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Zambon Group signs amlexanox licensing agreement with Access Pharmaceuticals Inc

Release issued 14th January 2003

Zambon Group S.p.A. and Access Pharmaceuticals Inc. (AMEX: AKC) have announced the signing Licensing Agreement granting Zambon Group the marketing rights for amlexanox for the treatment of canker sores. This Agreement grants an exclusive license for France, Germany, Holland, Belgium, Luxemborg, Switzerland, Brazil and Columbia and a semi-exclusive license for Italy. There is also a provision in the Agreement to further extend the territory.

The rights granted are for amlexanox 5% paste, the product currently marketed in the United States and approved in the United Kingdom, and OraDiscTM the product candidate currently in Phase III clinical testing. In addition, Zambon has the rights to any future product improvements for amlexanox for the treatment of canker sores. Under the terms of this Agreement, Zambon will pay an upfront licensing fee, will make milestone payments and will purchase the finished product from Access for sale in the territory. Zambon has been granted the right to manufacture the product for Brazil and Columbia.

Commenting on the Agreement, Kerry P. Gray, President and CEO of Access, stated "As a result of this Agreement, amlexanox is now licensed in all European Union markets, with the exception of Austria. Zambon is a highly successful pharmaceutical company with a rapidly growing presence throughout Europe. This Agreement is a very important step in maximizing the revenue potential for amlexanox in the European Union.

Roberto Rettani, CEO Zambon Group, stated: "Amlexanox represents a significant opportunity to expand our pharmaceutical business in our European subsidiaries with an exciting new product. The high incidence of recurrent aphthous ulcers makes this an attractive product opportunity. Once the product is approved in Europe, we look forward to establishing amlexanox as the market leader in this segment."

Clinical studies have shown that if the product is applied at the first sign or symptom of the disease the onset of the ulcer can be aborted, but if an ulcer develops it is significantly smaller, less painful and heals in approximately four fewer days compared with no treatment. Amlexanox is the only clinically proven product approved by the FDA for the treatment of aphthous ulcers. The medical literature and market research indicates that approximately 15 percent of the population suffer from this condition.

Mr Gray continued "This agreement is an important component of our objective to globally outlicense this product to companies that have the ability to rapidly establish market share for the product. Further activities are underway to expand our licensing network to cover all major global markets."

Zambon Group headquartered in Milan, Italy, is a multinational pharmaceutical company with an international presence in Europe, South America and Asia. Zambon has research and development capabilities, production facilities and sales and marketing organizations employing 2500 people. Zambon is developing a portfolio of products from prescription drugs to self-medication products primarily in the therapeutic areas of respitory, woman's care, pain relief and dermatology.

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.

Company details

If you want to find out more about the company visit Zambon Company SpA profile.

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