Press Releases
Distributed: Dec 13, 2010
Melbourne, Dec 13, 2010 (ABN Newswire) - Benitec Limited (ASX:BLT) (PINK:BNIKF) is pleased to announce that the European Patent Office (EPO) has issued a Communication of Intent to Grant on application 2005 727 680 "Multiple promoter expression cassettes for simultaneous delivery of RNAi agents". The claims cover the use of an RNA interference construct (with multiple promoters) to inhibit the level of Hepatitis C virus in cells, tissues and organs. Additional related applications remain pending to extend the scope of protection, including constructs having single promoters.
Benitec has licensed the rights to use this patent for Hepatitis C exclusively to Tacere Therapeutics, Inc., who are working with Pfizer to further develop and commercialise Tacere's Hepatitis C Virus (HCV) compounds.
Tacere Therapeutics' Chief Executive Officer Sara Hall Renison stated "We are very pleased with the news from the EPO. Benitec has been a strong ally in developing this and other patent families, and Tacere and Pfizer look forward to continuing clinical development of this first-in-class drug".
Benitec's Chief Executive Officer Dr Peter French said, "The intention of the EPO to grant this patent is an important addition to our already broad and robust patent portfolio in RNAi, and complements the patents already granted for this work in the United States, Australia and New Zealand."
About Benitec Limited
Benitec Limited (ASX:BLT) (PINK:BNIKF) is an Australian biotechnology company focused on licensing its extensive intellectual property portfolio and developing therapeutics to treat serious diseases using its proprietary ddRNAi technology. For additional information, please visit http://www.benitec.com/.
Contact
Peter French
Chief Executive Officer
Benitec Limited
Tel: +61-412-457-595
http://www.benitec.com/
Source
December 12, 2010
Pfizer Withdraws Thelin; Blood Pressure Drug Linked to Fatal Liver Damage
By AP Dec 10th 2010 10:33AM
Categories: News
Pfizer Inc. said Friday it is pulling its blood pressure drug Thelin off the market and stopping all clinical trials because the drug can cause fatal liver damage.
Thelin is sold in the European Union, Canada, and Australia as an oral treatment for severe pulmonary arterial hypertension, or high blood pressure in the pulmonary artery. Pfizer said two patients who were taking Thelin died during a clinical trial, and a review of data from clinical studies and post-marketing reports showed a new link to liver injury.
Liver damage was a known side effect of Thelin and similar drugs, the company said, but the review uncovered a link to liver damage that was not tied to identifiable risk factors. It said the problem was unlikely to be detected by routine monitoring, and in some cases, the problems did not go away after patients stopped taking Thelin.
Pfizer said the withdrawal was voluntary and added that it has withdrawn its filing for marketing approval in the U.S.
Since there are other treatment options, Pfizer said the benefits of Thelin don't outweigh the risks. It is stopping all studies of the drug, which Pfizer acquired in 2008 when it bought Encysive Pharmaceuticals Inc. Encysive had been trying to win marketing approval for Thelin since 2005, but the Food and Drug Administration said it was not effective enough. Other agencies only approved the drug for hypertension that was so debilitating that patients' physical activity was severely limited.
The New York company said worldwide sales of Thelin, or sitaxsentan, totaled $44.4 million in the first nine months of 2010.
Source
Categories: News
Pfizer Inc. said Friday it is pulling its blood pressure drug Thelin off the market and stopping all clinical trials because the drug can cause fatal liver damage.
Thelin is sold in the European Union, Canada, and Australia as an oral treatment for severe pulmonary arterial hypertension, or high blood pressure in the pulmonary artery. Pfizer said two patients who were taking Thelin died during a clinical trial, and a review of data from clinical studies and post-marketing reports showed a new link to liver injury.
Liver damage was a known side effect of Thelin and similar drugs, the company said, but the review uncovered a link to liver damage that was not tied to identifiable risk factors. It said the problem was unlikely to be detected by routine monitoring, and in some cases, the problems did not go away after patients stopped taking Thelin.
Pfizer said the withdrawal was voluntary and added that it has withdrawn its filing for marketing approval in the U.S.
Since there are other treatment options, Pfizer said the benefits of Thelin don't outweigh the risks. It is stopping all studies of the drug, which Pfizer acquired in 2008 when it bought Encysive Pharmaceuticals Inc. Encysive had been trying to win marketing approval for Thelin since 2005, but the Food and Drug Administration said it was not effective enough. Other agencies only approved the drug for hypertension that was so debilitating that patients' physical activity was severely limited.
The New York company said worldwide sales of Thelin, or sitaxsentan, totaled $44.4 million in the first nine months of 2010.
Source
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