Aphthasol was launched to the dental market in December 1997 and will be launched to general practice physicians in June 1998. Aphthasol is the only prescription drug approved by the FDA for the treatment of aphthous ulcers, a condition reported in at least 20 percent of the general population. Market research in the U.S. indicates that approximately 33 percent of this group experience continued episodes of the condition and are candidates for this product.
Initial indications are that the product is being well received by dentists.
Under the terms of the agreement, Access will share in the revenues generated from international licensing activities and Access will assume the international responsibility for licensing, regulatory approval and new product development. Certain regulatory and development costs will be shared. Access has commenced initial development activities to expand the product line for amlexanox products. These developments include alternative delivery vehicles and line extensions to further improve patient benefits. Regulatory activities have commenced in the U.K., where it is anticipated that the product license application will be submitted prior to the end of June.