Allergy Therapeutics, a UK-based specialist pharmaceutical company focused on allergy vaccination, says that Japan's Pharmaceutical and Medical Devices Agency has agreed to its plans to conduct further trials for the eventual registration of its ultra-short course grass pollen allergy vaccine, Pollinex Quattro.
The substantial data already available for the grass pollen product forms the basis of a bridging program to allow the product to be used now by the Japanese population. Allergy Therapeutics has agreed to submit a Clinical Trial Notification in Japan and has gained a clear understanding of the path to achieve this regulatory goal.
The company plans to proceed with clinical trials when a suitable partner is found. Allergy believes it is in a very strong position to attract potential partners in Japan for its grass and Japanese cedar allergy indications using its Pollinex platform. Keith Carter, chief executive of Allergy, noted that 29 million people in Japan suffer from allergic rhinitis, a significant portion because of pollinosis. "There are currently no equivalent products available to treat the cause of this allergy. These facts, combined with aggressive public health awareness campaigns, contrive to provide a sizeable and readily accessible marketplace," he said.
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