Food Allergies: Drug makers set to capitalize?

Although food allergies have been recognized in the medical community since the beginning of the century, they have recently been receiving much more public attention due to the perceived increasing prevalence of the condition in the US,

Europe and Japan. As new research and treatments emerge, the potential for increased profits in this under-treated area will increase dramatically.

The Market Brief 'Food Allergies: New Treatments Are Nothing To Sneeze At' provides a greater understanding of the evolving status of the diagnosis and treatment of food allergy, which is rapidly changing due to increasing prevalence of the condition and focused research and product development. This analysis provides an overview of the management of food allergies affecting the general population, most notably peanut, seafood and milk allergies.

Growing concern

Media in the US, Europe and Japan have been stating that the prevalence in food allergies is rising rapidly, however, there is little evidence to support these statements. Several studies have shown a trend in the increasing prevalence of food allergy but this data has not been statistically significant. In fact, researchers at John Hopkins University recently found that at least 20% of children with peanut allergy will outgrow their allergy.

The major problem plaguing the epidemiological assessment of food allergy is the lack of accurate diagnostic techniques. Skin-prick testing is the most established form of allergy testing and is a fairly inexpensive test to run. However, the preliminary findings of a study at the 2003 meeting of the American Academy of Allergy, Asthma and Immunology showed that this test is not as reliable as previously thought.

Results of the study showed that individuals who were known to have a food allergy often produced a negative skin prick test. Additionally, skin-prick testing is too dangerous be performed in individuals known to have severe anaphylactic reactions.

New diagnosis

Double-blind food challenges, the gold standard of allergy testing, are highly accurate. However, this method of testing is also expensive and time consuming and should not be used in individuals with a history of severe reactions.

An alternative to skin-prick testing and food challenges is blood testing such as the radioallergosorbent test (RAST) or the enzyme-linked immunosorbent assay (ELISA). These tests measure presence of food-specific IgE in the blood but unfortunately, are much more expensive than skin-prick tests and not considerably more reliable.

However, a study by Beyer et al in the July 2003 JACI found that the measure of peanut peptide-specific IgE was a particularly useful tool for identifying patients with clinical reactivity to peanuts but low levels of peanut-specific serum IgE. This new assay, expected to reach the market in late 2004-early 2005, may reduce the need for peanut food challenges, increasing the utility of diagnostic measures that test for blood IgE.

Demand for prevention

Currently available treatments for food allergy include antihistamines, anti-inflammatory agents (i.e. mast cell inhibitors and corticosteroids), and epinephrine.

All of these treatments are aimed at treating an allergic reaction once it has already occurred. There are few, if any, preventative treatments currently on the market but this is set to change dramatically in the future.

Genentech, Tanox and Novartis currently have two immunotherapies in development for the treatment of food allergy. TNX-901 and Xolair (omalizumab) are both biological therapies that target IgE. In phase II trials, TNX-901 has shown strong efficacy in increasing a patient’s tolerance of peanuts and has potential to be an effective long-term treatment for management of food-induced anaphylaxis.

TNX-901 is set to go into phase III clinical trials for food allergy treatment. Xolair, an asthma drug with a similar mechanism of action, has already been approved for treating asthma and has a large body of safety data backing its use. Genentech, Tanox and Novartis have been in discussions to investigate the use of this drug in treating food allergy as well.

Regardless of which drug the trio chooses to push to market, these novel immunotherapies will be great advances in treatment of food allergies if they continue to perform well in clinical trials.

Short-term work, long-term profit

While new treatment and diagnostic techniques are awaiting approval, manufacturers of marketed products can increase penetration in the near term through targeting areas of high unmet need such as the institution of national guidelines for adrenaline use, and in the education of food allergy sufferers and their families.

A study in the July 2003 issue of Journal of Allergy and Clinical Immunology, for example, found that early exposure to peanut in infants susceptible to peanut allergies might lead to early sensitization and that avoidance of peanuts in these individuals might prevent formation of peanut allergies.

It is important that drug makers involved in the food allergy market continue to sponsor studies such as these that will ease the fears of peanut allergy sufferers and their caregivers.

Pharmaceutical companies should also participate in the work towards stronger enforcement of food labeling laws. Food manufacturers and consumer groups are currently working with the FDA to increase public awareness of the seriousness of food allergen reactions and to ensure that allergens are appropriately labeled in food products. Pharmaceutical manufacturers can increase profits and physician awareness and loyalty by financially backing the efforts of these groups.

If you found this week's Expert View useful, you may be interested in Datamonitor's reports:

• Food Allergies: New Treatments Are Nothing To Sneeze At priced $1,600
• Pipeline Insight: Asthma, COPD and Allergic Rhinitis - The Needs of Severe Patients Must be Addressed priced $4,100
• Strategic Perspectives: Allergic Rhinitis - Impact of a Blockbuster Going Bust priced $6,400

To order these reports contact support@bioportfolio.com or telephone +44 1300 321501 or +1 415 680 2472 and a representative will get back to you.