PLIVA, d.d., headquartered in Zagreb, Croatia, is now a global generics and specialty company, with operations in more than 30 countries
March 29, 2005 09:09 AM US Eastern Timezone
Odyssey Pharmaceuticals, Inc. Announces FDA Approval for Custodiol HTK Solution for Perfusion and Flushing of Donor Pancreata, in Addition to Previously Approved Liver, Kidney and Heart Transplants
FLORHAM PARK, N.J.--(BUSINESS WIRE)--March 29, 2005--Odyssey Pharmaceuticals, Inc. announced that the FDA has approved an additional indication for the use of Custodiol(R)* 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(R) 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 U.S., 22,141 (82%) were of kidneys and livers.(1) 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. For additional information about Custodiol or any other Odyssey products, please visit our website at www.OdysseyPharm.com or call 1-877-427-9068.
Odyssey Pharmaceuticals, Inc., a subsidiary of PLIVA, d.d., is a specialty pharmaceutical company dedicated to the research, development and commercialization of innovative products to improve quality of life. Since 2000, Odyssey has concentrated on key therapeutic categories such as urology, respiratory and central nervous system. The company recently launched SANCTURA(TM), a prescription medicine that is indicated for the treatment of overactive bladder (OAB). An estimated 33 million Americans suffer from OAB, with symptoms of urge urinary incontinence, urgency and urinary frequency. For more information, visit www.sanctura.com.
About PLIVA, d.d.
With more than 80 years of experience in the pharmaceuticals area, PLIVA, d.d., headquartered in Zagreb, Croatia, is now a global generics and specialty company, with operations in more than 30 countries in the U.S., Central and Eastern Europe and Western Europe. Building upon a strong R&D history, the company specializes in the discovery, development, production and distribution of generic and branded pharmaceutical products. Since its listing on the London Stock Exchange in 1996, PLIVA has established a fully internationalized business, with the majority of its revenues now realized in Western markets.
(1)The Organ Procurement and Transplantation Network. National data. Donors recovered in the U.S. by donor type. Available at: http://www.optn.org/latestData/rptData.asp. Accessed March 31, 2003.
*CUSTODIOL is a registered trademark of Dr. Franz Kohler Chemie GmbH, Alsbach-Hahnlein, Germany.