Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA’s Special Protocol Assessment procedure. At the same time, the company received Scientific Advice from the European Medicines Agency (EMEA) on Anthera’s European development strategy for varespladib. Guidance from both regulatory agencies regarding varespladib will be incorporated into Anthera’s global registration program slated to start next year.
Anthera completes special protocol assessment with FDA and receives EMEA scientific advice on development path toward varespladib approval
Anthera advances global development strategy for varespladib with the initiation of FRANCIS trial
Anthera Pharmaceuticals Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, today announced the initiation of the FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression) clinical trial designed to examine the impact of varespladib when administered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event.
Anthera advances global development strategy for varespladib with the initiation of FRANCIS trial
SAN MATEO, CA – August 25, 2008 – Anthera Pharmaceuticals Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, today announced the initiation of the FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression) clinical trial designed to examine the impact of varespladib when administered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event.
DSMB supports continuation of Anthera Phase 2 impacts trial for the prevention of acute chest syndrome in patients with sickle cell disease
Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has recommended that Anthera’s Phase II clinical trial, known as the IMPACTS (Investigation of the Modulation of Phospholipase in Acute ChesT Syndrome) Study can continue under the current protocol, without change.
DSMB supports continuation of Anthera Phase 2 impacts trial for the prevention of acute chest syndrome in patients with sickle cell disease
SAN MATEO, CA – April 16, 2008 – Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has recommended that Anthera’s Phase II clinical trial, known as the IMPACTS (Investigation of the Modulation of Phospholipase in Acute ChesT Syndrome) Study can continue under the current protocol, without change.
Anthera enters into manufacturing agreements for Varespladib in preparation for pivotal Phase 3 trials
Anthera Pharmaceuticals, Inc. today announced it has entered into manufacturing agreements with Albemarle Corporation and Patheon Inc. The agreements provide for the large-scale clinical production of Varespladib (A-002), which is expected to be necessary in preparation for Anthera’s Phase III clinical trials and planned New Drug Application submission to the Food and Drug Administration. Varespladib is Anthera’s oral drug candidate for the treatment of cardiovascular disease.
Anthera enters into manufacturing agreements for Varespladib in preparation for pivotal Phase 3 trials
SAN MATEO, CALIFORNIA - JANUARY 31, 2008 - Anthera Pharmaceuticals, Inc. today announced it has entered into manufacturing agreements with Albemarle Corporation and Patheon Inc. The agreements provide for the large-scale clinical production of Varespladib (A-002), which is expected to be necessary in preparation for Anthera’s Phase III clinical trials and planned New Drug Application submission to the Food and Drug Administration. Varespladib is Anthera’s oral drug candidate for the treatment of cardiovascular disease.
Anthera announces preliminary positive results from once-daily A-002 Phase 2 cardiovascular trial
SAN MATEO, CA – January 15, 2008 – Anthera Pharmaceuticals, Inc., a privately-held biopharmaceutical company, reported preliminary results of a second Phase IIb clinical trial of A-002, for the treatment of cardiovascular disease. In this second study, administration of once-daily A-002 lowered both sPLA2 and LDL-C levels confirming the positive effects of A-002 treatment seen in the twice-daily PLASMA study (Phospholipase Levels And Serological Markers of Atherosclerosis) announced in October 2007.
Anthera announces preliminary positive results from once-daily A-002 Phase 2 cardiovascular trial
Anthera Pharmaceuticals, Inc., a privately-held biopharmaceutical company, reported preliminary results of a second Phase IIb clinical trial of A-002, for the treatment of cardiovascular disease. In this second study, administration of once-daily A-002 lowered both sPLA2 and LDL-C levels confirming the positive effects of A-002 treatment seen in the twice-daily PLASMA study (Phospholipase Levels And Serological Markers of Atherosclerosis) announced in October 2007.
Anthera receives orphan drug status for the prevention of acute chest syndrome in patients with sickle cell disease
Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Product Development has granted A-001 orphan drug status for the prevention of acute chest syndrome in patients with sickle cell disease.
