Alliance Pharmaceutical Corp. Announces Receipt of FDA Approvable Letter for Imagent
SAN DIEGO--(BW HealthWire)--Aug. 21, 2000--Alliance Pharmaceutical Corp. (NASDAQ:ALLP - news) announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the FDA has completed its review of the New Drug Application (NDA) for Imagent® (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 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 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 technologies. Alliance's products are intended primarily for use during acute care situations, including surgical, cardiology, and respiratory applications. Oxygent(TM), an intravascular 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®, 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. Additional information about the company is available on Alliance's Web site at allp.com.
biz.yahoo.com |
