Shareholders in allergy vaccine developer Allergy Therapeutics were making hay Tuesday after the US Food and Drug Administration (FDA) signalled the imminent lifting of the clinical hold on three of the company's products.

The FDA said the clinical hold on the Investigational New Drug applications (INDs) for the three grass MATA-MPL (Modified Allergen Tyrosine Absorbate-Monophosphoryl Lipid A) formulations of its Pollinex Quattro injection vaccine will be lifted once the protocols have been agreed.

As a part of the normal process the FDA has asked the company to submit its study protocols to the INDs for further discussions in order to provide review and feedback on the proposed studies.

The lifting of the clinical holds was expected, and foreshadowed in an announcement by Allergy Therapeutics in late March.

The FDA's decision clears the way for the development programmes for the three products, intended for the treatment of allergic rhinoconjunctivitis due to grass, trees and ragweed pollen, to restart.

Manuel Liobet, chief executive of Allergy Therapeutics, welcomed the FDA's decision, adding: "It is also encouraging that we will receive comments and feedback on our proposed study protocols from the FDA prior to restarting the development programmes. The company is now moving ahead to identify a development and commercial partner in the US."

"We expect the commercialisation of Pollinex Quattro in the US and further afield to be transformational for the company," chairman Peter Jensen declared.

"Allergic rhinoconjunctivitis affects millions of people in the US, with an estimated 2.7 million receiving allergy vaccines annually. According to independent reports, the US market has the potential to be worth $1.5-$2.0 billion a year and the company is well placed to develop products for this exciting new market," Jensen added.

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