Access Pharmaceuticals, Inc. Announces Signing of Agreement for UK and Ireland for Marketing Rights for Amlexanox
DALLAS--(BW HealthWire)--July 28, 1998--Access Pharmaceuticals, Inc. (OTC BB:AXCS) today announced that it has signed a binding Letter of Intent with Strakan Limited to license amlexanox 5% paste for the treatment of canker sores for the United Kingdom and Ireland. Amlexanox, marketed in the U.S. by Block Drug Company under the tradename Aphthasol(TM), is the only FDA approved product in the U.S. for the treatment of canker sores.
Under the terms of the agreement, Strakan Limited 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.
Commenting on the Agreement, Kerry Gray, President and CEO of Access Pharmaceuticals, stated, "This is an important step in the international commercialization of amlexanox. Strakan has a highly experienced regulatory group that has successfully registered many products through the European multi-state process. Market surveys indicate the market potential for amlexanox in the UK could exceed $25 million which is proportionate in size to the estimated potential market in the U.S. of $300 million."
Harry Stratford, President of Strakan, stated, "The UK product license application will be filed in July. Market research studies and pre-marketing activities for the product launch have commenced. This is a major opportunity in a market where there is a need to improve therapy."
The filing of the UK product license application is the first step in the European Community multi-state registration process. Upon approval in the UK, Strakan will file the registration package with the European Authorities and will act as sponsor for the approval process. Approval in Europe is anticipated in 1999.
Access is currently out-licensing the international rights to amlexanox. The initial focus is to license the European and Canadian rights where the market opportunity is comparable to the United States.
Access Pharmaceuticals, Inc. is a site-directed targeting company using bioresponsive drug 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 a topical zinc delivery system called ResiDerm that provides rapid delivery and reservoir of a drug in the skin. |
