Anaritide Acute Renal Failure Study Group.
We are disappointed that the results of this pivotal Phase III clinical trial of AURICULIN in oliguric acute renal failure failed to confirm the positive results we observed in a subgroup of patients in our first Phase III acute renal failure trial," said Richard L.
AURICULIN was under development in collaboration with Genentech, Inc.
after an interim analysis of data from an ongoing Phase
Scios Nova announced on May 2, 1995, that a preliminary analysis of its Phase III clinical study of Auriculin
(anaritide) for the treatment of acute renal (kidney) failure (ARF) revealed that Auriculin
did not reduce the need for dialysis in the broad patient population, nor did the drug reduce mortality, though it did reduce the need for dialysis in a prospectively defined subgroup.
NYSE: GNE) today announced that they have entered into a collaboration agreement for the development of Scios Nova's Auriculin (R) anaritide for the treatment of acute renal (kidney) failure (ARF), which is currently in Phase III clinical trials.
Under the terms of the agreement, Genentech and Scios Nova will collaborate in the development of Auriculin for ARF in the United States and Canada.
Phase III clinical trials of AURICULIN
as a treatment for oliguric acute renal failure are ongoing.
The timeline revision reflects the need to conduct a second AURICULIN Phase III clinical trial.
Under the revised AURICULIN timeline, Scios will receive an accelerated payment of $15 million upon the submission of a New Drug Application to the Food and Drug Administration (FDA) to market AURICULIN, provided the submission takes place before June 30, 1998.
Auriculin is in a Phase III trial for oliguric renal failure and Natrecor is in a Phase II trial for congestive heart failure.
It also has a strong financial position that should cover losses through the development cycle for Auriculin, and possibly Natrecor.