Stallergenes is looking to get a foothold in the USA following a filing across the Atlantic of the French drugmaker's flagship allergy product Oralair.
The company notes that the US Food and Drug Administration has accepted for review its Biologics License Application for Oralair, its five-grass pollen extract allergen immunotherapy sublingual tablet. The product has been marketed in Europe since 2008, has recently made a positive start in Australia/New Zealand and Russia and was launched a few months ago in Canada.
The latter green light makes Oralair the first allergen immunotherapy tablet to be marketed in North America, but it is the USA that offers "substantial potential", Stallergenes says. Allergic rhinitis affects 60 million people and the most prevalent allergen is grass pollen, the firm notes, but less than three million sufferers are treated by allergen immunotherapy.
The current standard of care in the USA for immunotherapy is multiple injections of allergens performed in a supervised medical setting, the Paris-headquartered firm states. There is, therefore, "a strong need for an innovative sublingual treatment in the USA, as currently approved allergen immunotherapy is not available for patient self-administration".
Chief executive Roberto Gradnik said that "acceptance of the BLA filing for our tablet in the USA…is fully consistent with our drive for innovation and is a major step in Stallergenes’ international growth strategy". Speaking to PharmaTimes World News last year at a meeting in London, he stated that acquisitions are also part of that strategy.
Stallergenes shares rose 8.4% to 49.85 euros as investors believe the company has stolen a march on rival ALK-Abello (and the latter's partner Merck & Co) in getting a sublingual immunotherapy tablet in front of the US regulator.