[Ip-health] Press release: New study details safety and efficacy of re-treatment with Pyramax®

[Elizabeth Poll]

Dear colleagues,

We have some important news to share with you: a new study published online today in Lancet Infectious Diseases details the safety and efficacy of re-treatment with Pyramax - a once-daily, 3-day treatment for uncomplicated malaria developed by Medicines for Malaria Venture and Shin Poong Pharmaceutical. The findings will help bring the medicine to many more vulnerable patients.

Please find the press release and notes for editors copied below.

Let me know if you have any questions.

Best wishes,
Lizzie



PRESS RELEASE

New study details safety and efficacy of re-treatment with Pyramax®

WANECAM sub-study analysis published today in The Lancet Infectious Diseases

Geneva, 23 October 2015. Interim data from a clinical trial led by the West African Network for Clinical Trials of Antimalarial Drugs (WANECAM) published online today in The Lancet Infectious Diseases supports the safety and efficacy of the artemisinin-based combination therapy (ACT) Pyramax® (pyronaridine-artesunate) when used for the re-treatment of adults and children over 5 kgs with malaria.

Pyramax, developed by Shin Poong Pharmaceutical and Medicines for Malaria Venture (MMV), is a once-daily, 3-day treatment for uncomplicated malaria. In 2012, it became the first ACT to receive a positive opinion under the European Medicines Agency's article 58 process,[1] and is currently indicated for treatment of a single malaria episode in areas of low transmission with evidence of artemisinin resistance.

The WANECAM sub-study data are now being used to support an application for a label change to allow for re-treatment with the medicine and support its use in all malaria-endemic regions including sub-Saharan Africa, where the global burden of malaria weighs most heavily.

"This is an important paper," said Dr Timothy Wells, MMV's Chief Scientific Officer. "It shows that the new medicine is consistently safe and efficacious when given many times over a 2-year period. This is very relevant in parts of the world where children risk being bitten by an infectious mosquito every night, and some get malaria four or five times each year."

The WANECAM trial, a large, phase IIIb/IV multicentre clinical study, led by Prof. Abdoulaye Djimde, University of Science, Techniques and Technologies of Bamako, Mali, was designed to evaluate the safety and effectiveness of ACTs. Over a 2-year period, patients were randomized and treated with the same antimalarial each time they had a malaria episode. The study compares two ACTs which have recently been successfully reviewed by the European Medicines Agency (Pyramax and Eurartesim®, dihydroartemisinin-piperaquine) with ACTs that are standard treatment in the region (artemether-lumefantrine and artesunate-amodiaquine). The sub-study analysis was planned to provide data on the re-treatment of Pyramax to support its wider use.

"This is a major step forward in the fight against malaria in sub-Saharan Africa," said Prof. Abdoulaye Djimde. "The demonstration that Pyramax is well-tolerated when used to treat multiple episodes of malaria will help to bring this new ACT to countries where the current choice of efficacious antimalarial drugs is very limited."

Notes for editors

About the topic

The WANECAM network, which is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and Medicines for Malaria Venture (MMV), includes four West African countries, (three of which participated in the study: Burkina Faso, Guinea and Mali) and four European countries (England, France, Germany and Sweden) that work in partnership as a cross-border research team to contribute to the evaluation of new antimalarial drugs.

Pyramax® is a once-daily, 3-day treatment for uncomplicated malaria caused by the two main species of parasite, Plasmodium falciparum and Plasmodium vivax, in adults and children. It is the first ACT to have been granted a positive scientific opinion from the European Medicines Agency under Article 58, and the first to be approved for treatment of both of these species of malaria.


About Medicines for Malaria Venture (MMV)

MMV is a leading product-development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs.

Since its foundation in 1999, MMV and partners have developed and brought forward five new medicines: Coartem® Dispersible (artemether-lumefantrine), a child-friendly formulation developed with Novartis; Guilin's artesunate injection Artesun® for the treatment of severe malaria; Eurartesim® (dihydroartemisinin-piperaquine) with Sigma-Tau; Pyramax® (pyronaridine-artesunate), co-developed with Shin Poong; and Guilin's sulfadoxine-pyrimethamine + artesunate amodiaquine (SP+AQ) for seasonal malaria chemoprevention, which received WHO prequalification with MMV's support.

Since 2009, over 250 million courses of Coartem Dispersible treatment have been supplied to 50 malaria-endemic countries; and since prequalification in 2010, an estimated 36 million vials of artesunate injection have been delivered, with the potential to save an additional 200,000-240,000 lives compared to treatment with quinine.

Managing the largest portfolio of antimalarial R&D projects ever assembled, of over 65 projects, MMV has nine new drugs in clinical development addressing unmet medical needs in malaria, including medicines for children, pregnant women and relapsing malaria, and drugs that could support the elimination/eradication agenda. MMV's success in research and access & product management comes from its extensive partnership network of over 375 pharmaceutical, academic and endemic-country partners in 50 countries.

MMV's vision is a world in which innovative medicines will cure and protect the vulnerable and under-served populations at risk of malaria, and ultimately help to eradicate this terrible disease.

For more information, please visit http://www.mmv.org

Or contact:
Jaya Banerji
Director Communications and Advocacy, MMV
Mobile +41 79 707 71 81
e-mail: banerjij at mmv.org


About Shin Poong Pharm.Co.,Ltd

Under the management philosophy of 'for the health of the people', Shin Poong Pharm.Co.,Ltd specializes in manufacturing remedy drugs with sincere efforts put into producing every single tablet of life-saving drugs ranging from ingredients to finished products based on our state-of-the-art manufacturing facilities and quality assurance system. We are committed to realizing the spirit of Shin Poong 3V (Vision, Venture and Victory) with top-notch competitiveness based on in-house ingredient synthesizing technologies obtained through rigorous R&D efforts and to further developing the company into the one that receives confidence from our customers and that contributes to promoting the wellbeing of human beings.

For more information, please visit: www.shinpoong.co.kr/

Or contact:
Jangsik Shin
Manager, Pyramax Team, Shin Poong Pharmaceutical Co., Ltd.
Tel: +82 2 2189 3468
Mobile : +82 10 6255 4538
e-mail : jsshin at shinpoong.co.kr

MMV Disclaimer

This document contains certain forward-looking statements that may be identified by words such as 'believes', 'expects', 'anticipates', 'projects', 'intends', 'should', 'seeks', 'estimates', 'future' or similar expressions, or by discussion of, among other things, vision, strategy, goals, plans, or intentions. It contains hypothetical future product target profiles, development timelines and approval/launch dates, positioning statements, claims and actions for which the relevant data may still have to be established. Stated or implied strategies and action items may be implemented only upon receipt of approvals including, but not limited to, local institutional review board approvals, local regulatory approvals, and following local laws and regulations. Thus, actual results, performances or events may differ from those expressed or implied by such statements.
We ask you not rely unduly on these statements. Such forward-looking statements reflect the current views of Medicines for Malaria Venture (MMV) and its partner(s) regarding future events, and involve known and unknown risks and uncertainties.
MMV accepts no liability for the information presented here, nor for the consequences of any actions taken on the basis of this information. Furthermore, MMV accepts no liability for the decisions made by its pharmaceutical partner(s), the impact of any of their decisions, their earnings and their financial status.



Elizabeth Poll | Medicines for Malaria Venture
Editor and Publications Officer
T: +41 22 555 03 17 | M: +41 79 907 59 92
Email: polle at mmv.org

Defeating Malaria Together | www.mmv.org


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