Healthcare Business

When Data Conflicts: Is the Malaria Vaccine Data Good or Bad?

A malaria vaccine is supposed to be a good thing. Right? Unfortunately that all depends. GlaxoSmithKline PLC (NYSE: GSK) currently plans to seek marketing approval for the first malaria vaccine next year. The British drug giant’s drug trial data showed that the shot did lower the number of malaria cases in African children in a multi-site test of over 15,000 children in seven countries. So why is there a controversy over whether this is good or bad?

The Globe and Mail reported that the vaccine showed after 18 months of follow-up to have cut the number of malaria cases in young children in the trial by almost half. It was also shown to have cut about one-fourth (27 percent) of the number of malaria cases in infants.

Then the report from FierceVaccines says that the late-phase data “has tempered expectations for GlaxoSmithKline’s malaria vaccine.. while the vaccine prevents fewer cases than hoped and immunity wanes, it still has the potential to cut incidence of disease.”

The latest study data will be used as the basis for a regulatory application to the European Medicines Agency in 2014. It now appears that Glaxo’s drug submission could allow this malaria vaccine to arrive in 2015, but that timeline assumes that all goes as planned. If you have dealt with EMA and FDA reviews for very long you know by now that things do not always go as planned. That is true even on the good results.

If you have traveled to many developing nations, you know that malaria is not just something that you had to worry about back in the 1800s and early 1900s. The international figure used frequently is that there are over 600,000 deaths per year caused by malaria.

Another issue is that GSK will reportedly only sell the vaccine for 5% over the cost to manufacture the vaccine. GSK has close to $350 million invested into this vaccine so far and the cost could rise to $600 million before it is all said and done. That figure does not include the $200 million or so that the Bill & Melinda Gates Foundation has committed.

Another company called Agenus Inc. (NASDAQ: AGEN) shows that its Agenus’ QS-21 Stimulon adjuvant is contained in this same vaccine. Glaxo’s ADRs in New York are down 0.8% at $49.72 against a 52-week range of $41.68 to $54.00.

Meanwhile, Agenus shares are up 9.3% at $3.05 against a 52-week range of $2.45 to $5.40. We would note that with a mere $90 million market cap, GSK is literally more than 1,000-times the size of Agenus. It is also troubling to see that Agenus’ shares gapped up to $3.30, traded up as high as $3.49 in the first few minutes of trading, and ultimately slid down hard to under the opening gap-up price and then slid some more. That is what technical traders or chartists call a “gap and crap” trading pattern.

This is one of those instances where good news may be news that is more mixed and uncertain rather than the home run that this first sounded like. It is unfortunate that this is the case because there are millions upon millions of people who need this vaccine each year.