Alliance Pharmaceutical Corp. Wins Patent Interference Against Nycomed Imaging, AS.Business Editors & Health/Medical/Legal Writers BIOWIRE2K SAN DIEGO--(BW HealthWire)--Sept. 20, 2001 Alliance Pharmaceutical Corp. (Nasdaq:ALLP ALLP Aldo Leopold Leadership Program ) announced today that it has won a favorable Final Judgment from the United States Patent and Trademark Office's Board of Patent Appeals and Interferences The Board of Patent Appeals and Interferences (BPAI) is a body of the United States Patent and Trademark Office (USPTO), which decides issues of patentability. If an applicant for an invention cannot convince a patent examiner that they are entitled to their claims, then the regarding claims in U.S. Patent No. 5,558,854, which is owned by Nycomed Imaging, AS (formerly owned by Sonus Pharmaceuticals, Inc.). The Final Judgment determined that claims made in the Nycomed patent with respect to "microbubbles" that contain perfluorohexane (PFH PFH Partners for Health PFH Putters From Heaven PFH Population and Family Health Program (World Bank) ) gas are invalid and are therefore unpatentable. "Microbubbles" are microscopic bubbles that can be utilized as contrast agents to enhance ultrasound imaging. PFH vapor is a particularly useful component of microbubble mi·cro·bub·ble n. An extremely small bubble, usually only a few hundred micrometers in diameter, that can be uniformly suspended in a liquid such as blood. preparations because it is biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function. , biologically inert, and it stays in the bubbles longer than similar gases, improving the persistence of the contrast effect. Imavist(TM) (AF0150), an ultrasound contrast agent comprised of PFH-based microbubbles, is being developed jointly by Alliance and Schering AG, Germany, and is awaiting final approval from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). Contrasted ultrasound imaging is gaining attention because it is less expensive and less invasive than other diagnostic imaging methods. New Medicare laws that allow for reimbursement of procedures using ultrasound agents became effective in July 2001. Under the new regulations, the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and created additional Ambulatory Payment Classifications that define ultrasound contrast agents as drugs and allow them to be eligible for pass-through payments at 95 percent of the average wholesale price. More than 17 million ultrasound images of the heart (echocardiograms) are performed annually in the U.S. to aid in the diagnosis of heart disease, the leading cause of death in the United States. Approximately 20 percent of these echocardiograms are considered suboptimal Suboptimal A solution is called suboptimal if a part of the solution has been optimized without regards to the overall objective. and do not provide adequate image quality for an accurate diagnosis. Imavist is expected to help patients with suboptimal echocardiograms by improving visualization of the main pumping chamber and the walls of the heart (endocardial endocardial /en·do·car·di·al/ (-kahr´de-al) 1. situated or occurring within the heart. 2. pertaining to the endocardium. endocardial 1. situated or occurring within the heart. 2. border delineation), thereby enabling better detection of structural and functional defects and allowing patients to receive appropriate treatment quickly without the need for more extensive testing. Imavist has been evaluated in several clinical trials, including two Phase 3 studies with approximately 500 patients that successfully demonstrated a clinically and highly statistically significant improvement in endocardial border delineation compared to standard (non-contrast) ultrasound imaging. The FDA has reviewed a New Drug Application for Imavist and found it to be approvable upon satisfactory response to issues identified in the review process. Alliance has submitted documentation to the FDA that it believes fully addresses these issues, and the company is therefore expecting final approval and permission for marketing Imavist in the U.S. Alliance Pharmaceutical Corp. is developing therapeutic and diagnostic products based on its perfluorochemical and surfactant Surfactant Definition Surfactant is a complex naturally occurring substance made of six lipids (fats) and four proteins that is produced in the lungs. It can also be manufactured synthetically. 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 Corp. 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 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. and Form 10-Q Form 10-Q See 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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