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Biotech / Medical : Access Pharmaceutical (AXCS)

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To: Lawrence Burg who wrote ()8/25/1998 1:05:00 PM
From: leigh aulper   of 68
 
Access Pharmaceuticals, Inc. Announces the Signing of a Development Agreement With Virotex Corporation

DALLAS--(BW Healthwire)--Aug. 25, 1998--Access Pharmaceuticals, Inc. (OTC BB:AXCS) today announced that it has signed a Development Agreement with ViroTex Corporation ("ViroTex") to incorporate amlexanox in the proprietary mucoadhesive technologies being developed by ViroTex.

ViroTex has developed an innovative bioerodible mucoadhesive

("BEMA") delivery system, which is a thin film that adheres to the oral mucosa and erodes over time delivering the drug into the tissue. Also under development is a film forming mucocutaneous adsorption

("MCA") gel that deposits a film upon application to mucosal surfaces adhering well to wet or damp skin, this technology can also be adapted to an aerosol spray delivery system.

Commenting on the Agreement, Kerry P. Gray, President and CEO of Access Pharmaceuticals, Inc. ("Access"), stated "The delivery systems being developed by ViroTex are ideal for amlexanox and should enable Access to further maximize the value of this asset. Scientific advisors have identified numerous oral diseases and conditions that may respond to treatment with amlexanox. The BEMA and MCA delivery vehicles are ideal for investigating the possibility of expanding the indications for amlexanox into other diseases including oral lichen planus, where currently there is no effective treatment."

Jeffrey Soinski, President and CEO of ViroTex, stated "We are very pleased to be working with Access on this project. Pilot formulation work was conducted with the BEMA technology prior to finalizing this Agreement and amlexanox has been successfully formulated into this delivery system. It is anticipated that within 9 months a formulation could be ready for clinical testing."

Block Drug Company ("Block") under the terms of an existing agreement, whereby the international rights to amlexanox were licensed to Access, will have the United States marketing rights to any product developed under the Access Agreement with ViroTex. Access will fund the ViroTex project development activities; however, Block will share in these development costs by way of a reduction in the royalty Access will pay Block for international sales. The international rights will be out-licensed by Access to its amlexanox licensing partners. ViroTex will receive a royalty on all worldwide sales of products incorporating their proprietary technology.

Amlexanox is marketed in the United States under the tradename Aphthasol(TM) by Block. It is the only FDA approved prescription treatment for canker sores in patients with normal immune systems. A European product license application for amlexanox has been filed in the United Kingdom by Strakan Ltd.

This Agreement together with the out-licensing activities and expansion into additional indications forms the basis of the company's strategy to maximize the value of the Amlexanox asset. Expanding indications and introducing new dosage forms with an approved product significantly decreases product development risks and approval timeliness, thus offering potential for near term revenues.
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