Table 2 Relative product positioning for the fixed-dose artemisinin combination therapy, highlighting the differences between the medicines

Partner

Novartis, MMV

Sanofi, DNDi, (MMV)

sigma-tau, Pfizer, MMV

Shin Poong, MMV

Farmanguinhos/DNDi, Cipla; Mepha

AMMS, Kunming Pharma Corp

Trade name

Coartem^®; Coartem-^® Dispersible

Coarsucam^®; ASAQ-Winthrop^®

Eurartesim^®

Pyramax^®

ASMQ

ARCO^®

Approval Date

1Q'01/1Q'09 Swiss-Medic

2Q'07 Morrocco Prequalified 4Q’08

4Q'11 EMA

1Q'12 EMA and Prequalification

2Q'08 Brazil Prequalification anticipated

2005 China

Stringent Approval

Yes: CH, US-FDA, WHO Prequalified

No: Morocco, WHO Prequalified

EMA Submitted; approved by the CHMP in Jun 2011, and EU in Oct 2011

EMA Submitted. Approved by the Korean FDA in Aug 2011; approved by EMA in Feb 2012

Farmanguinhos/DNDi No: Brazil, WHO Prequalification submitted; Mepha product approved in West Africa and Portugal

No: Sino-FDA for the moment

Formulation

Tablet (adult), dispersible flavoured tablets (child)

Dispersible tablets for all ages

Tablet (adult, child), dispersible formulation for children (submission in 2014)

Tablet (adult), sachet with granules (child), (submission in 2014)

Tablet (adult, child)

Tablet (adult, child)

Key Strengths

350 million treatments to date. Paediatric formulation is dispersible and flavoured

First line therapy in francophone Africa. Three-year shelf life. Once per day, three days. Paediatric dose.

Once per day, three-day treatment course. Long terminal half-life of piperaquine. Strong post-treatment protection of 42 days

Once per day, three-day treatment. Granulated paediatric formulation with taste-masking. Best preclinical and clinical data against Plasmodium vivax.

Once a day, three-day treatment. Strong post-treatment prophylaxis. Active against chloroquine resistant P. vivax.

Single dose treatment, may be split over two days.

Key Weakness

Twice per day

Amodiaquine resistance in some countries. GI adverse events

Previous concerns on stability, but data now support two years under Zone IVb conditions

Tablets can only be given to patients >20 kg. Limited repeat dose data. Currently only recommended for a single treatment

Psychiatric and GI adverse events. Mefloquine-resistant strains exist. Concern over use where mefloquine prophylaxis is recommended. Currently relatively expensive ($2.50)

No GCP clinical studies or safety data. Insufficient information on ARCO for children. No stringent regulatory approval

Market size & strength 2010

First line treatment in 35 countries. 82 million treatments (37 million Coartem-^® Dispersible) per year. Estimated 21 million are generic artemether/lumefantrine.

45 million (fixed-dose combinations). First line treatment in 17 countries (West Africa)

Two million treatments per year. Registered in 30% of African countries. First line therapy in Cambodia, on treatment guidelines in six countries

Not launched yet. Should be medicine of choice in Asia/Pacific dual-infection areas.

Still relatively small (200,000 treatments). An Indian approval would significantly change this.

Registered in more than 10 countries. Treats one million patients per year.

Stability

24 months

36 months

24 months

24+ months

36 months (Brazil)

Unknown

Public sector pricing (USD)

$0.74 weighted average (from $0.37-$1.41 depending on weight)

$0.60 weighted average (from $0.30-$1.50 depending on weight)

Estimated $0.90-$1.10 weighted average (from $0.50-$1.50 depending on weight). Final price may be higher due to DHA prices

$1.10 weighted average (from $0.34-$2.12, lowest to highest weight band). Final price may be higher due to artesunate prices

Currently at $2.50 per adult. New mefloquine synthesis should make the price similar to other ACT

Not sold in the public sector.