Actinium Pharmaceuticals Inc (ATNM)

[LGL8054]

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.2 Orphan designation qualifies the sponsor of the drug for various development incentives including marketing exclusivity in the U.S. for seven years after product approval3, tax credits, and exemption from the prescription drug user fee.

Sources: 1U.S. Ovarian Cancer http://seer.cancer.gov/statfacts/html/ovary.html; 2FDA Website - Developing Products for Rare Diseases & Conditions; 3FDA Frequently Asked Questions on Patents and Exclusivity