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Malaria vaccine Mosquirix from GSK to be launched in three years

Friday, April 24, 2009, 21:31 This news item was posted in Clinical Trials category and has 0 Comments so far.

 

Mosquirix, a vaccine against malaria from GlaxoSmithKline Plc is likely hit markets in three years.

Mosquirix vaccine is currently in final-stage clinical trials, GlaxoSmithKline reported.

Mosquirix will be tested in  some 16,000 children and infants at 11 trial sites in seven countries.

Earlier clinical tests suggest Mosquirix is 50-55 percent effective in preventing episodes of clinical malaria.

Glaxo believes its Mosquirix vaccine has the potential to save hundreds of thousands of deaths and prevent tens of millions of cases of malaria in Africa, if it came out successful in the late-stage studies Mosquirix will reach the market within three years.

The Malaria Vaccine Initiative, which is working with Glaxo and the Bill & Melinda Gates Foundation on the project, has set a target of getting a malaria vaccine that is at least 50 percent effective by 2015 and one that is 80 percent effective by 2025.

“The pivotal Phase III registration trial will be starting within a few weeks,’’ said Glaxo researcher Joe Cohen. “Today that dream of a malaria vaccine is just about to become a reality in a few more years,” added Cohen who has worked on the project for over 20 years.

Mosquirix vaccine is likely to be filed for regulatory approval by GSK in 2011, under a special review procedure established by the European Medicines Agency for products designed for use in the developing world. Based on normal timelines that could see Mosquirix reaching the market in 2012.

GlaxoSmithKline, the world’s second largest drugmaker, has invested more than $300 million in the vaccine to date and expects to invest at least another $100 million.

Mosquirix (RTS,S) uses a recombinant protein that fuses part of the P falciparum circumsporozoite protein (CSP) with hepatitis B surface antigen.

However, Glaxo will be selling Mosquirix vaccine at preferential prices to international groups like the Global Alliance for Vaccines and Immunization, with its target market in Africa.

“We cannot lose money but we don’t need to make money on this,” Jean Stephenne, head of Glaxo’s vaccines unit, stated recently.

Malaria kills around one million people a year — most of them young children in sub-Saharan Africa.

Mosquirix — also known as RTS,S uses a recombinant protein that fuses part of the P falciparum circumsporozoite protein (CSP) with hepatitis B surface antigen.  Combined with a proprietary adjuvant, RTS,S induces production of antibodies and T cells that interfere with the ability of the malaria parasite to infect humans.  Early development of RTS,S was undertaken by GSK in collaboration with the US Walter Reed Army Institute of Research.

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