Corautus Genetics Signs Manufacturing Agreement with Qiagen and Strathmann Biotec AG for VEGF-2 Plasmid Production.Business Editors/Health/Medical Writers ATLANTA--(BUSINESS WIRE)--Jan. 8, 2004 Corautus Genetics Inc. (AMEX AMEX See: American Stock Exchange : CAQ CAQ Center for Audit Quality (New York, New York) CAQ Certificat d'Acceptation du Quebec CAQ Computer-Aided Quality Assurance CAQ Certificate of Added Qualification CAQ Computer-Aided Quality Control CAQ Condition Adverse to Quality ) has signed a manufacturing agreement with Qiagen NV (Nasdaq: QGENF; Frankfurt, Prime Standard: QIA QIA Qualified Intermediary Agreement (US IRS) QIA Quality Investment Act ) and Strathmann Biotech AG to produce VEGF-2 plasmid for anticipated Phase III trials and future commercial use. The Company has in inventory the VEGF-2 plasmid required for its upcoming Phase IIb clinical trial. Richard Otto, Chief Executive Officer of Corautus, commented, "Signing this manufacturing agreement is an important building block as we look beyond our Phase IIb trial to plan for Phase III trials and projected future commercialization of our product. We have decided to enter into this agreement now because it gives us the assurance that if the timelines for the trials and commercialization get accelerated, we are guaranteed a slot in the manufacturing cycle. It also enables us to do advanced planning for quality control and assurance that will be part of this process." Mr. Otto continued, "We thoroughly evaluated various potential manufacturing partners, and are confident that QIAGEN and Strathmann are best-suited to meet Corautus' scientific specifications, quality requirements and development schedule." The VEGF-2 plasmid will be produced at Strathmann's newly-built facility in Dengelsberg, Germany. The facility was designed and built specifically for plasmid DNA production. Bert Behnke, Chief Scientific Officer of Strathmann, stated, "We are very pleased that Corautus has chosen us to manufacture their product which will be used to help treat cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease . Our state-of-the-art facilities are ideal for producing the high-quality VEGF-2 plasmid that will be required to comply with the standards of the regulatory agencies." Corautus' therapy, which is considered regenerative medicine, seeks to treat the underlying causes of severe coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. through direct injection of VEGF-2 into ischemic Ischemic An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery. Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation ischemic cardiac muscle cardiac muscle n. The muscle of the heart, consisting of anastomosing transversely striated muscle fibers formed of cells united at intercalated disks; the myocardium. Also called muscle of heart. . 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 Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. 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. The Company believes that there are several advantages to this over other gene transfer delivery systems including minimal side effects Side effects Effects of a proposed project on other parts of the firm. and the fact that the gene is not inserted into the genome. Dr. Joachim Schorr, QIAGEN's Managing Director and Senior Vice President Global Research & Development, noted, "We have completed numerous projects with Strathmann for pre-clinical and clinical trials. Strathmann's strong plasmid DNA manufacturing capabilities combined with QIAGEN's expertise in nucleic acid nucleic acid, any of a group of organic substances found in the chromosomes of living cells and viruses that play a central role in the storage and replication of hereditary information and in the expression of this information through protein synthesis. purification, reflected in our products and technologies, addresses the highest requirements in purity and efficiency of plasmid DNA manufacturing for gene therapy applications." About Corautus Genetics Corautus Genetics Inc. is a clinical stage biopharmaceutical company dedicated to the development of gene transfer therapy products for the treatment of severe cardiovascular and peripheral vascular disease Peripheral Vascular Disease Definition Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. . Corautus is currently developing and testing a gene transfer product using the Vascular Endothelial Growth Factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature). 2 (VEGF-2) gene to promote therapeutic angiogenesis in ischemic muscle. In July 2003, Corautus entered into a series of agreements with Boston Scientific Corporation to fund, develop, commercialize and distribute the VEGF-2 gene therapy products. About QIAGEN QIAGEN N.V., a Netherlands holding company with subsidiaries in Germany, the United States, Japan, the United Kingdom, Switzerland, France, Italy, Australia, Norway, Austria and Canada, believes it is the world's leading provider of innovative enabling technologies and products for the separation, purification and handling of nucleic acids Nucleic acids The cellular molecules DNA and RNA that act as coded instructions for the production of proteins and are copied for transmission of inherited traits. . The Company has developed a comprehensive portfolio of more than 320 proprietary, consumable products for nucleic acid separation, purification and handling, nucleic acid amplification, as well as automated instrumentation, synthetic nucleic acid products and related services. QIAGEN's products are sold in more than 42 countries throughout the world to academic research markets and to leading pharmaceutical and biotechnology companies. In addition, the Company is positioning its products for sale into developing commercial markets, including DNA sequencing and genomics, nucleic acid-based molecular diagnostics, and genetic vaccination and gene therapy. QIAGEN employs approximately 1,600 people worldwide. Further information on QIAGEN can be found at www.qiagen.com. About Strathmann Biotech AG Strathmann Biotec AG is an expanding biotechnology company based in Hamburg, Germany. Founded in 1987 as Pharma Biotechnologie Hannover, it was one of the first manufacturers of recombinant proteins in Germany. Since 1997 it is part of the Strathmann Group and a subsidiary of Strathmann AG, a leading mid-sized pharmaceutical company in Germany. Strathmann Biotec offers its contract development and contract manufacturing services to international customers from the pharmaceutical and biotechnology industry. The company has long-standing experience in the area of protein expression systems, plasmid DNA technologies, downstream processing as well as manufacturing. Further information on Strathmann Biotech AG can be found at http://www.strathmann-biotec-ag.de/en/company/comphome.shtml. Forward Looking Statement This press release may contain forward-looking statements made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 future results of operations or our financial condition, benefits from the alliance with Boston Scientific, synergies from the merger between GenStar and Vascular Genetics, research, development and commercialization of our product candidates, anticipated trends in our business, approval of our product candidates 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 risks discussed in Corautus' Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. (File No. 001-15833) filed March 28, 2003, which are incorporated by reference into this press release. |
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