Introgen Therapeutics Inc announced that Advexin, its investigational adenoviral p53 product candidate, has received orphan drug designation by the U. S. Food and Drug Administration (FDA). This designation provides incentives for companies developing products for rare diseases. Advexin is currently being evaluated in two randomized, controlled phase 3 clinical studies for head and neck cancer patients.
The Orphan Drug Act defines products used to treat diseases or conditions affecting fewer than 200,000 persons in the United States. Such small patient populations reduce profit potential for sponsors, thus the act grants special privileges and marketing incentives. A company may be granted marketing exclusivity for seven years in the United States upon approval of an orphan drug. Other benefits of orphan drug status include tax credits on clinical research expenses incurred in development of the product and the option to reduce and/or waive certain significant fees associated with filing product approval applications.
"Head and neck cancer is a disease that, although affecting a smaller population than some other indications for which we are developing Advexin such as lung cancer, has dismal survival rates and a disease for which few novel therapies are in development," said Dr. Max Talbott, Introgen's senior vice president of worldwide commercial development. "Additionally, the marketing exclusivity for approved orphan drugs is an incentive for us to develop this product as rapidly as possible," he continued.