Amlexanox, in a 5% paste formulation, is currently the only FDA-approved product to treat canker sores (aphthous ulcers) and is marketed by Block in the US as Aphthasol. Mucositis involves ulceration of the mouth and is a common complication of chemotherapy (approximately 40% of patients) and virtually all patients who receive radiation therapy to the head and neck develop oral mucositis. The SmallCaps report estimates the U.S. market for amlexanox for the mucositis indication to be roughly $250 million and could be even greater if the product were to be used preventatively by cancer patients.

Jeffrey B. Davis, President of SmallCaps Online, stated, "We feel this is great news for Access, as management was able to acquire rights to a valuable product at a very reasonable cost to the company. We also believe that, due to the fact that amlexanox is already marketed for a similar indication and has an excellent safety profile, only an abbreviated Phase III package on mucositis will be necessary to gain FDA approval. We are estimating," Mr. Davis continued, "that Access will file an IND in the US and the UK during the first half of 1999, and that amlexanox for mucositis could receive US, UK and European approval during 2001."