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ActivBiotics Receives FDA Orphan Drug Designation for Superoxide Dismutase Mimetic, M40403, in Oral Mucositis of Cancer
Date:3/6/2008

WELLESLEY HILLS, Mass., March 6 /PRNewswire/ -- Joseph F. Finn, Jr., CPA, the Assignee for the Benefit of Creditors of ActivBiotics, announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted Orphan Drug Designation for M40403 for the prevention of radiation -- or chemotherapy -- induced oral mucositis (OM) in cancer patients.

The development of oral mucositis is a major, debilitating side-effect in the radiation and chemotherapy of cancer. Oral mucositis is one of the main reasons for poor compliance with and early discontinuation of therapy by patients being treated for their condition. Nearly half a million patients develop oral mucositis each year across all cancer indications, and of these 90% are associated with solid tumors. Although the estimated potential of the total oral mucositis market is $1- 2 billion, this therapeutic area is one of high unmet medical need, with few successful treatment options available.

By targeting various early stage inflammatory pathways implicated in the development of oral mucositis, M40403 may have particularly unique potential as a successful therapeutic in this disorder.

FDA's Orphan Drug Act was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect not more than 200,000 persons in the United States. Orphan Drug Designation provides an important economic incentive for the development of new products in the cancer field. US Orphan Designation provides for 7 years of market exclusivity, reduction regulatory fees, and additional regulatory support for R&D initiatives.

About M40403

This investigational small molecule mimics the action of a natural component of the cells, an enzyme called superoxide dismutase. Superoxide dismutase is thought to have a double pharmacologic effect during the earl
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