Strong Recommendation for Pyronaridine-Artesunate in Revised World Health Organization (WHO) Malaria Treatment Guidelines Inclusion in latest edition of WHO guidelines for malaria is an important step towards wider use of the drug

MMV (http://www.MMV.org) and Shin Pong Farm. Company Limited, World Health Organization (WHO) Guidelines for Malaria after a comprehensive review process (http://bit.ly/3EZSJep).

The WHO Guidelines for the Treatment of Malaria are the standard reference that guides country-level policies for the management of malaria. New drugs are recommended for inclusion only after a robust and thorough assessment of the evidence using the GRADE (http://bit.ly/3XuGnSy) framework, which is a systematic approach to clinical practice recommendations. provides perspective. Following this review – which included the largest clinical study to evaluate the real-world efficacy and safety of any anti-malarial – the guideline development committee formalized Pyramax into guidelines with a “strong” recommendation. Recommended to include – highest level of confidence.

Piramax is a fixed-dose artemisinin-based combination therapy (ACT) and is the only one specifically indicated for the blood-stage treatment of the two major species of malaria parasite: P. falciparum and P. vivax. This medicine is also available in a child-friendly granule formulation to ensure palatability and hence correct dosage in this vulnerable population.

Received both Pyramax Tablets and Pyramax Granules European Medicines Agency (EMA) Positive scientific opinion from the Committee for Medicinal Products for Human Use (CHMP) via Article 58 on the basis of a robust development programme. To date, more than 2.9 million malaria patients have been treated with this drug, including children less than 1 year old.

Both formulations are currently registered in 29 countries for the treatment of uncomplicated malaria. africa And Asia,

Following positive scientific opinion for use, a large cohort event monitoring study was implemented in 5 African countries [1]Under the supervision of the CANTAM network [2]To evaluate the safety and effectiveness of Pyramax under conditions similar to everyday clinical practice. This study, which reported high effectiveness (D28 PCR-adjusted cure rate of 98.6%), included more than 8,500 acute malaria episodes in 7,154 patients, and has recently been published in PLoS Medicine. [3],

Pyramax was included in the WHO’s List of Pre-eligible Medicines in 2012 and the WHO’s List of Essential Medicines in 2017 for both adults and children. Pyramax has subsequently received a positive WHO review Advisory Committee on the Safety of Medicinal Products in 2019, which included a review of interim data from the CANTEM study.

after this review October 2019 and the next revision of their guidelines for malaria is pending WHO published an information note in support of the use of Pyramax at the country level, stating that “artesunate-pironeridine has been shown to be a safe regimen for the treatment of uncomplicated malaria in adults and children weighing 5 kg and over in all malaria-endemic areas.” and may be considered effective acts. ..Countries may consider including this drug in their national treatment guidelines for the treatment of malaria.”

“Adding Pyramax WHO Guidelines for Malaria is a milestone we are proud to have reached with our long-standing partner Shin Pong Farm. Company Limited,said Dr. david reddyCEO of MMV. “We entered the Pyramax project to help save the lives of adults and children with malaria. Therefore, we continue to work with Shin Pong to register both Pyramax tablets and granules in more malaria-endemic countries. This will facilitate equitable access. An important new addition to the malaria treatment toolkit.”

“The official inclusion of Pyramax in the WHO Guidelines for Malaria is an important step, allowing malaria endemic countries to confidently select Pyramax as a first-line act. The managerial decision to initiate the Pyramax project was made by Shin Pong was based on the core values ​​and company policies that have guided us for more than half a century. We will continue to produce qualified products to provide patients with powerful, reliable, simple treatments.” Shin Pong Farm. Company Limited,

[1] Gabon, Albert Schweitzer Hospital (CERMEL), Lamberene, Côte d’Ivoire: Azagui and Health Center Health Center of Agboville, cameroon: Biotechnology Center, University of Yaounde and MFO District HospitalCongo: For the Congo Foundation medical Research, brazzavilleMakele Hospital, Madibou’s Health CenterDR of Congo: Faculty of Medicine, Kinshasa University, Mont-Amba HospitalKinshasa, Evangelical Medical Institute kimpsey’s

[2] For more information about Cantum, please visit: http://bit.ly/3GGf9CE

[3] To read the Cantum study, please visit: http://bit.ly/3u4n6tD

distributed by apo group on behalf of Medicines for Malaria Venture,

for more information:Elizabeth PoleCommunications Director, MMV
Phone +41 79 709 59 92
E-mail: [email protected]

Accolade Omishop
Associate Director of Communications, MMV
Phone +41 79 896 20 61
E-mail: [email protected]

Background on Malaria Burden
According to the latest World Malaria Report (http://bit.ly/3EIJPRg), released on 6 December 2021In 2020, there were an estimated 241 million cases of malaria and 627,000 deaths worldwide. This represents about 14 million more cases and 69,000 more deaths in 2020 than in 2019. Nearly two-thirds (47,000) of these excess deaths were linked to disruptions in the provision of malaria prevention, diagnosis and treatment due to the COVID-19 pandemic. Furthermore, in the past 2 years, the emergence of parasite mutations associated with drug resistance in africa has been confirmed, delayed parasite clearance (and therefore delayed cure) has already been observed Rwanda, Uganda And this Horn of Africa,

WHO African Region continues to bear a disproportionately high share of the global malaria burden. In 2020, the region was home to 95% of all malaria cases and 96% of all deaths. About 80% of all malaria deaths in the region occur in children under the age of five.

