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Celsion Receives COMP Recommendation for Orphan Drug Designation in Europe for ThermoDox® to Treat Primary Liver Cancer
Date:11/11/2010

COLUMBIA, Md., Nov. 11, 2010 /PRNewswire-FirstCall/ -- Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on the application for Orphan Drug Designation for ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer.  A positive opinion by the COMP immediately precedes official designation of ThermoDox® as an orphan drug by the EMA.  ThermoDox® is currently being evaluated under a Special Protocol Assessment with the FDA in a 600 patient pivotal Phase III trial (the HEAT study) in patients with non-resectable primary liver cancer at 76 clinical sites in 11 different countries.  ThermoDox® has previously received Orphan Drug designation by the U.S. Food and Drug Administration (FDA).  In addition, the HEAT study has been designated as a Fast Track Development Program by the FDA.

Orphan designation for a medicinal product by the EMA provides for scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, and certain financial incentives.  The designation also provides 10 years of marketing exclusivity subsequent to product approval.  Orphan drugs are eligible for full reduction of fees associated with pre-authorization inspections, as well as full reduction of marketing application fees and annual fees for qualifying companies.

"We are very pleased to receive a positive opinion from the Committee for Orphan Medicinal Products, which immediately precedes final Orphan Drug designation from the EMA, for ThermoDox®," stated Mr. Michael H. Tardugno,
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2. Data Monitoring Committee Unanimously Recommends Continuation of Celsions Phase III ThermoDox® HEAT Study to Treat Primary Liver Cancer
3. Celsion Receives SBIR Grant To Expand Its Technology Platform
4. Celsion Receives Fast Track Designation for ThermoDox® Development Program to Treat Primary Liver Cancer
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