Allergy Therapeutics (AIM:AGY) has turned to public investors for £20 million ($30 million) to move its subcutaneous immunotherapy allergy vaccine through late-phase development. The cash will fund Allergy Therapeutics' attempt to bounce back from the 5-year clinical hold of its U.S. trial program.
|Allergy Therapeutics CEO Manuel Llobet|
The FDA initiated the clinical hold on Pollinex Quattro Grass in 2007 after a trial participant reported numbness and weakness. At the time, the regulator was particularly concerned about the side effects of novel adjuvants and took until 2012 to lift the hold. Worthing, United Kingdom-based Allergy Therapeutics had hoped getting the regulatory green light would enable it to snag a partner to commercialize the vaccine in the U.S., but three years later it is still flying solo.
Now, with the FDA reviewing Allergy Therapeutics' protocol and statistical analyses, the U.S. clinical trial program is on the cusp of getting back on track. And despite the delays, Allergy Therapeutics thinks there is still pent up demand for its grass vaccine in the country. "We have the opportunity to be the first FDA-licensed seasonal subcutaneous immunotherapy allergy vaccine, and so access an estimated $2 billion market," Allergy Therapeutics CEO Manuel Llobet said in a statement.
To reach that point, Allergy Therapeutics has placed enough shares to net it the £20 million it needs for the clutch of studies requested by the FDA. An environmental exposure chamber Phase III efficacy trial--which puts participants in contact with allergens--and a patient registry study are requirements of the biological licence application. Allergy Therapeutics also plans to run safety and pilot studies to assess the dosing of Pollinex Quattro Grass.
If everything goes according to plan, Allergy Therapeutics will begin selling Pollinex Quattro Grass in the U.S. in 2019 and become a financially self sustaining business. Since going public in 2004, Allergy Therapeutics has raised cash through placements several times, one of which saw Chile-based CFR Pharmaceuticals become the majority shareholder. CFR was bought out by Abbott Laboratories ($ABT) last year, making the healthcare giant the controlling shareholder in Allergy Therapeutics.
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