Celsion Files Process Change Supplement with FDA
COLUMBIA, MD, June 27, 2006 - Celsion Corporation (AMEX: CLN) announced today that, as anticipated during its shareholder conference call on June 21, 2006, a supplement revising its Prolieve Thermodilatation® disposable kit PMA manufacturing process was filed with the FDA on June 26, 2006. The supplement has been accepted by the FDA for real time review.
Dr. Lawrence Olanoff, Celsion's President and Chief Executive Officer said "We believe, if the FDA agrees with our requested manufacturing changes, having this supplement accepted for real time review will result in the most expeditious return of the Prolieve® disposable catheter kits to the market. While this interruption of production has been financially burdensome to Celsion, we are confident that upon approval we should be able to rapidly reestablish supply with a high quality, lower cost product."
ABOUT CELSION: Celsion Corporation, based in Columbia, Maryland, is a biotechnology company dedicated to the development and commercialization of heat activated treatment systems for cancer.
Celsion has research, license or commercialization agreements with leading institutions such as the National Institute of Health, Duke University Medical Center, Massachusetts Institute of Technology, Harbor UCLA Medical Center, Montefiore Medical Center and Memorial Sloan-Kettering Cancer Center in New York City, Roswell Park Cancer Institute in Buffalo, New York, and Duke University. For more information on Celsion, visit our website: www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. In addition, Celsion's receipt of the royalty payments in connection with the sale of Celsion (Canada) depends upon the ability of Celsion (Canada) to develop the APA technology and bring products to market. This involves, among other risks of a new enterprise, financing, regulatory and market acceptance risks.
For Further Information Contact:
Tony Deasey
Celsion Corporation
410.290.5390
tony@celsion.com
General Info: Marilynn Meek
Financial Relations Board
212-827-3773
mmeek@financialrelationsboard.com
Investor Info: Susan Garland
212-827-3775
sgarland@financialrelationsboard.com
