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Clinical Studies of OvaRex in Advanced Ovarian Cancer Fail to Meet Primary Endpoint
Date:12/5/2007

T I and II preliminary results is ongoing and full data from the IMPACT trials is expected to be presented at an upcoming medical meeting and published in a peer-reviewed journal.

OvaRex MAb-B43.13 (oregovomab) is one of five investigational immunotherapeutic monoclonal antibodies which Unither Pharmaceuticals licensed in April 2002 from AltaRex Medical Corp., a wholly-owned subsidiary of ViRexx Medical Corp. Based on the preliminary results from the IMPACT trials, Unither Pharmaceuticals intends to terminate the license agreement and intends to cease further development of the entire platform of antibodies. United Therapeutics is currently determining the amount of exit costs associated with termination of this program. While a precise estimate of write-down charges is not yet known, United Therapeutics has approximately $7 million in assets related to this program that are subject to write-down during the fourth quarter of 2007.

"Given what appeared to be the promising clinical activity observed in a subset of patients from an earlier phase II trial, we are very surprised by these findings. The IMPACT trials, which were well designed and rigorously conducted, indicate that the approach of triggering tumor-specific immunity using a murine monoclonal antibody has its challenges," said Christopher Nicodemus, MD, Unither Pharmaceuticals' Senior Vice President Clinical Research & Development.

"We are all disappointed that OvaRex did not make it to the finish line as a new therapeutic for ovarian cancer, and we owe a huge debt of gratitude to the women and physicians who participated in the studies," said Peter Gonze, Unither Pharmaceuticals' Chief Operating Officer.

About Ovarian Cancer

Ovarian cancer is the fifth leading cause of cancer deaths among women in the United States. The American Cancer Society estimates that in the United States this year, there will be over 20,000 new cases of ovarian cancer diagnosed and over 15,000 wome
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SOURCE United Therapeutics Corporation
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