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Alliance Pharmaceutical Corp. Announces Receipt of FDA Approvable Letter for Imagent.


Business Editors and Health/Medical Writers

BIOWIRE2K

SAN DIEGO--(BW HealthWire)--Aug. 21, 2000

Alliance Pharmaceutical Corp. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:ALLP ALLP Aldo Leopold Leadership Program ) announced today that it has received a letter 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.
) stating that the FDA has completed its review of the 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 Imagent(R) (AF0150), and found it to be approvable.

Imagent, an ultrasound contrast agent, is being developed jointly by Alliance and Schering AG, Germany.

The NDA for Imagent was submitted to the FDA in October 1999 and contained data from two Phase 3 studies in which the product was used to improve ultrasound images 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). Detailed data from these studies, which enrolled approximately 500 patients at multiple medical centers in the United States, are being prepared for publication.

"We are pleased to receive an approvable notification from the FDA," 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. "An approvable status is typically one of the final steps before the FDA grants clearance for marketing a new pharmaceutical product in the U.S. We will work closely with the FDA to satisfy the remaining requirements, and we are looking forward to final approval and permission for marketing Imagent 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), an intravascular intravascular /in·tra·vas·cu·lar/ (in?trah-vas´ku-lar) within a vessel.

in·tra·vas·cu·lar
adj.
Within one or more blood vessels.
 oxygen carrier, is in Phase 3 clinical development to reduce the need for donor blood during surgery. On May 12, 2000, the company and Baxter Healthcare Corp. announced an agreement for the manufacturing, sales and distribution of Oxygent in the United States, Canada and Europe. LiquiVent(R), an intrapulmonary "liquid ventilation" agent, is being evaluated in a pivotal Phase 2-3 study in North America and Europe for treatment of acute lung injury and acute respiratory distress syndrome acute respiratory distress syndrome
n.
See adult respiratory distress syndrome.
. Additional information about the company is available on Alliance's Web site at http://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. 333-33242).
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Publication:Business Wire
Geographic Code:1USA
Date:Aug 21, 2000
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