In 2020, six countries accounted for more than half of all malaria deaths worldwide: Nigeria (27%), the Democratic Republic of the Congo (12%), Uganda (5%), Mozambique (4%), Angola (3 more Burkina Faso (3%).

About Pyramax®
a fixed-dose combination of Pyramax, pinoridine and artesunate and the latest ACT combination approved by a strict regulatory authority, Development began in 2000 as a joint venture between Shin Pong Farm. Company Limited, And WHO TDR. Thereafter, development was continued by Shin Pong Farm. Company Limited,The University of IowaAnd Medicines for Malaria Venture (MMV).

This once-daily, 3-day therapy is indicated for the treatment of acute malaria in adults and children over 20 kg (Piramax® Tablets) and in children and infants between 5 and 20 kg (Piramax® Granules).

About Article 58
Article 58 of Regulation (EC) No. 726/2004 establishes a mechanism whereby European Medicines Agency can give a scientific opinion in the context of cooperation with (EMA) World Health Organization ,WHO), especially for the evaluation of certain medicinal products for human use intended for outside markets The European Union,

Article 58 of the regulation responds to the need to protect and promote public health and to give scientific assistance in the context of cooperation to non-EU countries. WHO as well as facilitating faster access to important new medicinal products by those countries.

about Shin Pong Farm. Company Limited,
Shin Pong was established in 1962 with the headquarter located at Seoul, Korea, Shin Pong is one of the largest pharmaceutical companies Korea It produces both active pharmaceutical ingredients and finished pharmaceutical products in facilities for which European Union Good Manufacturing Practices (EU GMP) certification was granted in 2012 for its lead anti-malarial product Pyramax® (pyronaridine tetraphosphate and artesunate).

‘For the health of the people’ is the inspired corporate philosophy of the company. Shin Pong contributed extensively in eradicating parasitic diseases Korea during the 1970s and 80s and from other countries africa, Chinaand through stronger cooperation with Southeast Asian countries World Health Organization ,WHO,

Shin Pong Reach Public Development Partnership to work with its partners to deliver a healthcare model to end the global epidemic of infectious diseases and end-to-end execution from early detection for endemic infections to field implementation was in the lead.

For more information, please visit http://bit.ly/3OOIY6d

about Medicines for Malaria Venture (MMV)
MMV is a major Product Development Partnership (PDP) in the area of ​​anti-malarial drug research and development. Its mission is to reduce the burden of malaria in endemic countries by facilitating the discovery, development and distribution of new, effective and affordable anti-malarial drugs.

MMV receives funding and support from government agencies, private foundations, international organizations, corporations, corporate foundations, and private individuals. These funds are used to finance MMV’s portfolio of R&D projects as well as specific, targeted access and product management (APM) interventions aimed at increasing access to malaria drugs by vulnerable populations in endemic countries and to support their proper use.

Since its foundation in 1999, MMV and partners have built the largest portfolio of antimalarial R&D and access projects ever assembled and have advanced 15 new drugs. Nearly 3 million lives have been saved by these MMV co-developed drugs. MMV’s success is based on its extensive partnership network of approximately 150 active partners, including those from the pharmaceutical industry, academia and endemic countries.

MMV’s vision is a world in which innovative medicines will treat and protect vulnerable and underserved populations at risk of malaria, and ultimately help eliminate this terrible disease.

For more information, visit http://www.MMV.org

MMV Disclaimer
This document contains certain forward-looking statements that can be identified by words such as ‘believes’, ‘expects’, ‘estimates’, ‘projects’, ‘intends’, ‘should’, ‘expects’, ‘estimates’, ‘future’ Is. ‘ or similar expressions, or by discussion of vision, strategy, goals, plans, or intentions, among other things. This includes hypothetical future product target profiles, development timelines and approval/launch dates, positioning statements, claims and actions for which relevant data may still need to be established. The stated or implied strategies and action items may be implemented subject to approval, including, but not limited to, local Institutional Review Board approval, local regulatory approval, and compliance with local laws and regulations. Thus, actual results, performance or events may differ materially from those expressed or implied by such statements.

We ask you not to place undue reliance on these statements. Such forward-looking statements reflect the current views of Medicines for Malaria Venture (MMV) and its partners make forward-looking statements regarding future events, and involve known and unknown risks and uncertainties.

MMV accepts no liability for the information presented herein, nor for the consequences of any actions taken based on this information. Furthermore, MMV accepts no liability for the decisions made by its pharmaceutical partner(s), the effect of any of their decisions, their earnings and their financial condition.

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