Allergy Therapeutics' US plans back on track

The UK's Allergy Therapeutics is on course to start trials of a grass pollen allergy immunotherapy (AIT) in September that is central to its plans to unlock the US market.

The company already makes significant revenues from the sale of its Pollinex range of grass and tree pollen vaccines in Europe – particularly in Germany – with sales currently running at around £60 million a year and set to be boosted by the company's acquisition of Italian AIT company Alerpharma last month.

Analysts at Edison suggest, however, that approval of the Pollinex Quattro grass allergy product in the US will be a turning point for Allergy Therapeutics and allow it to capture a "large share" of a US market for AIT, estimated to be worth around $2 billion, with some three million people seeking treatment every year.

That would be a major turnaround for the company, which has only recently emerged from a five-year clinical hold on the Pollinex Quattro programme introduced in 2007 after a patient in a study reported numbness and weakness.

The hold was lifted in 2012 but the programme remained stalled until last month, when the company agreed a fresh protocol with the FDA allowing it to start pivotal trials.

The product is in line to be the first subcutaneous seasonal AIT licensed in the US and its short treatment course – coupled with US physicians' preference for aluminium-free vaccines and a solid evidence base from Europe – will encourage rapid take-up, they suggest.

While 'home-brewed' AIT treatments for grass pollen allergies are available, they can take many months to have an effect; Pollinex Quattro requires a course of injections over just three weeks.

Sublingual grass pollen allergy products have been launched in the US by ALK Abello, Merck & Co and Stallergenes after approvals in 2014, but these require daily administration throughout the pollen season. It remains to be seen whether patients and physicians will favour the oral or subcutaneous options, although Edison is convinced the latter will win out.

Armed with £20 million from a fund-raising completed in April, Allergy Therapeutics has hired contract research organisation Inflamax Research to carry out the US clinical trials, which could lead to the product getting approved in 2018.

Once additional Pollinex products targeting tree pollen and ragweed allergies also gain US approval the company could eventually approach $1 billion in sales, says Edison, which counts Allergy Therapeutics among its research clients.

Earlier this week, Allergy Therapeutics reported encouraging data from a trial of its house dust mite AIT Acarovac Plus that could expand its product portfolio beyond the treatment of seasonal allergies and into the perennial allergy sector.