ATLANTA and VIENNA, Austria, May 16 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. 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.
About the GENASIS Trial
GENASIS is a randomized, double-blinded, dose-ranging and placebo- controlled Phase IIb clinical trial, which will enroll 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. The GENASIS trial will be conducted in approximately 30 cardiac medical centers throughout the United States.
In the GENASIS trial, defined doses of VEGF-2 in the form of "naked" plasmid DNA, a non-viral delivery vector, are delivered to diseased heart muscle tissue via the Boston Scientific Corporation Stiletto(TM) endocardial direct injection catheter system. The injection procedure is performed by a cardiologist in a standard cardiac laboratory.
VEGF-2 is a growth factor that is believed to promote the development of supplemental collateral blood vessels, a process known as therapeutic angiogenesis. Once administered, the DNA plasmid appears to be taken up and expressed by myocardium near the injection site. Inside the cell, the DNA plasmid then enters the nucleus of the cell without a requirement of incorporation into the genomic DNA. The Phase IIb clinical trial expects to see the effect of the expression of DNA-encoded VEGF-2, which in turn stimulates the growth of new blood vessels by promoting the migration and proliferation of endothelial cells in the heart.
About Corautus Genetics Inc.
Corautus Genetics Inc. is a clinical-stage biopharmaceutical company dedicated to the development of gene transfer therapy products for the treatment of cardiovascular (severe angina) and peripheral vascular disease. Corautus is currently developing and testing a gene transfer product using the Vascular Endothelial Growth Factor-2 (VEGF-2) gene to promote therapeutic angiogenesis in ischemic muscle. In July 2003, Corautus entered into a strategic alliance with Boston Scientific Corporation to develop, commercialize and distribute the VEGF-2 gene therapy products. For more information, please visit http://www.corautus.com/ .
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 45 countries and nearly 36,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
With two biotech sites for development and production, Boehringer Ingelheim is one of the leading companies with a strong reputation in production of biopharmaceuticals using mammalian cell culture, native and recombinant microorganism and yeast. Boehringer Ingelheim Austria GmbH, based in Vienna, is the center of competence for microbial fermentation technology. More info can be found at http://www.boehringer-ingelheim.com/ and http://www.boehringer-ingelheim.com/biopharm .
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain factors, risks and uncertainties that may cause actual results, events and performances to differ materially from those referred to in such statements. These risks include statements which address operating performance, events or developments that we expect or anticipate will occur in the future, such as projections about our ongoing clinical trial, potential benefits from manufacturing agreements, the potential benefits from previous clinical trials, sufficient enrollment of suitable patients in our clinical trial, future results of operations or our financial condition, adequacy of funding, benefits from the alliance with Boston Scientific, research, development and commercialization of our product candidates, anticipated trends in our business, manufacture of sufficient and acceptable quantities of our proposed products, approval of our product candidates, meeting additional capital requirements, and other risks that could cause actual results to differ materially. These risks are discussed in Corautus Genetics Inc.'s Securities and Exchange Commission filings, including, but not limited to, the risk factors in Corautus' 2004 Annual Report on Form 10-K which was filed on March 22, 2005, which are incorporated by reference into this press release.
CONTACT: Investor and Media Relations, Michael K. Steele of Corautus Genetics Inc., 404-526-6212, firstname.lastname@example.org ; Dr. Monika Henniger, Head of Customer Relations and Projects, of Boehringer Ingelheim Austria GmbH, +43-1-80105-2141
Corautus Genetics Inc.