By Randall Osborne
West Coast Editor
Still talking with the FDA about starting another Phase III study with Oxygent (perflubron emulsion), its intravascular oxygen carrier, Alliance Pharmaceutical Corp. said it reached an agreement in principle to raise at least $15 million in a private placement with undisclosed institutional investors.
¿We expect [the financing] to be completed upon shareholder approval at our annual meeting Oct. 15,¿ said Gwen Rosenberg, vice president of corporate communications, adding that she was limited in what she could say, since the deal is yet to be finalized.
San Diego-based Alliance said proceeds will help advance Imavist, an ultrasound contrast agent being developed with Frankfurt, Germany-based Schering AG, and to resume the development of Oxygent in the United States, Canada and Europe with Baxter Healthcare Corp., of Deerfield, Ill.
¿It was held up,¿ Rosenberg said. ¿We had completed a successful Phase III in Europe with patients undergoing general surgery, but we had suspended a Phase III in the U.S. with patients undergoing cardiac surgery. The problem was due to the procedure, not the drug, and we¿re working with the FDA to start a new Phase III study.¿ (See BioWorld Today, March 14, 2001, and April 10, 2001.)
Another oxygen-carrying perflubron product, Liquivent, failed to meet its primary or secondary endpoints in a Phase II/III trial with patients with acute respiratory distress syndrome, but Alliance said it had not given up on it entirely. ¿We¿re no longer pursuing it for treating adult patients on ventilators,¿ Rosenberg said. (See BioWorld Today, May 23, 2001.)
Regarding Imavist, the imaging agent, a new drug application has been reviewed by the FDA and was found to be approvable, upon satisfactory response to certain issues raised by the agency. Rosenberg earlier said approval is expected later this year.
Alliance¿s stock (NASDAQ:ALLP) closed Friday at $1.20, down 9 cents.