Alliance Pharmaceutical Corp. Announces Imavist Determined Approvable by the FDA.Business Editors/Health & Medical Writers BIOWIRE2K SAN DIEGO--(BW HealthWire)--March 1, 2002 Alliance Pharmaceutical Corp. (Nasdaq:ALLP ALLP Aldo Leopold Leadership Program ) (Nasdaq:ALLPD) announced today that 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. ) has completed its review of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Imavist(TM) (perflexane lipid microspheres), an ultrasound imaging agent, and found it to be approvable. Final product approval is dependent upon Alliance's submission of additional information related primarily to product labeling. The company expects to respond to the FDA within the next several weeks. The information that will be supplied to the FDA includes patient subgroup analyses, a recently completed pharmacokinetic report, and an updated plan for post-approval product release testing. As announced previously, Alliance had a successful pre-approval inspection of its manufacturing facility by the Los Angeles District Office of the FDA, which recommended approval for Imavist. "Based on discussions with the FDA, we are optimistic that we can submit a satisfactory response to the agency promptly, and we are moving ahead with our preparations for market launch of Imavist," said Duane J. Roth, chairman & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Alliance. "Along with our development partner, Schering AG, Germany, we are announcing a comprehensive sales, marketing, and distribution plan for Imavist today." Imavist is intended to assist in the diagnosis of heart disease, the leading cause of death in the United States. As many as 20 percent of the more than 17 million ultrasound images of the heart (echocardiograms) that are performed annually in the United States 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 may not provide adequate image quality for an accurate diagnosis. Imavist is expected to help patients with suboptimal echocardiograms by improving visualization of 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 assisting in the detection of cardiac abnormalities and allowing patients to receive appropriate treatment quickly without the need for more extensive testing. Contrast 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 contrast agents became effective in the second half of 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. Imavist is manufactured as a dry powder Dry Powder A slang term for cash reserves kept on hand to cover future obligations. Notes: For example, if a venture capitalist expects bad times in the IPO markets you might hear him say something like, "we want to keep enough dry powder around to keep funding our that allows for room temperature storage, and is ready to use with the addition of water. The product does not contain any blood-derived components. 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. Imavist is being developed jointly by Alliance and Schering AG, Germany. 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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