Access Pharmaceuticals, Inc. Announces Agreement With Block Drug Company for the International Rights to Amlexanox
DALLAS--(BW HealthWire)--June 4, 1998--Access Pharmaceuticals, Inc. (OTC/BULLETIN BOARD:AXCS) today announced that it has signed an agreement to license from Block Drug Company the rights to amlexanox oral paste 5% for all markets excluding The United States, Japan and Israel.
Amlexanox oral paste 5% is currently marketed in The United States by Block Drug Company under the trademark Aphthasol(TM). Aphthasol(TM) was launched to the dental market in December 1997 and will be launched to general practice physicians in June 1998. Amlexanox oral paste 5% was jointly developed by Access Pharmaceuticals, Inc. and Block Drug Company and subsequently purchased by Block Drug Company with Access receiving royalty payments.
Aphthasol(TM) is the only prescription drug approved by the FDA for the treatment of aphthous ulcers, a condition reported in at least 20% of the general population. Market research in the U.S. indicates that approximately 33% 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 with Block Drug Company, 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.
Commenting on the agreement, Kerry Gray, president and CEO of Access Pharmaceuticals, stated, "Access is committed to maximizing the revenue from this opportunity by aggressively outlicensing this product and developing new line extensions. The near-term revenues to be generated from this opportunity will contribute to the realization of our objective of becoming a profitable emerging pharmaceutical company."
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. This is the first step towards achieving European Community registration. Upon approval of the product in the U.K., a dossier will be submitted to the centralized European authority for review, with the U.K. acting as the sponsor country. |
