Corautus Genetics Inc. Enters Into Long Term Manufacturing Agreement With Boehringer Ingelheim Austria GmbH for Production of VEGF-2 Plasmid DNA
Monday May 16, 8:00 am ET
ATLANTA and VIENNA, Austria, May 16 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. (Nasdaq: VEGF - News) and Boehringer Ingelheim Austria GmbH announced today that they have entered into a long term manufacturing agreement to produce VEGF-2 (Vascular Endothelial Growth Factor 2) plasmid DNA for a Phase III trial and future commercial use for the treatment of cardiovascular disease (severe angina) and other indications.
Richard E. Otto, Chief Executive Officer of Corautus stated, "We are pleased to enter this agreement with Boehringer Ingelheim Austria as we look beyond our ongoing Phase IIb trial (GENASIS) and begin planning the Phase III trial and projected future commercialization of our therapeutic for severe angina. Both the Corautus team and the Boehringer Ingelheim Austria team have devoted considerable time and resources necessary to complete this important agreement. Since it is a multi-year commitment for each company, Boehringer Ingelheim Austria began the feasibility and GMP implementation activities several months ago in order to meet the projected timelines for a Phase III registration trial of the VEGF-2 therapeutic."
Mr. Otto continued, "Boehringer Ingelheim Austria was selected for our manufacturing activities based upon its ability to produce to commercial specifications and its leadership position in the global biotechnology community. The facility in Vienna is scalable and will also accommodate the quantities necessary to expand our therapeutic portfolio of clinical initiatives for the treatment of cardiac and peripheral vascular disease. In addition, the facility is FDA certified for commercial manufacturing of biopharmaceutical therapeutics."
Dr. Kurt Konopitzky, Head of Division Biopharmaceuticals / Operations at Boehringer Ingelheim Austria stated, "We are excited about the opportunity to work with Corautus and our decision underscores the value of Corautus' clinical programs. Our objective was to develop scaleable and competitive plasmid manufacturing technology to serve our world-wide clients. With titers of up to 1 g pDNA per Liter fermentation suspension and drug substance purity of 99%, the plasmid DNA manufacturing technology we have developed has set the standard in the biopharmaceutical industry."
Corautus' cardiac therapy, which is considered regenerative medicine, seeks to treat the underlying causes of severe coronary artery disease through direct injection of VEGF-2 into ischemic cardiac muscle. Based on data from earlier clinical trials - Phase I and IIa have been completed - Corautus believes that when VEGF-2 is introduced into ischemic cardiac muscle, it will stimulate the growth of new blood vessels and improve cardiac function. The VEGF-2 is delivered via a non-viral vector system in which the naked DNA plasmid is injected directly into the tissue where the gene transfer occurs. Corautus believes that there are several advantages to this over other gene transfer delivery systems including minimal side effects and the fact that the gene is not inserted into the genome. |
