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Release issued 19th December 2002
DALLAS, TEXAS, December 19, 2002, ACCESS PHARMACEUTICALS, INC. (AMEX: AKC) today announced that Zindaclin® has received approval in eight additional European markets. Recently, several international license agreements for the marketing of Zindaclin® have been executed and it is anticipated that the execution of numerous additional license agreements will take place in the near term.
The European approvals include Germany, which triggers a milestone payment under the previously announced Fujisawa License Agreement for European marketing rights. The Company anticipates that Zindaclin® will be launched in Germany and Ireland in the first half of 2003 resulting in an additional milestone payment. Regulatory activities are ongoing to achieve product approvals throughout the remainder of the European Union
Commenting on the Announcement, Kerry P. Gray, President and CEO of Access, stated, "This is another important step towards the global marketing of Zindaclin®. The approval and launch of Zindaclin® in Germany is significant in that not only does it immediately generate revenue from milestone payments but will commence a royalty stream from another major market."
The Company's licensee for this product, Strakan Ltd., has a very active outlicensing program to appoint marketing partners throughout the world. The results of these activities are now being realized with the execution of license agreements for three additional territories, Israel, Cyprus and Turkey, and license agreements for up to six additional markets are expected in the near term. Under the terms of these agreements, Access will receive licensing fees, milestone payments and royalties on product sales.
Mr. Gray continued, "The expansion of the licensing of Zindaclin® throughout the world and the interest being expressed by potential partners confirms the benefits of this technology relative to competitive acne products as well as the market potential for this once daily treatment. Although no one agreement represents significant revenue potential, the combination of numerous agreements are expected to contribute to a meaningful revenue stream."
Access Pharmaceuticals, Inc. is an emerging pharmaceutical company focused on developing both novel low development risk product candidates and technologies with longer-term major product opportunities. Access markets Aphthasol®, the only FDA-approved product for the treatment of canker sores, and is developing products for mucositis and other dermatological indications. Access is also developing unique polymer platinates for use in the treatment of cancer and has developed, in conjunction with its partner Strakan, Ltd., the marketed product Zindaclin®, which utilizes ResiDerm®, its topical zinc delivery system that provides rapid delivery and reservoir of a drug in the skin.
This press release contains certain statements that are forward-looking and that involve risks and uncertainties, including but not limited to the uncertainties associated with research and development activities, clinical trials, our ability to raise capital, the integration of acquired companies and technologies, the timing of regulatory approvals, dependence on others, collaborations, future cash flow, the timing and receipt of licensing revenues, the future success of the Company's marketed products Aphthasol® and Zindaclin® and products in development including polymer platinate, OraDiscTM and our Mucositis technology and other risks detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2001, and other reports filed by us with the Securities and Exchange Commission.
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