Odyssey Pharmaceuticals, Inc. announced that the FDA has approved an additional indication for the use of Custodiol HTK Solution for the perfusion and flushing of donor pancreata. Custodiol HTK Solution has already been approved for use in the perfusion and flushing of other key donor organs -- livers, kidneys and hearts. Custodiol now presents with indications for the vast majority of organ transplants in the United States - both abdominal and thoracic organs - an important consideration for transplant specialists.

"With this new indication, Custodiol makes an excellent single product choice for the large majority of transplant procedures involving pancreata, hearts, kidneys, and livers," said Wayne Yetter, president and CEO of Odyssey.

According to statistics compiled by The Organ Procurement and Transplantation Network, during 2004, of the 26,998 organs transplanted from all donors in the US, 22,141 (82 per cent) were of kidneys and livers. Another 2,013 were heart transplants, 602 were pancreas or islet cell transplants and 880 were kidney/pancreas transplants. This makes the pancreas the fourth most commonly transplanted solid organ.

"This new indication for Custodiol also demonstrates the commitment that Odyssey has made to the field of transplantation. For example, PLIVA, Inc., an affiliated company, offers Cyclosporine Soft-Gel Capsules and Oral Solution. In addition, a dedicated team of Odyssey/PLIVA Transplant Specialists presents these products to the medical community," added Allan Weber, senior director, sales and marketing at Odyssey.

Custodiol offers several important advantages over other available products. Custodiol requires no flushing of the organ prior to transplantation. Custodiol requires no additives, filtering, or premixing, and it can be stored over a wider range of temperatures (2 degrees C - 15 degrees C (35 degrees F - 59 degrees F)). The low viscosity of Custodiol -- similar to water -- and its clear appearance make for easier handling for both the perfusionist and the surgeon. Adding to its ease of handling, Custodiol is packaged in 4 sizes -- 500-mL bottles, 1000-mL bottles, 2000-mL bags, and 5000-mL bags -- for greater convenience.