(Bloomberg Opinion) -- Food allergies alter lives and can have deadly consequences. That’s one of the reasons that full results of a study of Aimmune Therapeutics Inc.’s peanut allergy treatment, published Sunday in the prestigious New England Journal of Medicine, are so exciting.
The findings validated and fleshed out details of the study that were first released in February. The key takeaway: After a year of treatment, two-thirds of children who took the medication were able to eat small amounts of peanuts. This isn’t a cure. But it has a shot at U.S. government approval, and could make the lives of children with few options easier and safer. That gives the medicine huge commercial potential.
Analysts project the drug could generate peak sales of more than $1 billion a year, potentially helping a great number of patients. But even as the new publication highlighted the impressive efficacy of the treatment, it added further weight to concerns among both patients and shareholders about potential side effects and commercial considerations. Aimmune’s shares fell as much as 10 percent on Monday.
This treatment isn’t an antibody or molecule that targets the roots of the problem. Instead, Aimmune has taken a pre-existing method of allergy protection — carefully exposing children to de-fatted peanut flour to desensitize them — and finely tuned it in an effort to pass muster with the Food and Drug Administration. Aimmune produces capsules or sachets with a precise quantity of its drug, which is then mixed into food. The dose is escalated over the course of six months, with the aim of protecting people from the most severe reactions.
The study showed that this can be highly effective for many children. Being able to eat a peanut or two may not permit a change in diet, but the treatment offers protection against potentially deadly accidental exposure and a path toward a less regimented and fearful lifestyle. That’s no small achievement, given that peanut allergies have become increasingly common in America. A recent study found a 21 percent increase in prevalence between 2010 and 2016; by 2020, Aimmune estimates that as many as 1.7 million Americans between 4 and 17 may have a peanut allergy.
Despite the market opportunity, Aimmune’s process isn’t easy on patients, a fact only made clearer with the full study results. Most children on the drug experienced at least one moderate adverse event. Among those in active portion of the study, 14 percent had to use epinephrine, compared to 6.5 percent of those on the placebo, according to the findings released Sunday. More than 10 percent of the children on the drug dropped out of the trial due to side effects. It’s a complicated and potentially scary process to go through, and may not be suitable for everybody.
Investors are concerned that these side effects may fundamentally limit the commercial opportunity for the medicine. And then there’s the tricky matter of taking a modified natural product and charging a premium for it. Patients, physicians and insurers may balk if the treatment is priced aggressively.
Scientific success almost never comes without ambiguity, and that’s certainly the case with Aimmune’s results. But at least some patients who previously had few appealing options have the chance of coming away winners.
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Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.
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