Access Pharmaceuticals, Inc. Announces Filing of Product License Application in the UK and Execution of License Agreement
DALLAS--(BW Healthwire)--Aug. 18, 1998--Access Pharmaceuticals, Inc. (OTC BB:AXCS) today announced that the product license application for amlexanox 5% paste for the treatment of canker sores has been submitted to the UK Medicine Control Agency by Strakan Ltd. the licensee for the United Kingdom and Ireland. Strakan Ltd. and Access have also executed the License Agreement granting Strakan rights to amlexanox 5% paste for the United Kingdom and Ireland.
This filing is an important step in the global commercialization of amlexanox. The UK submission is in the European format, which will be submitted for approval in the EEC member states upon approval in the UK. The registration dossier in this format contains expert reports that are required by numerous regulatory agencies throughout the world, enabling Access to accelerate the registration process in other countries by providing complete registration packages in either the US of European format.
"We are extremely pleased with the progress Strakan has made filing the product license application," commented Kerry P. Gray, President and CEO of Access. Mr. Gray remarked "Adapting the US New Drug Application (NDA) to the European format, having the expert reports completed and obtaining the additional information required by the UK authorities has been a considerable undertaking."
Under the terms of the License Agreement, Strakan Ltd. will be responsible for and bear all costs associated with the regulatory approval process in the United Kingdom and European Community, will pay milestones based on cumulative sales revenue and will pay a royalty on sales.
Mr. Gray continued "Signing the Licensee Agreement is the first step in the international commercialization of this product. Strakan Ltd. has demonstrated a high commitment to this product by filing the product license application prior to the finalization of the License Agreement. Amlexanox represents a significant opportunities for both companies."
Access is currently focused on maximizing the worldwide potential for amlexanox through out-licensing the international rights to the current formulation, developing additional delivery forms and investigating new potential indications.
Access Pharmaceuticals, Inc. is a site-directed drug targeting company using bioresponsive carriers to target and control the release of therapeutic agents into sites of disease activity and clear the non-targeted drug fraction. In addition to amlexanox, Access is developing a unique polymer platinate for use in the treatment of cancer. Access also is developing in conjunction with Strakan Ltd. a topical zinc delivery system called ResiDerm(TM) that provides rapid delivery and reservoir of a drug in the skin. |
