Possible Treatment For World's Most Common, Life-Threatening
Genetic Disease Receives 'Fast Track' Status From Government

Exciting Advancement Provides Hope for 600,000 Americans Living with PKD

(Kansas City) February 23, 2006 — The Food and Drug Administration has granted “Fast Track” designation for Tolvaptan, a potential treatment for the dominant form of polycystic kidney disease (PKD). PKD affects more people than Down syndrome, cystic fibrosis, muscular dystrophy, sickle cell anemia and hemophilia combined.

Fast track programs through the FDA are designed to speed up the development and review of new drugs with exciting potential to treat serious or life-threatening conditions.

For the 600,000 Americans suffering from PKD, fluid-filled cysts grow throughout the kidneys. Over time, these cysts get bigger and multiply, often leading to kidney failure. There is no treatment or cure for PKD, but there is hope.

Tolvaptan is being evaluated as a way to stop or slow cyst growth in PKD patients. It may also help alleviate complications of PKD, including increased renal size, hypertension, proteinuria and renal pain.

Phase II studies for Tolvaptan are complete, and global Phase III clinical trials are expected to begin soon. The PKD Foundation, the only organization in the world dedicated to funding research for PKD, supported basic research leading to the clinical trial of this drug.

March is National Kidney Month, and PKD patients across the country are available for interviews on the disease and potential treatments. For more information, visit www.pkdcure.org or call 1-800-PKD-CURE. To learn more about the Tolvaptan clinical trials, contact Otsuka Maryland Research Institute, Inc., at 1-866-712-5837 or http://www.otsuka.com/.