There are 4 products in this portfolio targeted at severe malaria patients. (http://www.mmv.org/research-development/rd-portfolio)
Only one (IV artesunate) has WHO pre-qualification. WHO pre-qualification is critical because without WHO prequalification or stringent regulatory approval, it could not be purchased by international organizations or donor funds and does not reaching this vulnerable (severe malaria) group. The challenge for this product is that IV administration presumably needs to be completed by a medico and these would be largely unavailable in remote locations
Cipla and Strides have entered into a collaboration agreement for artesunate suppositories with MMV to assist in the WHO pre-qualification process. The goal is to achieve WHO-prequalification of a rectal artesunate product by 2016. All well and good but if the severe malaria has gastro-intestinal complications of there are cultural aversion to this drug delivery method than it may fall short.
(http://www.mmv.org/newsroom/press-releases/mmv-announces-collaborations-cipla-and-strides)
SUDA and MMV are in discussions to formalise a relationship to get artimist into pre-qualification status. Able to be administered in rural and remote locations buy (relatively) untrained persons, gastrointestinal complications aren't an issue and it has a long shelf life.
(http://www.sudaltd.com.au/attachments/article/78/731 ArTiMist update 21August2014.pdf)
The final candidate is in early stages. Dilafor has produced a range of heparin analogues with low anticoagulant activity during the selection of a candidate drug (CD) for the treatment of severe malaria. Still in very early clinical trials
So, I expect that getting pre-qualification is going to take some time - probably a couple of years. But the rewards could be substantial. For example, between 2010 and 2014, an estimated 25 million prequalified vials (of Guilin IV drug) had been delivered to malaria-endemic countries.
An announcement confirming the receipt of funds to support the next Phase3 clinical trial will be another reasonable milestone. I say reasonable because it won't necessarily bring income into the stock - although it will certainly save them big dollars - but I suggest that the market isn't overly interested in anything that doesn't immediately show income $.
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