Alliance Pharmaceutical Corp. Announces FDA Approval of Imagent Ultrasound Imaging Agent.Business Editors and Health/Medical Writers BIOWIRE2K SAN DIEGO--(BW HealthWire)--June 3, 2002 Imagent May Improve the Diagnosis of Heart Disease, the Leading Cause of Death in the U.S. Alliance Pharmaceutical Corp. (Nasdaq:ALLP ALLP - Aldo Leopold Leadership Program)(Nasdaq:ALLPD) announced today that its ultrasound imaging agent, Imagent(R) (perflexane lipid microspheres), has been approved for marketing by the U.S. Food and Drug Administration (FDA). Imagent, formerly known as Imavist, provides clinically important anatomical information about the heart not obtainable using echocardiography color Doppler echocardiography color flow Doppler imaging. contrast echocardiography that in which the ultrasonic beam detects tiny bubbles produced by intravascular injection of a liquid or a small amount of carbon dioxide gas. Doppler echocardiography (ultrasound of the heart) alone. The product will be marketed by Alliance in partnership with Cardinal Health, Inc. (NYSE:CAH), a leading provider of products and services to the healthcare industry, and inChord Communications, Inc., one of the largest independent healthcare communications companies in the world. Imagent will be introduced to the cardiology community at the June 9-12 meeting of the American Society of Echocardiography in Orlando, Florida. Echocardiography is the most widely used imaging modality for the diagnosis of heart disease, the leading cause of death in the U.S. Imagent has been approved for use in patients with suboptimal echocardiograms ech·o·car·di·o·gram ( k![]() -kär d to opacify the left ventricle and thereby improve visualization of the main pumping chamber of the heart, and to improve delineation of the endocardial endocardial /en·do·car·di·al/ (-kahr´de-al) 1. situated or occurring within the heart. 2. pertaining to the endocardium. borders (walls) of the heart. As a result, ultrasound with Imagent may better distinguish normal and abnormal heart structure and function -- two critical indicators of cardiac health. The incidence of heart disease is increasing due to shifts in demographics toward an older population and an increase in obesity. An estimated 17.5 million echocardiograms were performed last year in the U.S., of which up to 20% produced suboptimal images, primarily due to the patient's size or body structure. "The FDA's approval of Imagent, which was designed and developed by Alliance, is a significant achievement for the company," said Duane J. Roth, Chairman and CEO of Alliance. "We are excited that a product derived from our core perfluorochemical technologies will be able to assist in the diagnosis of heart disease. Our team of dedicated specialists will provide focused marketing and educational support to integrate the use of Imagent as a standard of care in echocardiography. "When used in conjunction with ultrasound imaging, Imagent enhances the contrast between different types of tissues, improving the clarity of echocardiograms," Roth explained. "New ultrasound equipment with specific modes that incorporate the use of a contrast agent have been introduced recently by major manufacturers. We are eager to participate in this growing opportunity to address the needs of cardiac patients." Commenting on the approval of Imagent, Howard Dittrich, MD, Sr. vice president and chief medical officer at Alliance, and clinical professor of Medicine in Cardiology at the University of California, San Diego, noted, "Echocardiography is an indispensable component in the management of patients with known or suspected heart disease. The addition of Imagent to this technology should further advance the field by potentially improving diagnostic utility." Imagent is manufactured from synthetic materials, and packaged as a dry powder in a ready-to-use kit that is stored at room temperature. The powder is reconstituted with water to form an osmotically stabilized suspension of microscopic spheres, or "microspheres", containing a perfluorochemical (perflexane) vapor and physiologic gases. Imagent is then injected intravenously into a patient undergoing a cardiac ultrasound exam. Imagent has no known contraindications; however, the product should be administered with caution to patients with cardiac shunts or severe pulmonary vascular disease. The overall incidence of adverse events is similar to that of placebo (saline), and adverse events occurring with a low frequency included headache, hypertension, and nausea. Imagent is manufactured by Alliance using the company's proprietary technology. A series of patents has been issued to Alliance covering methods of forming stable microsphere formulations, spray-drying processes to make a powder that facilitates product shipping and storage, methods of using contrast agents in conjunction with conventional and harmonic ultrasound, and related technologies. Additional patent applications are pending in the U.S. and elsewhere. Alliance is the first company to participate in Rxpedite(SM), a new strategic partnership between Cardinal Health and inChord that provides comprehensive sales and marketing services. Cardinal Health will hire, train, and deploy a dedicated Alliance sales force and ultrasound medical liaison specialist team. In addition, the Pharmaceutical Technologies and Services segment of Cardinal Health will provide commercial packaging services, and the company's Pharmaceutical Distribution and Provider Services segment will provide customer service, invoicing, and accounts receivable services. Cardinal Health is also extending to Alliance a revolving line of credit, which will be repaid from product revenues. inChord will provide a broad range of marketing services for Imagent through its consulting company, CHS; its advertising agency, Gerbig, Snell/Weisheimer (GSW GSW - Gateway Science Workshop (Northwestern University, Evanston, Illinois) GSW - Gateway Switch (Sonus Networks) GSW - Generalized Sliding Window GSW - Georgia Southwestern State University, Americus, Georgia GSW - GeoScienceWorld GSW - German Stampede Wrestling GSW - Get Smart Week GSW - Girls Soccer World (USA) GSW - Gold Star Wives of America GSW - Golden State Warriors GSW - Governor's School West GSW - Grand Senior Warden); its interactive marketing company, Blue Diesel; its data management and analytics company, Health Process Management (HMP), and its medical education firm, S.G. Madison. Alliance and its marketing partners will introduce Imagent at the upcoming American Society of Echocardiography meeting in Florida, which will be attended by cardiologists, sonographers, and other healthcare professionals. Imagent will be covered by current Medicare reimbursement regulations. Alliance Pharmaceutical Corp. is developing therapeutic and diagnostic products based on its perfluorochemical and surfactant technologies. Alliance's products are intended primarily for use during acute care situations, including surgical, cardiology, and respiratory applications. Oxygent(TM) (perflubron emulsion), an intravenous oxygen carrier, is being developed in the United States, Canada, and Europe in conjunction with Baxter Healthcare Corporation. Additional information about the Company is available on Alliance's web site at www.allp.com. Except for historical information, the matters set forth in this release are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth herein, including the availability of funding for development, the uncertainties associated with the conduct of preclinical or clinical studies and the timing or ability to investigate scientific data. Alliance refers you to cautionary information contained in documents the Company files with the Securities and Exchange Commission from time to time, including the last Form 10-K and Form 10-Q, and those risk factors set forth in the most recent registration statement on Form S-3 (File No. 333-47032) and Form S-4 (File No. 333-49676). Alliance is under no obligation (and expressly disclaims any obligation) to update or alter its forward-looking statements, whether as a result of new information, future events, or otherwise. |
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