Cell Pathways Inc has signed an agreement with Sinclair Pharma Ltd to become the exclusive distributor of Gelclair Concentrated Oral Gel in North America. Cell Pathways plans to promote Gelclair initially in the oncology market for use in inflammation and ulceration of the mouth (referred to as mucositis or stomatitis) caused by chemotherapy or radiotherapy using its dedicated sales force. Cell Pathways also plans to seek a partner to promote Gelclair within oral surgery and other dental markets.

The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to market Gelclair in December 2001 for use in the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. These applications include oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy), irritation due to oral surgery and traumatic ulcers caused by braces or ill-fitting dentures or disease.

Gelclair is also indicated for treatment of diffuse aphthous ulcers. The product, which is a clear viscous gel, is applied by rinsing in the mouth for a short period of time, forming a coating over the mucosal surface of the mouth and thereby soothing the pain and discomfort from oral lesions.

Cell Pathways will make an initial payment and commitments to purchase inventory from Sinclair in calendar year 2002, totaling five million dollars. The term of the agreement is 10 years with provision for extension under certain circumstances. The company will purchase product from Sinclair Pharma Ltd. pursuant to forecasts to be adjusted from time to time subject to minimum purchase requirements. Under the agreement, Cell Pathways will become the exclusive distributor for the United States, Canada and Mexico. Sinclair is responsible for filing applications for marketing approval of Gelclair in Canada and Mexico.

Oral mucositis is an inflammation and ulceration of the lining of the mouth and throat most commonly associated with chemotherapy or radiotherapy for cancer. Patients often identify oral mucositis as the most unpleasant side effect of cancer therapy. Symptoms of oral mucositis may include ulcerations, redness, and swelling in the mouth. More severe side effects include extreme pain that may prevent the patient from eating and necessitate hospitalization and total parenteral nutrition, serious risk of infection and the interruption of cancer therapy.