technically, it establishes a mechanism for the European Medicines Agency to give a scientific opinion, in cooperation with the World Health Organization (WHO), for the evaluation of medicinal products intended exclusively for markets outside the (European) Community7 .
1. Baird, J.K., 2010. Eliminating malaria – all of them. The Lancet, 376, pp. 1883-1885
2. Bassat, Q. & Alonso, P., 2011. Fathoming severe Plasmodium vivax disease. Nature Medicine, 17(1), pp. 48-49.
3. NIAID, 2011. Antimicrobial (Drug) Resistance.
4. ACT Resistance Report, Geneva: WHO, 2011.
5. World Malaria Report, Geneva: World Health Organization, 2011.
6. WHO, 2012. Country antimalarial drug policies by region.
7. EMA Article 58.