Grass allergy vaccine data imminent

AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies. Pollinex Quattro (PQ) Grass, the subcutaneous allergy immunotherapy (AIT), continues to gain market share despite being available in the EU only on a ‘Named-Patient’ basis. Trials designed to obtain regulatory approval as a biologic for PQ Birch in Europe, and for PQ Grass in both Europe and the US, are well advanced. Recruitment to the Phase II PQ Grass trial is complete: more than 440 patients have undergone conjunctival provocation testing in a placebo-controlled, dose-response and safety study. Data are now expected in early 2H calendar 2018.

• Strategy: AGY is a fully integrated pharmaceutical company focused on the treatment of allergies. There are three parts to its strategy: continued development of its European business via investment or opportunistic acquisitions; the US PQ opportunity; and further development of its pipeline.
• Allergy immunotherapy: AIT is an option for severe allergies where symptoms are not adequately controlled by traditional products for symptomatic relief. It involves a course of prophylactic immunisations in order to reduce allergy severity. PQ Grass is a short-course, subcutaneous AIT (SCIT) for allergic rhinitis.
• PQ Grass trial: As part of the new clinical strategy, redesigned with the FDA following unexpected results from a US dose-finding study, recruitment has been successfully completed for the Phase II G205 PQ Grass study. This is evaluating dose-response and safety towards licensing applications in the US and Europe.
• US market: AGY anticipates that the US will be the main market for PQ Grass, with potential peak sales of $300m-$400m from grass AITs. The overall US AIT market is estimated at $2bn. Preference for route of administration differs among territories, e.g. subcutaneous injection in the US vs. sublingual in France.
• Investment summary: AGY is going through an exciting period, with a clear vision, gaining market share from competitors, and leading the race to have its products fully approved and regulated as biologicals – first in Europe, and then in the US, where the regulators are demanding change. Read-out from the EU Phase III PQ Birch trial in 2018 will provide the next major value inflection point.