Alliance Pharmaceutical Corp. Announces FDA Agreement On Oxygent Phase 3 Clinical Program.

SAN DIEGO--(BW HealthWire)--Sept. 14, 1999--

Alliance Pharmaceutical Corp. (Nasdaq:ALLP) announced today that it has reached agreement with the Food and Drug Administration (FDA) on the key design features of the Phase 3 program for Oxygent(TM), an intravascular oxygen carrier ("blood substitute") intended to reduce the need for donor blood transfusions in surgical patients.

Oxygent will be studied in a Phase 3 clinical (human) trial in the U.S. involving patients undergoing coronary artery bypass grafting (CABG) surgery under cardiopulmonary bypass (CPB). This study, which is expected to start shortly, will complement a Phase 3 trial currently underway with general surgery patients in eight European countries. Oxygent is the only blood substitute in clinical development that is formulated from a synthetic raw material (emulsified perflubron) and not derived from human or bovine blood.

The U.S. Phase 3 study will be conducted at approximately 30 medical centers with an enrollment of 600 patients, half of whom will be treated with Oxygent according to Alliance's proprietary Augmented Acute Normovolemic Hemodilution (A-ANH(TM)) technique. The trial will assess the effectiveness of Oxygent in reducing the incidence of red blood cell transfusions, and thus avoiding exposure to donor blood. Oxygent has been investigated in numerous previous clinical trials involving more than 500 subjects, including five Phase 2 studies (two in general surgery and three in cardiac surgery).

Approximately 8-10 million patients worldwide undergo general surgery procedures each year wherein one to four units of donor blood are anticipated to be transfused. In addition to the well-publicized risks of infectious disease transmission (e.g., HIV, hepatitis) and potential immune suppression effects related to blood transfusions, there are emerging concerns regarding the availability and quality of donor blood.

The National Blood Data Resource Center (NBDRC) recently released data showing that blood donations have decreased while blood usage has increased over the past several years. These trends have led the NBDRC to predict that beginning next year (2000) the U.S. will experience a deficit of approximately 250,000 units of red blood cells available for transfusion.

This expected blood shortage may be further exacerbated by the FDA's Aug. 17, 1999 recommendation to prohibit donations from individuals who spent a cumulative six months in the United Kingdom between the years 1980 and 1996, and are therefore potentially at risk of having been exposed to infected beef that may be linked to new variant Creutzfeld-Jakob Disease (CJD).

Concerns regarding the quality of donor blood relate to the "storage lesion" effect -- a progressive deterioration of red blood cell function that occurs during storage. This reduces the immediate oxygen transport effectiveness of the donor red cells, which are typically stored for up to six weeks prior to their use in transfusions.

These issues have heightened the search for alternatives that reduce or eliminate the need for donor blood in elective surgeries and are not subject to the storage lesion effect. Oxygent is a sterile emulsion that is compatible with all blood types and is expected to have a shelf-life of two years. It is manufactured using a cost-effective, proprietary process at Alliance's commercial-scale facility that has the potential to produce approximately one million units annually.

Alliance Pharmaceutical Corp. is a pharmaceutical research and development company with three products in late-stage clinical development, each addressing a different medical need. In addition to Oxygent, Alliance's principal products are LiquiVent(R), an intrapulmonary "liquid ventilation" agent for treatment of acute lung injury and acute respiratory distress syndrome; and Imagent(R), an ultrasound contrast agent being developed with Schering AG, Germany.

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 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. 333-76343).