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Sopherion Therapeutics, Inc. Receives FDA Fast Track Designation for Myocet in Metastatic Breast Cancer


1/7/2010 10:29:14 AM

PRINCETON, N.J., Jan. 7 /PRNewswire/ -- Sopherion Therapeutics, LLC, a biopharmaceutical company focused on the development and commercialization of anti-cancer therapies, announced today that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for nonpegylated liposomal doxorubicin (Myocet(TM)) for first-line therapy of HER2 positive metastatic breast cancer. Treatment with Myocet(TM) has already shown a reduced level of cardiotoxicity as compared to traditional doxorubicin.

"Myocet has the potential of delivering the well-documented efficacy of doxorubicin to patients with an acceptable safety profile when compared to earlier products in this class," said Ronald H. Goldfarb, Ph.D., President and CEO of Sopherion Therapeutics. "There is significant medical need for new breast cancer treatments and we look forward to reporting results from our ongoing pivotal Phase III trial by the end of 2010."

About Sopherion Therapeutics, LLC

Sopherion Therapeutics, LLC is a privately-held biotechnology company based in Princeton, New Jersey. The Company is focused on developing novel anti-cancer therapies for patients suffering from advanced cancer, particularly in the metastatic stage. Sopherion is dedicated to the acquisition, discovery, development and commercialization of novel anti-cancer therapies with unique therapeutic activities that address unmet medical needs in and extend human life. In 2004, Sopherion entered into an exclusive licensing agreement with Zeneus Pharma Ltd., now Cephalon, Inc. to develop and commercialize Myocet in North America. For more information, visit www.sopherion.com.

CONTACT: Matthew Driscoll, BMC Communications Group, LLC, +1-212-477-9007
x20, mdriscoll@bmccommunications.com

Web site: http://www.sopherion.com/


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