ANN ARBOR, MI, USA I February 2, 2015 I Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of hypercholesterolemia and other cardio-metabolic risk markers, today announced the U.S. Food and Drug Administration (FDA) has removed the peroxisome proliferator-activated receptor (PPAR) partial clinical hold on ETC-1002. The action by the FDA will now allow Esperion to conduct clinical trials exceeding six months in duration.
“We are pleased to receive a positive and rapid response from the FDA following our submission in early January of a complete response to the PPAR partial clinical hold,” said Tim M. Mayleben, president and chief executive officer of Esperion. “The removal of the PPAR partial clinical hold is an important milestone on the path toward initiation of our Phase 3 clinical program for ETC-1002 later this year.”
Conference Call and Webcast Details The Esperion management team will host a conference call and webcast today at 4:30 p.m. Eastern Time (ET). The live event will be accessible on the investor relations section of the Esperion website at www.esperion.com, or by calling (877) 831-3840 (domestic) or (253) 237-1184 (international). The access code is 78973905. A replay of the event will be available approximately one hour after completion and will be archived on the Company’s website for approximately 90 days following the event.
Esperion’s Commitment to Cardiometabolic Disease Esperion is committed to improving the lives of patients with cardiometabolic diseases. The Esperion team leverages its understanding of, and experience with, key biological pathways to discover and develop innovative therapies for the treatment of patients with hypercholesterolemia who have uncontrolled cholesterol levels despite the use of currently available therapies. Esperion has assembled a portfolio of programs including one product candidate in late-stage clinical evaluation (ETC-1002) and two pre-clinical product candidates.
About Esperion Therapeutics Esperion Therapeutics, Inc. is an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, LDL-cholesterol-lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers. ETC-1002, Esperion’s lead product candidate, is a unique, first-in-class, orally available, once-daily small molecule designed to lower LDL-cholesterol levels and avoid the side effects associated with therapies currently available for lowering LDL-cholesterol. ETC-1002 is being developed primarily for patients with hypercholesterolemia and a history of statin intolerance. For more information, please visit www.esperion.com and follow us on Twitter at https://twitter.com/EsperionInc.
SOURCE: Esperion Therapeutics
Post Views: 93
ANN ARBOR, MI, USA I February 2, 2015 I Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of hypercholesterolemia and other cardio-metabolic risk markers, today announced the U.S. Food and Drug Administration (FDA) has removed the peroxisome proliferator-activated receptor (PPAR) partial clinical hold on ETC-1002. The action by the FDA will now allow Esperion to conduct clinical trials exceeding six months in duration.
“We are pleased to receive a positive and rapid response from the FDA following our submission in early January of a complete response to the PPAR partial clinical hold,” said Tim M. Mayleben, president and chief executive officer of Esperion. “The removal of the PPAR partial clinical hold is an important milestone on the path toward initiation of our Phase 3 clinical program for ETC-1002 later this year.”
Conference Call and Webcast Details The Esperion management team will host a conference call and webcast today at 4:30 p.m. Eastern Time (ET). The live event will be accessible on the investor relations section of the Esperion website at www.esperion.com, or by calling (877) 831-3840 (domestic) or (253) 237-1184 (international). The access code is 78973905. A replay of the event will be available approximately one hour after completion and will be archived on the Company’s website for approximately 90 days following the event.
Esperion’s Commitment to Cardiometabolic Disease Esperion is committed to improving the lives of patients with cardiometabolic diseases. The Esperion team leverages its understanding of, and experience with, key biological pathways to discover and develop innovative therapies for the treatment of patients with hypercholesterolemia who have uncontrolled cholesterol levels despite the use of currently available therapies. Esperion has assembled a portfolio of programs including one product candidate in late-stage clinical evaluation (ETC-1002) and two pre-clinical product candidates.
About Esperion Therapeutics Esperion Therapeutics, Inc. is an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, LDL-cholesterol-lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers. ETC-1002, Esperion’s lead product candidate, is a unique, first-in-class, orally available, once-daily small molecule designed to lower LDL-cholesterol levels and avoid the side effects associated with therapies currently available for lowering LDL-cholesterol. ETC-1002 is being developed primarily for patients with hypercholesterolemia and a history of statin intolerance. For more information, please visit www.esperion.com and follow us on Twitter at https://twitter.com/EsperionInc.
SOURCE: Esperion Therapeutics
Post Views: 93
